nalbuphine and Pain--Postoperative

Nalbuphine has been increasingly used as a local anesthetic adjuvant to extend the duration of analgesia in brachial plexus block (BPB).. To systematically and firstly evaluate the available evidence on the efficacy of nalbuphine as an adjuvant to local anesthetics in BPB.. Systematic review and meta-analysis.. Cochrane Central Register of Controlled Clinical Trials, Cochrane Database of Systematic Reviews, Medline, Embase, Scopus, Web of Science, EBSCO, PubMed, and additional databases were searched. Randomized controlled trials comparing combination of perineural nalbuphine with local anesthetics to local anesthetics alone in BPB for upper extremity surgical procedures were eligible for inclusion.. Nineteen randomized controlled trials involving 1,355 patients met the inclusion criteria. Perineural use of nalbuphine prolonged the duration of analgesia in BPB (mean difference [MD], 162.5; 95% confidence interval [CI], 119.0 to 205.9; P < 0.00001; very low quality of evidence). The duration of sensory block was also extended (MD, 141.6; 95% CI, 100.3 to 182.9; P < 0.00001; very low quality of evidence). Furthermore, nalbuphine shortened the onset time of sensory block (MD, -2.6; 95% CI, -3.6 to -1.5; P < 0.00001; very low quality of evidence). There were no significant differences in side effect-related outcomes, including nausea (risk radio [RR], 1.56; 95% CI, 0.82 to 2.59; P = 0.17; moderate quality of evidence) and vomiting (RR, 1.41; 95%  CI, 0.66 to 3.02; P = 0.38; moderate quality of evidence).. The study was limited by substantial heterogeneity, a relatively small sample size and difference-in-differences in how outcomes of interest were described and assessed.. Perineural use of nalbuphine in BPB is an effective strategy for analgesia in adult patients undergoing upper extremity surgery.

Topics: Adjuvants, Anesthesia; Adult; Anesthesia, Local; Anesthetics, Local; Brachial Plexus Block; Humans; Nalbuphine; Pain, Postoperative

To evaluate the evidence of analgesic efficacy of tramadol for the management of postoperative pain and the presence of associated adverse events in dogs.. A comprehensive search using PubMed/MEDLINE, LILACS, Google Scholar and CAB databases with no restrictions on language and following a prespecified protocol was performed from June 2019 to July 2020. Included were randomized controlled trials (RCTs) performed in dogs that had undergone general anesthesia for any type of surgery. Two authors independently classified the studies, extracted data and assessed their risk of bias using Cochrane's tool. RevMan and GRADE methods were used to rate the certainty of evidence (CoE).. Overall 26 RCTs involving 848 dogs were included. Tramadol administration probably results in a lower need for rescue analgesia versus no treatment or placebo [moderate CoE; relative risk (RR): 0.47; 95% confidence interval (CI): 0.26-0.85; I

Topics: Analgesia; Animals; Dog Diseases; Dogs; Nalbuphine; Pain Management; Pain, Postoperative; Tramadol

Opioid-induced pruritus is prevalent after neuraxial administration of opioid. A number of preventive measures have been reported; however, only a few studies evaluated treatment strategies for established pruritus. The pharmacokinetics and pharmacodynamic profiles of nalbuphine make this drug ideal for the treatment of established pruritus. The primary outcome of this systematic review and meta-analysis was the incidence of pruritus after neuraxial opioid administration. Secondary outcomes were the incidence of sedation and postoperative nausea and vomiting. Pooled estimates were reported by calculating the risk ratio (RR) with 95% confidence interval (CI). Five trials consisting of 494 patients were included for analysis. There was a low quality of evidence that nalbuphine was effective in reducing the incidence of pruritus compared with active control (RR, 0.59; 95% CI, 0.38 to 0.93; P = .02). Conversely, there was no difference between the incidence of sedation (RR, 1.06; 95% CI, 0.42 to 2.71; P = .90) and postoperative nausea and vomiting (RR, 1.58, 95% CI, 0.75 to 3.31; P = .23). Although large studies are needed to decrease heterogeneity across studies, the current review showed that nalbuphine appears to reduce the incidence of opioid-induced pruritus.

Topics: Analgesics, Opioid; Humans; Morphine; Nalbuphine; Nurse Anesthetists; Pain, Postoperative; Postoperative Nausea and Vomiting; Pruritus

According to current recommendations a multimodal approach is believed to be the gold standard for postoperative pain treatment in children. However, several surveys in the last few years demonstrated that postoperative pain in children is still a serious problem, mainly because opioids are avoided. One of the reasons for this is the fear of severe adverse events following opioid administration. Tramadol is a weak mu-opioid agonist and inhibits reuptake of noradrenaline and serotonin (5HT). Because of a relatively wide therapeutic window and a ceiling effect with a lower risk for severe adverse events (for example respiratory depression) tramadol is a widely used opioid in children. However, the exact efficacy and occurrence of adverse events following tramadol (in comparison with placebo or other opioids) for postoperative pain treatment in children and adolescents are currently not clear.. To assess the effectiveness and side effect profile of tramadol for postoperative pain relief in children and adolescents undergoing different surgical procedures.. We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 6), MEDLINE via PubMed (January 1966 to July 2014) and EMBASE via Ovid (January 1947 to July 2014). There were no restrictions regarding language or date of publication. The reference lists of all included trials were checked for additional studies.. All randomised controlled clinical trials investigating the perioperative administration of tramadol compared to placebo or other opioids for postoperative pain treatment in children and adolescents were included.. Three review authors independently assessed the study eligibility, performed the data extraction and assessed the risk of bias of included trials.. Twenty randomised controlled trials involving 1170 patients were included in this systematic review. The overall risk of bias in included trials was assessed as unclear, because concealment of allocation processes and blinding of outcome assessors were poorly described. Due to inconsistent outcome reporting, data from 17 included trials could be pooled for some endpoints only. Eight trials compared tramadol administration with placebo and five trials found that the need for rescue analgesia in the postoperative care unit (PACU) was reduced in children receiving tramadol (RR 0.40; 95% CI 0.20 to 0.78; low quality evidence). Only one trial investigated the number of patients with moderate to severe pain, but a non-validated pain scale was used (very low quality evidence). Four trials compared morphine with tramadol administration. There was no clear evidence of difference in the need for rescue analgesia in the PACU (RR 1.25; 95% CI 0.83 to 1.89; low quality evidence) with tramadol compared with morphine. No trials could be pooled for the outcome 'number of patients with moderate to severe pain'. Three trials were included for the comparison of tramadol with nalbuphine. There was no clear evidence for the need for rescue analgesia in the PACU (RR 0,63; 95% CI 0.16 to 2.45; low quality evidence). Only one trial reported the number of patients with moderate to severe pain, but used a non-validated pain scale (very low quality evidence). Two out of six included trials, which compared pethidine with tramadol, reported the number of children with a need for rescue analgesia within the PACU and showed no clear evidence (RR 0.93; 95% CI 0.43 to 2.02; very low quality evidence). Two trials reported the number of patients with moderate to severe pain and showed a lower RR in patients treated with tramadol (RR 0.64; 95% CI 0.36 to 1.16; low quality evidence). Only one trial was included, which compared tramadol with fentanyl, reporting the number of patients with the need for rescue analgesia (very low quality evidence). Generally, adverse events were poorly reported. Most data could be pooled for the comparison with placebo focusing on the RR for postoperative nausea and vomiting (PONV) in the postoperative care unit and 24 h postoperation. Children treated with tramadol, compared to placebo, did not show clear evidence of benefit for PONV in the postoperative care unit (RR 0.84; 95% CI 0.28 to 2.52; moderate quality evidence) and 24 h postoperation (RR 0.78; 95% CI. The overall evidence regarding tramadol for postoperative pain in children is currently low or very low and should be interpreted with caution due to small studies and methodological problems (different validated and non-validated pain scales with different pain triggers, missing sample size calculations and missing intention-to-treat analysis). Nevertheless, we demonstrated that tramadol administration might provide appropriate analgesia when compared to placebo; this is based on results showing reduced rescue analgesia in children treated with tramadol compared to placebo. In contrast, the evidence regarding the comparison with other opioids (for example morphine) was uncertain. Adverse events were only poorly reported, so an accurate risk-benefit analysis was not possible.

Topics: Adolescent; Analgesics, Opioid; Child; Child, Preschool; Female; Fentanyl; Humans; Infant; Male; Meperidine; Morphine; Nalbuphine; Pain, Postoperative; Randomized Controlled Trials as Topic; Tramadol

Nalbuphine is an agonist-antagonist opioid. It causes analgesic and sedative effect and because of ceiling effect it does not cause a respiratory depression. In a perioperative therapy of paediatric patients it may be used for premedication, sedation during diagnostic procedures as well as for postoperative pain treatment. It reverses adverse reactions of other opioids such as itch or urinary retention, not significantly influencing its analgetic properties. After sevoflurane anaesthesia of small children, it reduces the incidences of emergence agitation. Nalbuphine is considered a safe drug, which causes nausea and vomiting less frequently than other opioids. Analgesic effect, the ability to provide moderate sedation and a large margin of safety make that analgesic often used for paediatric patients.

Topics: Analgesics, Opioid; Anesthesia; Child; Humans; Methyl Ethers; Nalbuphine; Narcotic Antagonists; Pain, Postoperative; Sevoflurane

Efficient and safe pediatric perioperative pain therapy in the context of a multimodal pain therapy concept requires a slight to moderate opioid analgesic. Nalbuphine is a nearly ideal opioid for this purpose due to its unique pharmacological properties as a μ-receptor antagonist/κ-receptor agonist and a high safety profile. Nalbuphine is used clinically primarily in postoperative pain therapy administered as a bolus, continuous infusion and patient-controlled analgesia. Furthermore, it is administered in different regimens for pediatric diagnostic and interventional sedation.

Topics: Analgesia, Patient-Controlled; Analgesics, Opioid; Anesthesia, Intravenous; Anesthetics, Intravenous; Child; Conscious Sedation; Drug Combinations; Humans; Hypnotics and Sedatives; Monitoring, Physiologic; Nalbuphine; Narcotics; Pain, Postoperative; Preoperative Care; Receptors, Opioid, kappa; Receptors, Opioid, mu

Several surveys over the past few years have demonstrated that postoperative pain in children is not treated appropriately. One pharmacological treatment option in a multimodal approach for postoperative pain treatment is the systemic administration of opioids. However, opioids are rarely used for postoperative pain treatment in children due to fear of adverse events. One long-standing opioid for systemic use is nalbuphine, a kappa-receptor agonist and µ-receptor antagonist. The efficacy of nalbuphine is believed to be similar to morphine. Increased dosing might result in a ceiling effect, and thus less analgesia than expected. In addition, there might be a lower risk for opioid-induced side effects (nausea, vomiting) and severe adverse events (respiratory depression) due to the antagonistic effect of the µ-receptor. Nalbuphine may be an useful opioid for postoperative use in children, but exact efficacy (e.g. compared to other commonly used opioids) has not been determined yet.. To assess the efficacy and adverse events of nalbuphine for acute postoperative pain treatment in children undergoing surgery.. We systematically searched the following databases: The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 7), MEDLINE via Pubmed (January 1966 to July 2013) and EMBASE via Ovid (January 1947 to July 2013). We did not impose any restrictions regarding language or publication date. We checked all reference lists of retrieved articles for additional references.. All randomised controlled trials (RCTs) investigating nalbuphine compared with placebo or other opioids were included.. Two review authors independently scanned the retrieved articles and made a decision regarding inclusion or exclusion of studies for this review. The same authors also performed the data extraction and the assessment of risk of bias.. Ten RCTs including 658 patients were finally included in this systematic review. Five trials compared nalbuphine with placebo. Data from one out of five studies for the outcome moderate/severe pain following nalbuphine compared to placebo gave a risk ratio (RR) 1 hour postoperatively (postop) of 0.1 (95% confidence interval (CI) 0.01 to 0.71; low quality evidence) and a RR 2 hours postop of 0.14 (95% CI 0.02 to 1.06; low quality evidence). The estimated RR based on data from a single study indicated that nalbuphine reduced the requirement for analgesia two hours postop (RR 0.47; 95% CI 0.27 to 0.84; low quality evidence). Two included trials compared nalbuphine with morphine and showed a nonsignificant lower or comparable RR for moderate/severe pain at 1 hour postop (RR 0.84; 95% CI 0.12 to 5.74; low quality evidence), and 2 hours postop (RR 1.09; 95% CI 0.59 to 2.01; low quality evidence) for nalbuphine versus morphine. Four trials compared nalbuphine with tramadol for postoperative pain; data from one trial (per outcome) revealed a lower but nonsignificant RR for the need of additional rescue analgesics in children receiving nalbuphine (RR 2 hours postop 0.75; 95% CI 0.39 to 1.43; low quality evidence) (RR 12 hours postop 0.33; 95% CI 0.04 to 2.77; low quality evidence). One out of three trials comparing nalbuphine with pethidine demonstrated that the RR was not significantly lower following nalbuphine administration compared to pethidine (RR 2 hours postop 1.07; 95% CI 0.52 to 2.23; low quality evidence) (RR 24 hours postop 1.13; 95% CI 0.52 to 2.44; very low quality evidence). The most common adverse event was postoperative nausea and vomiting (PONV). Only one included trial reported that the RR for PONV in the postoperative care unit (PACU) was not significantly higher following nalbuphine compared to placebo (RR 1.00; 95% CI 0.16 to 6.42; low quality evidence) nor to morphine (RR 1.33; 95% CI 0.64 to 2.77; low quality evidence).. Because the overall quality of available evidence was low, this systematic review could not definitively show that the analgesic efficacy of nalbuphine is superior compared to placebo. Furthermore, due to the lack of significant results the comparison with other common opioids is also unclear. The same holds true for the evidence focusing on adverse events following nalbuphine compared to placebo or other opioid administration. The evidence is limited, because studies did not report conclusively all important postoperative pain outcomes (e.g. number of patients with the need for rescue analgesia, postoperative pain scores). Thus, a quantitative analysis was not possible for many major aspects (e.g. rescue analgesia, pain scores) and heterogeneity could not be further explored.

Topics: Adolescent; Analgesics, Opioid; Child; Child, Preschool; Humans; Meperidine; Morphine; Nalbuphine; Pain, Postoperative; Randomized Controlled Trials as Topic; Tramadol; Young Adult

Topics: Central Nervous System; Hemodynamics; Humans; Nalbuphine; Pain, Postoperative; Respiration

Laparoscopic sleeve gastrectomy (LSG) is a common bariatric surgery. Regional anesthetic techniques decrease postoperative pain, narcotic analgesic requirements, and opioid-related adverse effects in patients scheduled for bariatric surgery.. The research team conducted this clinical trial to assess the effects of bilateral ultrasound (US)-guided erector spinae plane block (ESPB) on postoperative pain scores and postoperative analgesics consumption compared with bilateral US-guided quadratus lumborum block (QLB) in the first 24 hours following LSG.. A randomized, double-blind, prospective, single-center study.. Ain-Shams University Hospitals.. Patients: One hundred twenty morbidly obese patients were scheduled for LSG.. Were randomly assigned to 3 groups (40 each): bilateral US-guided ESPB, bilateral US-guided QLB, or control (C) group.. The time to first rescue analgesia (ketorolac) was considered as a primary outcome. The time to perform the block, the duration of anesthesia, the time to first ambulation, the visual analog scale (VAS) at rest, VAS at movement, the total nalbuphine consumption (mg), the total requirements of rescue analgesia (ketorolac) over the first 24 hours after surgery and the study safety profile were considered as secondary outcomes.. The time to perform the block and the duration of anesthesia were higher in the QLB group compared to other groups, with significant differences between ESPB and C groups (P < 0.001, P < 0.001, respectively). The ESPB and QLB groups were superior to the C group as regards the time to first rescue analgesia, the total dose of rescue analgesia, and the total nalbuphine consumption (P < 0.001, P < 0.001, P < 0.001, respectively). In the C group, VAS-R and VAS-M readings were higher in the first 18 hours after surgery (P < 0.001, P < 0.001, respectively). In the rest 6 hours of 24 hours after surgery, the QLB group had lower VAS-R and VAS-M readings than the C group (P < 0.001, P < 0.001, respectively). More patients in the C group had higher incidences of nausea and vomiting (P = 0.011, P = 0.002, respectively). In the C group, the time to first ambulation, the length of PACU stay, and the hospital stay were higher in comparison to the ESPB and QLB groups (P < 0.001, P < 0.001, P < 0.001, respectively). More patients in the ESPB and QLB groups were satisfied with postoperative pain management protocol (P < 0.001).. The lack of postoperative respiratory assessment (e.g., spirometry) precluded the identification of either ESPB or QLB effects on pulmonary functions in such patients.. Bilateral ultrasound-guided erector spinae plane block and bilateral ultrasound-guided quadratus lumborum block provided adequate postoperative pain control and reduced postoperative analgesic requirements for morbidly obese patients scheduled for laparoscopic sleeve gastrectomy with priority to bilateral erector spinae plane block.

Topics: Analgesia; Analgesics, Opioid; Gastrectomy; Humans; Ketorolac; Laparoscopy; Nalbuphine; Nerve Block; Obesity, Morbid; Pain, Postoperative; Prospective Studies; Ultrasonography, Interventional

A long-acting κreceptor agonist parenteral analgesic may theoretically improve acute pain and reduce incidence of chronic postsurgical pain (CPSP) after laparoscopic cholecystectomy with minimal drug-related side effects of the traditional μreceptor opioids.. Eighty adult patients undergoing elective laparoscopic cholecystectomy were randomly assigned to receive single intramuscular injection of an extended-release sebacoyl dinalbuphine ester (SDE, Naldebain 150 mg; n = 40) or placebo (n = 40) after anesthesia induction. Standard multimodal analgesia (MMA) was administered for postoperative pain control. The primary endpoint was pain intensity within 7 days after surgery. The secondary endpoints were incidence CPSP at 3 months and adverse reactions up to 7 days after surgery.. The highest visual analogue scale (VAS) and area under the curve of VAS 0 to 48 hours after operation were not different between the two groups and a similar proportion of patients requested rescue parenteral analgesics. Average pain intensities were also not different at 72 hours and 7 days after surgery. Incidence of CPSP was 22.5% and 13.1% in patients who received placebo and SDE treatment, respectively (P = .379). Significantly higher incidence of drug-related adverse events, including dizziness, nausea and injection site reactions, were recorded in the SDE group.. A single dose of extended-release analgesic SDE given intraoperatively did not provide sufficient add-on effect for acute and chronic pain management after laparoscopic cholecystectomies in patients who received standard postoperative MMA. Intramuscular injection of 150 mg SDE in patients with average body mass causes adverse events that could have been overlooked. More clinical studies are warranted to determine the target populations who may benefit from SDE injections for improvement of acute and chronic postsurgical pain management.

Topics: Adult; Analgesics; Analgesics, Opioid; Cholecystectomy, Laparoscopic; Double-Blind Method; Humans; Nalbuphine; Pain, Postoperative

Severe postoperative pain requiring opioid treatment has been reported in 20% to 40% of hemorrhoidectomy patients. Compared with morphine, nalbuphine offers better hemodynamic stability, a lower risk of respiratory depression, and a lower potential for addiction. Nalbuphine was developed from the intravenous form into an oral form (PHN131) to alleviate moderate-to-severe pain.. A randomized, double-blind, placebo-controlled, multiple-dose, parallel-design trial was conducted to evaluate the safety and efficacy of PHN131 in patients undergoing hemorrhoidectomy. Eligible patients were randomly assigned to receive either PHN131 soft capsules containing nalbuphine hydrochloride 60 mg or placebo capsules. Intramuscular diclofenac was the rescue analgesic. Pain was measured by the area under the curve of mean Visual Analog Scale pain intensity scores.. Visual Analog Scale results in patients receiving PHN131 were significantly lower than placebo group scores through 48 hours postoperatively (149.2±75.52 vs. 179.6±65.97; P =0.0301). According to Brief Pain Inventory Short-Form scores, the impact of pain on quality of life was significantly smaller for the PHN131 group than for the placebo group. Time to the first use of diclofenac postoperatively was significantly longer in the PHN131 group than in the placebo group. The cumulative dosage of diclofenac in the PHN131 group was only around half of that in the placebo group ( P <0.0001). Drug-related adverse events were mild-to-moderate and resolved by the treatment end. No drug-related severe adverse events were observed.. Our findings demonstrate that PHN131 is effective and well-tolerated in the treatment of moderate-to-severe post hemorrhoidectomy pain and may provide another option for patients to control their pain.

Topics: Analgesics, Opioid; Diclofenac; Double-Blind Method; Hemorrhoidectomy; Humans; Nalbuphine; Pain, Postoperative; Quality of Life

Erector spinae plane block (ESPB) is an easy and safe method for postoperative analgesia. However its effect lasts only for several hours. This trial was to investigate the effectiveness of different doses of nalbuphine as an adjuvant to ropivacaine in ESPB for patients undergoing percutaneous nephrolithotomy (PCNL).. Patients scheduled for PCNL were randomized into three groups and received ultrasound-guided ESPB at T. The median [interquartile range, IQR] time to first opioid demand was significantly longer in group RNH (8.70 [6.90,14.85] h) than that of group R and group RNL (2.90 [2.00,6.30] h and 5.80 [2.95,7.00] h, respectively). VAS scores (either resting or active) within 24 h postoperatively were comparable between the three groups, with the most significant differences especially at 4, 6, 8 h. Morphine consumption at 24 h postoperatively was significant for R group vs RNH group (median difference, 9; 95% confidence interval [CI], 1.57 to 16.43; p = 0.02).. Adding 20mg nalbuphine to ropivacaine in ESPB could significantly improve the effect of analgesia and prolong the duration of nerve blocks for PCNL.

Topics: Adjuvants, Immunologic; Analgesics; Analgesics, Opioid; Humans; Morphine; Nalbuphine; Nephrolithotomy, Percutaneous; Nerve Block; Pain, Postoperative; Ropivacaine

This study aimed to compare the effect of dexamethasone added to fentanyl and bupivacaine with the effect of either dexamethasone or fentanyl alone when combined with bupivacaine in the thoracic paravertebral block (TPVB).. Sixty female patients (aged 18-60 years), scheduled for modified radical mastectomy were enrolled. Patients received preoperative unilateral paravertebral block using 0.3 mL/kg of 0.5% bupivacaine combined with 8 mg dexamethasone (group 1), 1 μg/kg fentanyl (group 2), or 8 mg dexamethasone + 1 μg/kg fentanyl (group 3). The study drugs were diluted with normal saline 0.9% up to 25 mL volume. The primary outcome was the time to first postoperative analgesics request, Secondary outcomes were total analgesic consumption, verbal rating pain scale (VRS) over the first 24 hours postoperatively, hemodynamic parameters, and adverse effects.. The time to first analgesic request for intravenous (IV) nalbuphine was longer in group 2 (15.75±0.9 h, P<0.001) than group 1 (10.45±1.1 h, P<0.001), while no patients requested it in group 3 (P<0.001). The total analgesic consumption of IV nalbuphine was lower in group 2 (8.6±3.5mg, P=0.04) than group 1 (11.3±2.1 mg), with a significant difference between group 2 and 3 (P<0.001). From the 8. Dexamethasone and fentanyl combination enhances the analgesic effect of bupivacaine in TPVB.

Topics: Analgesics; Anesthetics, Local; Breast Neoplasms; Bupivacaine; Dexamethasone; Double-Blind Method; Female; Fentanyl; Humans; Mastectomy; Mastectomy, Modified Radical; Nalbuphine; Pain, Postoperative; Ultrasonography, Interventional

This is a randomized controlled study aiming to evaluate the safety and efficacy of two different concentrations of topical nalbuphine hydrochloride, when used to relieve pain in the first days following photorefractive keratectomy (PRK).. This is a prospective double blinded randomized clinical trial that included 189 patients who had PRK for correction of low and moderate refractive errors. Patients were randomly assigned to three groups according to the eye drops given to relieve pain in the first three postoperative days; the first group received topical nalbuphine with a concentration of 2 mg/ml (Group A = 64 patients), the second group received topical nalbuphine in a concentration of 1 mg/ml (Group B = 69 patients) and the third group received topical artificial tears only (Group C = 56 patients).The patients were asked to rate their pain daily using a numeric rating scale and to record the number of drops instillation times/day. The time needed for complete epithelial healing, best-corrected visual acuity (BCVA) and spherical equivalent after three months were recorded in each group.. In the first three days, there was a statistically significant difference in pain score among the three groups with lower values in the two topical nalbuphine groups when compared with the control group receiving artificial tears. Moreover, the higher concentration group showed significantly lower pain score and less number of drops used /day in comparison with the lower concentration group.There were no statistically significant differences in epithelial healing time, BCVA and spherical equivalent after three months among the three groups.. The use of topical nalbuphine is effective in relieving pain in the first few days following PRK and this pain relief is not associated with any compromise regarding epithelial healing nor refractive outcome. The pain control with 2 mg/ml concentration is significantly higher than that with 1 mg/ml concentration of nalbuphine. Trial registration numberISRCTN21394752 https://doi.org/10.1186/ISRCTN21394752 The trial is retrospectively registered in ISRCTN registry at March 08, 2021.

Topics: Humans; Lasers, Excimer; Lubricant Eye Drops; Myopia; Nalbuphine; Pain, Postoperative; Photorefractive Keratectomy; Prospective Studies; Visual Acuity

Postoperative pain in elderly patients with lung cancer after thoracoscopic surgery is still an important factor affecting the prognosis of patients. In this study, 200 elderly patients with lung cancer who were positive and planned to undergo video-assisted thoracoscopic surgery were randomly divided into four groups: control group, SAPB (serratus anterior plane block) group, Nalbuphine group and Nalbuphine + SAPB group. The effects of drugs and nerve block on the perioperative indexes of elderly patients were observed. The results showed that ① The VAS and SAS scores of postoperative analgesia in the Nalbuphine + SAPB group were lower than those in the single group and the control group. ② The postoperative spontaneous respiratory recovery time, extubation time, resuscitation room stay time, extubation cough, restlessness and respiratory depression in the Nalbuphine + SAPB group were lower than those in the single group and the control group. ③ The heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and blood oxygen saturation (SpO2) of patients in Nalbuphine + SAPB group before induction, T2 after intubation, T3 before skin incision, T4 after skin incision, T5 after chest closure and T6 after extubation were lower than those in single group and control group. Therefore, this study concluded that Nabufine combined with SAPB can make the vital signs of intraoperative patients more stable, which is worthy of clinical promotion.

Topics: Aged; Humans; Lung Neoplasms; Nalbuphine; Nerve Block; Pain, Postoperative; Thoracic Surgery, Video-Assisted

Topics: Cholecystectomy; Cholecystectomy, Laparoscopic; Humans; Nalbuphine; Pain, Postoperative; Prospective Studies

Anesthesiologists are always looking for a regional analgesic technique which is easy, safe, has a low complication rate, and provides satisfactory analgesia. A retrolaminar block is a recent modified paravertebral technique for analgesia in  thoracoabdominal procedures with a local anesthetic injected at the retrolaminar site. It has the advantage of being safe and easy compared with traditional thoracic epidural analgesia but is still under investigation.. This study aimed to compare ultrasound-guided bilateral retrolaminar block with ultrasound-guided thoracic epidural analgesia for pain relief after laparoscopic cholecystectomy.. A prospective randomized double-blinded clinical study.. Academic University Hospitals.. Fifty-two adult patients were randomly allocated into 2 equal groups at the end of the surgery: Group R (n = 26) received a bilateral ultrasound-guided retrolaminar block with 20 mL of 0.25% bupivacaine and 5 µg/mL adrenaline (1:200000) in each side. Group T (n = 26) received ultrasound-guided thoracic epidural analgesia with 20 mL of 0.25% bupivacaine and 5 µg/mL adrenaline (1:200000).. The Numeric Rating Scale  scores both at rest and during cough were statistically significantly lower in Group R compared with Group T at 30 minutes and one hour postoperatively. The pain scores were statistically significantly lower for about 4 hours in Group R group compared with 6 hours in Group T. The time for the first call of nalbuphine was highly statistically significantly shorter in Group R group (233.04 ± 5.27 minutes) compared with Group T (353.77 ± 5.16 minutes) (mean difference -120.37, (95% CI,  -123.6 to -117.8) P < 0.001. The total amount of nalbuphine consumption in the first 12 hours was statistically significantly decreased in Group T (17.31 ± 5.52 mg) compared with Group R (27.69 ± 5.52 mg) (Mean difference 10.4, 95% CI  7.3-13.5), P < 0.001. The total number of patients who developed nausea and vomiting were statistically significantly greater in Group T (9 patients) compared with Group R group (3 patients), P = 0.04. Moreover, hypotension was statistically significantly more common among patients in Group T group (10 patients) compared with Group R (3 patients), P = 0.025. Both groups were comparable regarding patient satisfaction.. There is limited literature in the field of the present study and sensory dermatome assessment, but this does not affect the results as we used an ultrasound-guided technique.. A single injection retrolaminar block provides adequate postoperative pain relief for about 4 hours compared with a single shot thoracic epidural that lasts about 6 hours. Patient satisfaction with both techniques was the same; about two-thirds of the patients were satisfied or very satisfied with either block.

Topics: Adult; Analgesia, Epidural; Analgesics; Anesthetics, Local; Bupivacaine; Cholecystectomy, Laparoscopic; Epinephrine; Humans; Nalbuphine; Nerve Block; Pain, Postoperative; Prospective Studies; Ultrasonography, Interventional

The aim: To evaluate the effectiveness of erector spine plane block vs lumbar paravertebral block for early rehabilitation after total hip arthroplasty.. Materials and methods: The study included 60 ASA ІΙ-ΙΙΙ patients (female/male = 35/25) aged 41-82 years, undergone total hip arthroplasty under spinal anesthesia. The patients randomly divided into two groups (n=30 in each) according to postoperative regional analgesia technique: paravertebral block (PVB) and erector spine plane block (ESPB). The time interval to meet three criteria: adequate analgesia (<4 points of VAS), opioid-free period longer than 12 h, and possibility to cover walking 30 m distance without time restriction was analyzed. We also analyzed opioid requirement postoperatively.. Results: The time interval to meet the three criteria after surgery was shorter to 9.4 h for patients in PVB group 36.3 h 95% CI 31.8 to 40.8 h than for patients in ESPB group 45.7 h 95% CI 40.1 to 51.3 h, (p = 0.016). During the first 24 h after surgery the total dose of nalbuphine per patient was significantly higher in ESPB group (10.7 95% CI 7.0 to 14.3) compared to PVB group (6.3 95% CI 3.7 to 9.0).. Conclusions: The paravertebral block and erector spine plane block provide quite effective pain relieve in patients undergone total hip arthroplasty (<4 points of VAS). PVB has more opioid-preserving effect than ESPB. The paravertebral block is superior to erector spine plane block for early rehabilitation after total hip arthroplasty (the time required for patients to meet the three criteria was shorter PVB than ESPB).

Topics: Analgesics, Opioid; Anesthesia, Spinal; Arthroplasty, Replacement, Hip; Comparative Effectiveness Research; Female; Humans; Male; Nalbuphine; Pain, Postoperative; Paraspinal Muscles

The study will compare the efficacy and safety of nalbuphine hydrochloride injection and morphine hydrochloride injection for perioperative analgesia in tumor ablation and the differences between the two groups regarding duration of surgery, average daily dose, patient satisfaction with analgesia, quality of life, and other indicators. Furthermore, it will evaluate the clinical application of nalbuphine and morphine for perioperative analgesia in ablation surgery and provides important reference and guidance for clinical practice.. This is a randomized controlled study. Patients who were diagnosed by clinicians and required tumor ablation are enrolled and randomized to the experimental groups. In the test group, nalbuphine 80 mg + 0.9% normal saline (72 ml) is set in the patient-controlled analgesia pump, which is connected 15 min before ablation under electrocardiogram monitoring and surgery is performed immediately. The doses are as follows: initial,: 0.15 ml/kg,; background:, 0.5 ml/h,; compression:, 2 ml,; and lockout time:, 15 min. If the numeric rating scale is ≥ 4 points, the drug is administered by compression. The control group receives similar treatment under similar conditions as the test group except morphine (80 mg) is administered instead of nalbuphine (80 mg). The primary endpoints are the effective rate of analgesia and the incidence of adverse reactions (nausea and vomiting, dizziness, itching, constipation, hypoxemia, and urinary retention); the secondary endpoints are pain intensity, satisfaction with analgesia, duration of surgery, postoperative hospital stay, average daily dose, uninterrupted completion rate of surgery without complaints of pain, quality of life assessment, and vital signs.. This study, to the best of our knowledge, is the first randomized controlled trial of nalbuphine patient-controlled analgesia in ablation surgery.. U.S. Clinical Trials Network Registration No.: NCT05073744 . Registered on 11 October, 2021.

Topics: Analgesia, Patient-Controlled; Analgesics; Analgesics, Opioid; Humans; Morphine; Nalbuphine; Neoplasms; Pain, Postoperative; Quality of Life; Saline Solution

Pain management following cesarean section remains a challenge, with many puerpera suffering from severe acute postoperative pain. And for a second cesarean section the degree of uterine contraction pain is more severe and frequent than that of a primipara. This study investigated the effect of different doses of nalbuphine combined with sufentanil for postoperative analgesia in patients undergoing a second cesarean section.. We prospectively recruited 168 women with a scarred uterus undergoing elective second cesarean section and they were randomly divided into 4 groups by random number extraction. A single intravenous injection of different doses of nalbuphine was given before the intravenous drip of oxytocin, and visual analogue scale (VAS) scores of uterine contraction pain were recorded 10 minutes before intravenous infusion of oxytocin (T1) and 10 minutes (T2), 30 minutes (T3), and 60 minutes (T4) after intravenous infusion of oxytocin. At 4, 8, 12, 24, and 48 hours after patient-controlled intravenous analgesia (PCIA), pain intensity was reassessed using the VAS score.. One hundred and sixty patients underwent elective second cesarean section in between December 2020 and May 2021 completed the study. The VAS scores of uterine contractions at T1 and T4 were 3 (1.0), while the VAS scores at T2 and T3 were 7 (1.0), 6 (1.0), 5 (1.0), 5 (1.0) and 8 (1.0), 5 (2.0), 3 (1.0), 3 (0.75). The VAS scores at 12 hours after surgery of nalbuphine10mg and sufentanil (NS1), nalbuphine 10 mg and sufentanil 20 mg (NS2) and nalbuphine 30 mg and sufentanil 20 mg (NS3) were lower than sufentanil (S) group (P<0.001). Compared with the S group, total amount of sufentanil and PCIA compression numbers in the NS1, NS2, and NS3 groups at 4-8 and 8-12 hours after surgery decreased (P<0.001), with a more significant decrease in the NS2 and NS3 groups than in the NS1 group (P<0.001). The NS3 group had a significantly higher incidence of dizziness and sleepiness (P=0.02, P=0.001). Compared with the NS2 and NS3 groups, the incidence of respiratory depression in the S group was significantly higher (P=0.001).. A single intravenous injection of nalbuphine 20 mg 10 minutes before the infusion of oxytocin combined with sufentanil 2 µg/kg could be safely used for postoperative analgesia in patients undergoing a second cesarean section and could effectively inhibit uterine contractions induced by oxytocin and reduce adverse reactions.. Clinical Trial Registry ChiCTR2100042382.

Topics: Analgesia, Patient-Controlled; Cesarean Section; Double-Blind Method; Female; Humans; Nalbuphine; Oxytocin; Pain, Postoperative; Pregnancy; Sufentanil

Proximal femur fractures are most common fractures in the elderly and associated with significant mortality and morbidity, with high economic and social impact. Perioperative pain management influence outcomes and mortality after surgery with early mobilization being possible. The goal of the study was to compare the efficacy and safety of the psoas compartment block (PCB) with spinal and general anesthesia.. We included 90 patients in this randomized controlled study and divided them into three groups. For patients in group 1 ultrasound-guided PCB with bupivacaine 0.125% 6-8 ml / h was performed. Intraoperative anesthesia was provided with PCB and a sciatic nerve block. Postoperative analgesia include prolonged CPB with bupivacaine 0.125% 6-8 ml / h. In group 2 intraoperative spinal anaesthesia were performed. Group 3 patients underwent general sevoflurane inhalation anaesthesia with fentanyl infusion for analgesia. All patients received paracetamol 3 g/day and dexketoprofen 75 mg/day during hospitalization. On-demand, nalbuphine 5 mg SC was used for analgesia. Efficacy outcomes were the ICU length of stay and the total duration of hospitalization, number of patients who had severe pain after surgery, incidence of on-demand analgesia, sleep quality, postoperative mobilization time. Safety outcomes include complication incidence.. There were no differences in the duration of ICU stay - gr.1 72 [70-75], gr.2 74 [72-76], gr.3 72 [70-75] hours respectively (p = 0.29), and the total duration of hospitalization - gr.1144 [170-184], gr.2170 [148-188], gr.3178 [144-200] hours respectively. Patients in gr.1 had significantly lower nalbuphine consumption in the first 24 h after surgery and total during hospitalization (0 [0-5] mg versus 15 [10-20] and 20 [15-25] mg in the first 24 h in groups 2 and 3, respectively (p < 0.001). Gr. 1 had lower number of patients with severe pain (10% vs. 47 and 60% in groups 2 and 3, respectively, p < 0.05), lower number of on demand analgesia (0 [0-1] vs. 3 [2-4] and 4 [3, 4] in groups 2 and 3, respectively), better sleep quality (8 [7-9] vs. 6 [5-7] and 4 [3, 4] in groups 2 and 3, respectively, p < 0.001), significantly faster mobilization after surgery - sitting in bed and getting to his feet. MINS was diagnosed significantly more often in gr. 2 and 3 compared with gr. 1 (OR 9 95 CI 1,01-77, p = 0,048 for gr. 2 and OR 11 95 CI 1,2-91, p = 0, 03 for gr. 3). However, none of the patients had symptoms of myocardial ischemia and was not diagnosed with myocardial infarction. There were no difference in the incidence of nosocomial pneumonia and delirium.. Perioperative PCB in elderly patients with a proximal femur fracture could be an effective analgesia technique, as it decrease the number of patients with severe pain, need for on demand analgesia and opioid consumption. PCB also decrease the incidence of opioid-associated nausea and vomiting, comparing to general anesthesia, and increase the number of patients, who was mobilized in the 1st day (sitting) and 2nd day (getting up) after surgery. PCB may reduce the incidence of MINS, although to assess this outcome more studies are needed.. Clinicaltrials.gov: NCT04648332 , first registration date 1/12/2020.

Topics: Aged; Analgesics, Opioid; Anesthesia, General; Anesthesia, Spinal; Drug Utilization; Early Ambulation; Female; Femoral Fractures; Humans; Male; Nalbuphine; Nerve Block; Pain Measurement; Pain, Postoperative

Adjuvants to local anesthetics, such as nalbuphine and dexmedetomidine, can be used to improve the quality and duration of peripheral nerve block effects. Dexmedetomidine has been successfully used as an adjuvant of erector spinae plane block (ESPB) with ropivacaine in video-assisted thoracoscopic lobectomy surgeries (VATLS). This study aimed to compare the effects of nalbuphine and dexmedetomidine used as adjuvants to ropivacaine for ESPB in VATLS.. A total of 102 patients undergoing VATLS with ESPB were enrolled and randomized into 3 groups, each of which received a different adjuvant to ropivacaine. The visual analogue scale score, onset and duration of sensory block, use of patient-controlled analgesia (PCA), rate of rescue analgesia, duration of postoperative hospitalization, incidence of postoperative nausea and vomiting, and chronic pain were measured and observed.. The visual analogue scale score, total PCA use, rate of rescue analgesia, and postoperative chronic pain in the ropivacaine with dexmedetomidine (RD), and ropivacaine with nalbuphine (RN) groups were lower than those in the ropivacaine (RC) group (P < .05). The duration of sensory block was longer and the first use of PCA occurred later in the RD and RN groups than they did in the RC group (P < .05).. As an adjuvant to ropivacaine in ESPB, nalbuphine and dexmedetomidine are comparable in terms of the associated analgesia, sensory block duration, need for rescue analgesia, and incidence of chronic pain in patients after VATLS.

Topics: Analgesics, Non-Narcotic; Analgesics, Opioid; Anesthetics, Local; Dexmedetomidine; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Nalbuphine; Nerve Block; Pain, Postoperative; Paraspinal Muscles; Peripheral Nerves; Pneumonectomy; Ropivacaine; Thoracic Surgery, Video-Assisted; Treatment Outcome; Ultrasonography, Interventional

BACKGROUND The goal of this study was to investigate different doses of nalbuphine combined with dexmedetomidine in the postoperative treatment of laparoscopic oophorocystectomy. MATERIAL AND METHODS This prospective single-blinded randomized controlled study included 219 patients with benign ovarian cysts who received laparoscopic oophorocystectomy from March 2017 to October 2019. Patients were randomized into 4 groups: low (0.5 mg/kg), middle (1.0 mg/kg), and high (1.5 mg/kg) doses of nalbuphine combined with dexmedetomidine (4 μg/kg) (LND, MND, and HND groups, respectively) and a control group with sufentanil (2.5 μg/kg), with different patient-controlled intravenous analgesia pump (PCIA) strategies. Rest and active visual analog scale (VAS) scores measured postoperative pain, and Ramsay scores were used to measure sedation. RESULTS The HND group showed the lowest rest and cough VAS scores at 2 h, 8 h, 12 h, and 24 h after surgery, the lowest PCIA pressing time within 48 h after surgery, and the highest Ramsay scores at 2 h, 8 h, 24 h and 48 h after surgery. Rest and cough VAS scores decreased with higher nalbuphine doses in a dose-dependent manner. One day after surgery, IL-1ß and IL-6 levels increased in all groups, with the lowest levels of IL-1ß and IL-6 in the HND group. Hospitalization time was significantly shorter in the HND group compared with the LND and MND groups. There were no significant differences in complications among groups. CONCLUSIONS Combined nalbuphine and dexmedetomidine improved postoperative pain and sedative conditions, reduced inflammation in a nalbuphine dose-dependent manner, and might facilitate patient recovery.

Topics: Adult; Analgesics; Biomarkers; Clinical Decision-Making; Dexmedetomidine; Disease Management; Female; Hospitalization; Humans; Laparoscopy; Middle Aged; Nalbuphine; Ovariectomy; Pain Management; Pain Measurement; Pain, Postoperative; Treatment Outcome

Postoperative pain is a negative factor that seriously affects a surgical patient's rehabilitation. We investigated whether nalbuphine provides superior postoperative analgesia in orthognathic surgery compared with sufentanil and whether the superior analgesia is achieved by the regulation of inflammatory and oxidative stress.. In the present randomized, double-blind, controlled clinical trial, 60 patients scheduled to undergo orthognathic surgery were randomized to receive 2.5 μg/kg of sufentanil (group S) or 2 mg/kg of nalbuphine (group N) for postoperative controlled intravenous analgesia. The primary outcome variable was the visual analog scale (VAS) score. The secondary outcome variables included the sedation score (Ramsay score) and plasma levels of inflammation factors, including tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6), and oxidant stress factors, including malondialdehyde (MDA) and superoxide dismutase (SOD).. The VAS scores of group N were significantly lower than those of group S, and the Ramsay scores for group N were greater. The plasma levels of TNF-α, IL-6, and MDA for group N were significantly lower than those for group S, and the SOD levels were greater than those for group S. Furthermore, the VAS scores correlated positively with the plasma levels of TNF-α, IL-6, and MDA and correlated negatively with the SOD levels.. Nalbuphine offers better postoperative analgesia and sedation after orthognathic surgery. Nalbuphine also seems to provide superior postoperative analgesia by reducing inflammatory and oxidative stress.

Topics: Analgesia; Analgesia, Patient-Controlled; Analgesics, Opioid; Double-Blind Method; Humans; Nalbuphine; Orthognathic Surgery; Oxidative Stress; Pain, Postoperative; Sufentanil

Nalbuphine has been suggested to be used for post-cesarean section (CS) intravenous analgesia. However, ideal concentration of nalbuphine for such analgesia remains unclear. The present study was conducted to explore an ideal concentration of nalbuphine for post-CS intravenous analgesia by evaluating the analgesic effects and side-effects of three different concentrations of nalbuphine combined with hydromorphone for post-CS intravenous analgesia in healthy parturients.. One-hundred-and-fourteen parturients undergoing elective CS were randomly allocated to one of three groups (38 subjects per group) according to an Excel-generated random number sheet to receive hydromorphone 0.05 mg/mL + nalbuphine 0.5 mg/mL (group LN), hydromorphone 0.05 mg/mL + nalbuphine 0.7 mg/mL (group MN), and hydromorphone 0.05 mg/mL + nalbuphine 0.9 mg/mL (group HN) using patient-controlled analgesia (PCA) pump. Visual analog scale (VAS) for pain, PCA bolus demands, cumulative PCA dose, satisfaction score, Ramsay score, and side-effects such as urinary retention were recorded.. The number of PCA bolus demands and cumulative PCA dose during the first 48 h after CS were significantly higher in group LN (21 ± 16 bolus, 129 ± 25 mL) than those in group MN (15 ± 10 bolus, 120 ± 16 mL) (both P < 0.05) and group HN (13 ± 9 bolus, 117 ± 13 mL) (both P < 0.01), but no difference was found between group HN and group MN (both P > 0.05). VAS scores were significantly lower in group HN than those in group MN and group LN for uterine cramping pain at rest and after breast-feeding within 12 h after CS (all P < 0.01) and VAS scores were significantly higher in group LN than those in group MN and group HN when oxytocin was intravenously infused within 3 days after CS (all P < 0.05), whereas VAS scores were not statistically different among groups for incisional pain (all P > 0.05). Ramsay sedation scale score in group HN was significantly higher than that in group MN at 8 and 12 h after CS (all P < 0.01) and group LN at 4, 8, 12, 24 h after CS (all P < 0.05).. Hydromorphone 0.05 mg/mL + nalbuphine 0.7 mg/mL for intravenous PCA could effectively improve the incisional pain and uterine cramping pain management and improve comfort in patients after CS.. ChiCTR1800015014, http://www.chictr.org.cn/ Chinese Clinical Trial Registry.

Topics: Adult; Analgesia, Patient-Controlled; Cesarean Section; Female; Humans; Hydromorphone; Nalbuphine; Pain, Postoperative; Patient Satisfaction; Pregnancy; Visual Analog Scale

To evaluate the 95% effective dose of nalbuphine in patient-controlled intravenous analgesia (PCIA) by the sequential method and compare the analgesia efficacy with the equivalent dose of sufentanil on patients undergoing laparoscopic total hysterectomy.. In the first part, we defined a successful analgesia as the highest VAS ≤3 in 24 hours postoperatively. On the contrary, a failed analgesia was the highest VAS>3. According to the last patient's outcome, the next patients would be given an increase or decreased dose grade. This process ended up with 9 cross-over points. In the second part, 60 patients undergoing laparoscopic total hysterectomy were selected. They were randomly divided into 2 groups (n = 30 each group): receiving sufentanil 1.78 μg/kg (group S) and nalbuphine 1.78 mg/kg (group N). PCIA pump was given at the end of the operation with 5 mL bonus loading. The total amount of PCIA was 100 mL and programmed to deliver 0.5 mL each time with a lockout interval of 15 minutes and the background infusion amount of 2 mL/h. The VAS score and Ramsay score of were collected after the operation, the number of effective pressing times of PCIA were also recorded. Adverse reactions were documented in detail.. The 95% effective dose of nalbuphine in PCIA on patients undergoing laparoscopic total hysterectomy was 1.78 mg/kg. There was no significant difference in VAS between the sufentanil group and the nalbuphine groups (P > .05), but the number of the use of PCIA in the group S was more than that in the group N obviously (P <.05). The group S has a lower ramsay sedation score than group N at every time point. (P <.05). The incidence of nausea and vomiting was not statistically significant differences between two groups in the first 24 hours after colonoscopy (P >  q .05).. Nalbuphine 1.78 mg/kg in PCIA is recommended for the patients undergoing laparoscopic total hysterectomy. And nalbuphine is a reasonable alternative to sufentanil when used in PCIA.

Topics: Administration, Intravenous; Analgesia, Patient-Controlled; Analgesics, Opioid; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Hysterectomy; Laparoscopy; Middle Aged; Nalbuphine; Pain, Postoperative; Sufentanil

Postoperative pain in ambulatory surgery is a multifactorial issue affecting patient satisfaction, time of discharge, and rehospitalization. This study evaluated the efficacy and safety of nalbuphine for the treatment of postoperative pain after ambulatory surgery, relative to tramadol.. This multi-center, randomized, double blind, and controlled study was conducted at 10 centers. In accordance with the inclusion criteria, 492 ambulatory surgery patients were recruited. These patients had moderate to severe pain after ambulatory surgery, with a visual analogue scale (VAS) score > 3 cm. They were randomly divided into an experimental (n = 248) or control (n = 244) group and treated for analgesia with 0.2 mg/kg of nalbuphine or 2 mg/kg of tramadol, respectively. VAS scores, adverse events, and vital signs of the patients were recorded before administration (baseline; T. The VAS scores of the experimental and control groups were statistically comparable at timepoints T. Nalbuphine can provide effective and safe pain relief in patients after ambulatory surgery.. The registration number is ChiCTR-IOR-16010032 , the date of registration was 2016-11-28.

Topics: Adult; Ambulatory Surgical Procedures; Analgesics, Opioid; Double-Blind Method; Female; Humans; Male; Middle Aged; Nalbuphine; Pain Management; Pain, Postoperative; Postoperative Nausea and Vomiting; Prospective Studies; Tramadol

To evaluate the effects of nalbuphine, butorphanol and morphine combined with acepromazine on intraoperative and early postoperative pain management in dogs anesthetized for ovariohysterectomy.. Prospective, randomized blinded clinical study.. A total of 48 healthy female dogs of different breeds, aged 1-6 years, weighing (mean ± standard deviation) 14.5 ± 4.8 kg.. Dogs were randomly assigned into four groups to be intravenously administered nalbuphine (0.5 mg kg. At the left ovarian pedicle ligation, HR was higher in N1.0 than in B0.4 (p = 0.020). RT decreased significantly by the end of surgery in N0.5 (p = 0.043) and B0.4 (p = 0.010). Rescue analgesia was administered postoperatively over 6 hours to eight, seven, nine and 10 dogs in N0.5, N1.0, B0.4 and M0.2, respectively (p = 0.57). DIVAS II was higher in B0.4 than in N1.0 at 2 and 3 hours (p = 0.038 and p = 0.002, respectively) and N0.5 at 3 hours (p = 0.003).. At the doses used, all premedication protocols provided insufficient intraoperative analgesia, with minimal clinical differences between groups. No premedication provided satisfactory analgesia in the first 6 hours postoperatively.

Topics: Analgesics, Opioid; Animals; Butorphanol; Dogs; Female; Hysterectomy; Morphine; Nalbuphine; Ovariectomy; Pain, Postoperative; Prospective Studies; Single-Blind Method

A long-acting prodrug of nalbuphine, nalbuphine sebacate, has been developed for meeting the unmet medical need of long-acting analgesics. Naldebain. A total of 110 patients will be recruited and randomized into two treatment groups. Group 1 receives a single dose of Naldebain. Post-laparotomy pain can have a harmful effect on patient recovery; therefore, a slow-release formulation that can cover at least 7 days of analgesic effect is required. This study will demonstrate whether a single use of Naldebain. NCT03296488 .

Topics: Adult; Aged; Aged, 80 and over; Analgesia, Patient-Controlled; Analgesics, Opioid; Data Interpretation, Statistical; Female; Fentanyl; Humans; Laparotomy; Male; Middle Aged; Nalbuphine; Pain, Postoperative; Randomized Controlled Trials as Topic; Research Design

To assess different doses of nalbuphine with flurbiprofen compared to sufentanil with flurbiprofen in multimodal analgesia efficacy for elderly patients undergoing gastrointestinal surgery with a transverse abdominis plane block (TAPB).. 158 elderly patients scheduling for elective open gastrointestinal surgery under general anesthesia and TAPB were randomly assigned to four groups according to different doses of nalbuphine with flurbiprofen in postoperative intravenous analgesia (PCIA). Postoperative pain intensity, effective pressing numbers of PCIA, and adverse effects were recorded at 6, 12, 24, and 48 hours after surgery.. Postoperative pain intensity, effective pressing numbers, and the incidence of postoperative nausea and vomiting (PONV) were similar among the four groups after surgery, while the severity of PONV was decreased in Group L compared with Group S at 6, 12, and 48 h after surgery. No individual experienced pruritus, respiratory depression, or hypotension.. Low dose of nalbuphine (15 

Topics: Abdominal Muscles; Aged; Aged, 80 and over; Analgesics; Digestive System Surgical Procedures; Double-Blind Method; Female; Flurbiprofen; Gastrointestinal Diseases; Humans; Male; Nalbuphine; Nerve Block; Pain Measurement; Pain, Postoperative; Statistics, Nonparametric; Treatment Outcome

Topics: Abortion, Induced; Adult; Ambulatory Care; Analgesics, Opioid; Anesthesia, General; Dose-Response Relationship, Drug; Double-Blind Method; Feasibility Studies; Female; Humans; Male; Nalbuphine; Pain Measurement; Pain, Postoperative; Pregnancy; Propofol; Prospective Studies; Sufentanil; Treatment Outcome; Young Adult

This study was conducted to evaluate the safety and efficacy of single sebacoyl dinalbuphine ester (SDE) injection (150 mg/2 mL) when administered intramuscularly to patients who underwent hemorrhoidectomy for postoperative long-acting analgesia.. A total of 221 patients scheduled for hemorrhoidectomy from 6 centers in Taiwan were randomly divided into SDE group and placebo group, and received the treatment, vehicle or SDE, 1 day before the surgery. Visual analogue scale (VAS) was recorded up to 7 to 10 days. Pain intensity using VAS AUC through 48 hours after surgery was calculated as the primary efficacy endpoint.. Area under the curve of VAS pain intensity scores (VAS AUC) through 48 hours after hemorrhoidectomy was significantly less in SDE group than those in placebo group (209.93 vs. 253.53). VAS AUC from the end of surgical procedure to day 7 was also significantly different between SDE and placebo group (630.79 vs. 749.94). SDE group consumed significantly less amount of other analgesics, such as PCA ketorolac and oral ketorolac. Median time from the end of surgery to the first use of pain relief medication was also shortened in the placebo group than in the SDE group. Most adverse events were assessed as mild and tolerable in both groups.. SDE injection demonstrated an extended analgesia effect, with a statistically significant reduction in pain intensity through 48 hours and 7 days after hemorrhoidectomy.

Topics: Adult; Analgesics, Opioid; Area Under Curve; Delayed-Action Preparations; Double-Blind Method; Female; Hemorrhoidectomy; Humans; Injections, Intramuscular; Male; Nalbuphine; Pain Measurement; Pain, Postoperative; Patient Satisfaction; Preoperative Care; Taiwan; Treatment Outcome

To evaluate the effectiveness of inducing acute hypertension during laparoscopic\ ovarian cystectomy on postoperative nalbuphine analgesic requirements.. The total dose of nalbuphine used in the hypertension group was significantly lower\ than that in the control group (p <0.001). The VAS score was significantly lower in the hypertension\ group on arrival to PACU and during the period between 1 and 6 hours postoperatively.. This study demonstrates that pharmacologically induced mild acute\ intraoperative hypertension significantly reduces postoperative nalbuphine consumption and pain\ scores following laparoscopic ovarian cystectomy. Trial registration in Pan African Clinical Trial\ Registry: identification number for the registry is PACTR201508001247179.

Topics: Acute Disease; Adult; Double-Blind Method; Female; Humans; Hypertension; Laparoscopy; Middle Aged; Nalbuphine; Ovarian Cysts; Pain, Postoperative

The objective of this study was to investigate the pharmacokinetics and effect of nalbuphine administered intravenously to calves immediately prior to surgical castration. Ten healthy calves were randomly assigned to two treatments (n = 5): (i) 0.9% sodium chloride (CONT) placebo, (ii) nalbuphine hydrochloride (NAL) (0.4 mg/kg). Blood samples collected over 10 h postcastration were analyzed for nalbuphine and cortisol concentrations. Additionally, heart rate, respiratory rate, rectal temperature, and step count was compared between groups using a random-effects mixed model. Changes in behavior and attitude were assessed using a six-point ordinal scoring system and compared using chi-square analysis. Plasma NAL concentrations were only detectable for 3 h postadministration (T½ = 0.68 h; Range: 0.53-0.79 h). There was no effect of NAL treatment prior to castration on cortisol concentrations (P = 0.99), heart rate (P = 0.73), respiratory rate (P = 0.59), rectal temperature (P = 0.22), and step count (P = 0.08) but fewer calves showed signs of head shaking, kicking, and tail flicking in the NAL group compared with the CONT group (P = 0.036). Therefore, we conclude that a single intravenous injection of nalbuphine at 0.4 mg/kg reduced some pain-related behaviors but did not significantly eliminate the physiological signs of distress in calves after surgical castration.

Topics: Analgesics, Opioid; Animals; Cattle; Cattle Diseases; Male; Nalbuphine; Orchiectomy; Pain, Postoperative

To measure the change in the minimum alveolar concentration of isoflurane (EtISO) associated with epidural nalbuphine and the postoperative analgesic requirements in dogs after ovariohysterectomy.. Twenty four healthy female dogs were randomly assigned to receive saline or nalbuphine at 0.3 or 0.6 mg/kg (n=8 for each group) administered via lumbosacral epidural catheter introduced cranially into the epidural canal. Changes in heart and respiratory rates and arterial blood pressure during surgery were recorded along with the corresponding EtISO. Immediately after tracheal extubation, analgesia, sedation, heart rate, respiratory rate, and arterial blood pressure were measured at predetermined intervals and every 60 min thereafter until the first rescue analgesic.. A significant decrease in EtISO was associated with epidural nalbuphine at 0.3 mg/kg (26.3%) and 0.6 mg/kg (38.4%) but not with saline in ovariohysterectomized dogs. In the postoperative period, VAS and Colorado analgesic scores were lower for the dogs that received the higher nalbuphine dose, which only required supplemental analgesia 10 h following its administration, compared with dogs that received the lower dose.. Epidural nalbuphine significantly reduces the intra-operative isoflurane requirement and provides prolonged postoperative analgesia after ovariohysterectomy in dogs.

Topics: Analgesia, Epidural; Analgesics, Opioid; Anesthesia, Epidural; Animals; Dogs; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Hysterectomy; Isoflurane; Nalbuphine; Ovariectomy; Pain Measurement; Pain, Postoperative; Postoperative Period; Time Factors

Epidural morphine in patient-controlled analgesia regimens controls postoperative pain well but easily induces pruritus and other epidural morphine-related side effects. With 90 pregnant American Society of Anesthesiologists physical status II females scheduled for elective cesarean delivery, the present study was designed to evaluate the efficacy and safety profile of patient-controlled antipruritus (PCP) use of intravenous nalbuphine-based regimens for attenuation of postoperative pruritus and related side effects in combination with epidural morphine patient-controlled analgesia with regard to the quality of postoperative pain management. Patients were randomly assigned to two nalbuphine groups (5 μg/kg/hour, Group N5 or 10 μg/kg/hour, Group N10) and bolus dose of 1.6 μg/kg for PCP or the control (normal saline) group. Comparable visual analog scale scores for rest pain at each measured time interval among the three groups demonstrated that adequate pain relief was offered; however, the cumulative dose of nalbuphine administered to the patients in Group N10 attenuated the analgesic effect of epidural morphine in moving pain at POh24 only. Fewer episodes and milder severity of pruritus were observed in patients in Groups N5 and N10 at all postoperative time intervals. Epidural morphine provided good postoperative pain relief but with incommodious side effects. In addition, intravenous nalbuphine not only attenuated the incidence of pruritus but also decreased total morphine consumption. In conclusion, intravenous administration of low-dose nalbuphine (5 μg/kg/hour) for PCP maintained analgesia produced by epidural morphine and offered low pruritus incidence.

Topics: Adult; Analgesia, Epidural; Analgesia, Patient-Controlled; Cesarean Section; Demography; Dose-Response Relationship, Drug; Female; Humans; Injections, Intravenous; Morphine; Nalbuphine; Pain Measurement; Pain, Postoperative; Pregnancy; Pruritus; Young Adult

It is suggested that topical application of opioids may provide localized analgesia without delay in corneal wound healing. This study was designed to evaluate the effect of topical application of 0.8% nalbuphine on post-operative ocular pain in dogs. Twelve eyes from 11 dogs undergoing phacoemulsification cataract surgery were divided into a nalbuphine group (n=6) and saline group (n=6). Postoperatively, the nalbuphine group received 0.1 ml of topical 0.8% alkalinized nalbuphine (pH 5.6) every 8 hr, and the saline group received 0.1 ml of topical saline (pH 5.9) as a placebo. All dogs received systemic postoperative pain managements with oral tramadol (4 mg/kg) and prednisolone (0.5 mg/kg) every 8 hr. All dogs received pre- and post-ophthalmic examinations. Pain was scored in the dogs using a pain scoring system modified from the University of Melbourne pain scale at 15, 30 and 60 min following the topical treatment on days 1 and 2 (24 and 48 hr after surgery). Eye blink frequency and corneal touch threshold (CTT) were recorded at the same time. There was no statistical difference in the pain score between groups. Significant decreases in CTT, blepharospasm and eye blink frequency were observed after the topical nalbuphine treatment. This indicated that topical application of 0.8% nalbuphine solution can produce a rapid reduction of corneal discomfort in dogs.

Topics: Administration, Topical; Animals; Dogs; Nalbuphine; Pain, Postoperative; Phacoemulsification; Prednisolone; Statistics, Nonparametric; Time Factors; Tramadol

The addition of ultra-low-dose naloxone to patient-controlled analgesia (PCA) with morphine reduces opioid-related side effects. Nalbuphine, a mixed opioid agonist-antagonist, may be able to attenuate opioid-related side effects. The goal of the present study was to investigate the effect of combined low-dose nalbuphine and morphine in PCA for postoperative pain control after gynecological surgery.. This randomized, double-blind, controlled study enrolled 174 female patients who were undergoing total abdominal hysterectomy, myomectomy, or ovarian tumor excision. In the control group, the PCA formula was 1 mg/mL pure morphine. In the study group, the PCA formula was 1 mg/mL morphine and 10 microg/mL nalbuphine (1:100). Numerical rating score, PCA requirement, nausea, vomiting, use of antiemetics, pruritus, use of antipruritics, and opioid-related adverse events were investigated at 1, 2, 4, and 24 hours postoperatively.. One hundred and sixty-nine patients completed the study: 86 in the control group and 83 in the study group. The incidence of nausea was lower in the study group (41%) than in the control group (65%). The incidence of vomiting, use of antiemetics, pruritus, and use of antipruritics did not differ between the two groups. The numerical rating pain score and PCA requirements were not significantly different between the two groups.. Combination of low-dose nalbuphine and morphine in PCA decreases the incidence of opioid-related nausea, without affecting the analgesia and PCA requirement. This novel combination can improve the quality of PCA used for postoperative pain control after gynecological surgery.

Topics: Adolescent; Adult; Aged; Analgesia, Patient-Controlled; Analgesics, Opioid; Double-Blind Method; Female; Humans; Middle Aged; Morphine; Nalbuphine; Pain, Postoperative

Nalbuphine and tramadol are potent analgesic drugs. Our aim was to preliminarily assess and compare the efficacy and safety of nalbuphine and tramadol for postoperative analgesia in children. In a double-blind design, 24 ASA 1-3 children aged 1 to 10 years undergoing a scheduled surgical procedure were randomly allocated to receive either an intravenous bolus dose of nalbuphine 100 microg/kg immediately before the end of surgery followed by an infusion of 0.2 microg/kg/min for 72 hrs., or an intravenous bolus dose of tramadol 1000 microg/kg followed by an infusion of 2.0 microg/kg/min for 72 hrs. Postoperative pain control and drug-related adverse events were recorded. Three children who received nalbuphine required an extra bolus dose within the 12 hrs. of post-surgery versus one child in the tramadol group. A similar number of patients in both groups required an increment in the infusion rate within the 72 post-surgery hours. Sedation was observed in 2 children in the nalbuphine group and in 1 child in the tramadol group. Four children presented vomiting with tramadol and two with nalbuphine. Cardiovascular parameters remained within the normal ranges in both groups. In conclusion, the bolus/infusion regimen of tramadol evaluated in this study appears to have better postoperative analgesic efficacy than the bolus/infusion regimen of nalbuphine. These preliminary results require further confirmation by studies with a sample size enough to clearly identify differences in their efficacy as well as in the rate of adverse events secondary to the administration of each of them.

Topics: Analgesics, Opioid; Child; Child, Preschool; Dose-Response Relationship, Drug; Female; Follow-Up Studies; Humans; Infant; Infusions, Intravenous; Male; Nalbuphine; Pain Measurement; Pain, Postoperative; Pilot Projects; Tramadol; Treatment Outcome

To evaluate the degree of postoperative pain in dogs undergoing elective castration or ovariohysterectomy (OHE); determine whether an association exists between surgeon experience, incision length, or surgery duration and degree of postoperative pain; and determine whether analgesic treatment decreases expression of postoperative pain behaviors.. Randomized controlled clinical trial.. 426 client-owned dogs undergoing OHE or castration.. Dogs underwent OHE or castration performed by an experienced veterinarian or a fourth-year veterinary student. Dogs were randomly assigned to 1 of 4 treatment groups: no perioperative analgesic treatment (n = 44), preoperative administration of morphine (144), preoperative administration of nalbuphine (119), and postoperative administration of ketoprofen (119). Dogs were evaluated while in the hospital before anesthesia and for 4 hours after surgery and once a day at home for 3 days after surgery.. Dogs in all 4 groups had significant increases in overall pain scores after surgery, compared with baseline scores. There were significant differences among groups, with control dogs having significantly higher increases in overall pain scores than dogs in the other groups. Factors that did not influence the frequency or severity of pain-related behaviors included breed, individual hospital, anesthetic induction protocol, surgeon experience, and duration of surgery.. Results suggested that dogs expressed behaviors suggestive of pain following OHE and castration, that analgesic treatment mitigated the expression of pain-related behaviors, and that surgeon experience and surgery duration did not have any effect on expression of pain-related behaviors.

Topics: Analgesia; Animals; Behavior, Animal; Dogs; Female; Hysterectomy; Ketoprofen; Male; Morphine; Nalbuphine; Orchiectomy; Ovariectomy; Pain Measurement; Pain, Postoperative; Postoperative Care; Preoperative Care; Time Factors

Nalbuphine, a mixed agonist-antagonist opioid, has a potential to attenuate the mu-opioid effects and to enhance the kappa-opioid effects. However, when morphine and nalbuphine are mixed together, the clinical interactions in different combining ratios on analgesic effect and adverse events are unknown.. This randomized, double-blind controlled study investigated five different combining ratios of morphine and nalbuphine in 311 patients undergoing gynaecologic operations. The concentrations [morphine (mg ml(-1))]/[nalbuphine (mg ml(-1))] were 1/0 in Group 1, 0.75/0.25 (ratio 1:3) in Group 2, 0.5/0.5 (ratio 1:1) in Group 3, 0.25/0.75 (ratio 3:1) in Group 4, and 0/1 in Group 5. Patient-controlled analgesia (PCA) requirement, postoperative pain, and adverse events were evaluated throughout the postoperative 24 h period.. Twenty-four hour PCA requirements were similar among the five groups. Verbal rating scores for pain were statistically higher in Groups 2 and 4 than in Group 3. The incidences of pruritus were higher in Group 1 (15.6%) than in Group 2 (6.2%), Group 3 (3.4%), Group 4 (1.6%), and Group 5 (0%). The incidences and severity of dizziness, nausea, and vomiting were not significantly different.. The interaction between morphine and nalbuphine in PCA admixture on analgesia is additive. Combinations of morphine and nalbuphine in PCA can decrease the incidence of pruritus, and the antipruritus effect is ratio-dependent. This may provide a novel combination strategy of opioid agonist and agonist-antagonist for postoperative pain management after gynaecologic surgery.

Topics: Adolescent; Adult; Aged; Analgesia, Patient-Controlled; Analgesics, Opioid; Antiemetics; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Humans; Infusions, Intravenous; Middle Aged; Morphine; Nalbuphine; Pain Measurement; Pain, Postoperative; Postoperative Nausea and Vomiting

We develop a mechanistic model for post-operative pain and apply it to describe the pharmacodynamic effects of the kappa-opioids nalbuphine and naloxone administered either alone or in combination in patients after surgical removal of one or more madibular third molar teeth. Data were obtained from 6 clinical studies in which a total of 304 patients were intravenously administered single doses of 2.5, 5, 10 or 20 mg of nalbuphine. Some groups also received 0.2 or 0.4 mg of naloxone. A total of 3,040 Visual analog scale (VAS) pain ratings were recorded at 20 min intervals for 3 h after drug administration. We used a two-site indirect action model to describe early and late pain and to incorporate the effect of nalbuphine and naloxone on pain over time. A mixed effects statistical model was used to account for inter- and intra-individual variability. Our model estimated the population average baseline pain score in men to be lower than that in women (68 vs. 76 mm on the 100 mm VAS scale). The model confirmed a late increase in pain (anti-analgesia) and estimated the lag time for the start of anti-analgesia to be 73 min after study drug administration. The maximum early phase pain score is 81.6 mm while the maximum anti-analgesia is 16.1 mm. The nalbuphine dose required to reduce early pain by 50% (ED(50)) was estimated to be 5.85 mg and the naloxone dose required to reduce late phase pain by 50% was estimated to be 0.5 mg. The model confirmed the results from conventional statistical analyses performed previously on individual studies.

Topics: Double-Blind Method; Female; Humans; Male; Models, Chemical; Models, Statistical; Nalbuphine; Naloxone; Pain, Postoperative; Sex Characteristics

The purpose of this series was to explore a 12.5:1 fixed-dose ratio of an intravenous nalbuphine and naloxone mixture (NNM) for use in patients following gynecologic surgery.. Open-label, nonrandomized case series. The first series was a dose-ranging investigation for 12 patients following elective total abdominal hysterectomy or myomectomy. In this series, fentanyl was used for intraoperative analgesia, and patients were assigned to a lower NNM (2.5 mg/0.2 mg) or to a higher NNM (5 mg/0.4 mg) dose group. The second series evaluated the fixed dose of 5 mg nalbuphine/0.4 mg naloxone for four patients undergoing ambulatory gynecologic procedures. In the second series, no opioid agents were administered intraoperatively to eliminate the possibility of mu-opioid reversal by naloxone postoperatively.. Pain control was assessed using a Verbal Pain Scale (0-10). Vital signs, side effects, and adverse events were recorded to determine drug safety.. In the first series, there were no adverse events; however, each patient required rescue medication (either morphine or fentanyl). In the second series, two of the four patients reported a reduction in pain following drug administration and did not require any further analgesic agents in the 3-hour postoperative period. One patient had an asymptomatic lowering of heart rate after receiving the drug.. Additional research of the unique combination therapy of nalbuphine and naloxone is warranted to further determine its potential clinical efficacy and safety.

Topics: Adult; Analgesics; Dose-Response Relationship, Drug; Drug Combinations; Female; Gynecologic Surgical Procedures; Humans; Infusions, Intravenous; Middle Aged; Nalbuphine; Naloxone; Pain, Postoperative

To evaluate the role of sigma receptors in the sexually dimorphic antianalgesic effect of agonist-antagonist kappa opioids, 2 neuroleptics, haloperidol, a sigma receptor antagonist, and chlorpromazine, which has minimal effect at sigma receptors, were administered with the agonist-antagonist kappa opioid nalbuphine in patients with postoperative pain. Before surgical extraction of bony impacted mandibular third molar teeth, patients received haloperidol (1 mg), chlorpromazine (10 mg), or placebo by oral administration. After surgery, the pain intensity did not differ significantly between the 3 treatment groups, suggesting lack of analgesic effect produced by either haloperidol or chlorpromazine. All patients were then administered nalbuphine (5 mg, intravenous). As previously reported, the group that did not receive a preoperative neuroleptic exhibited sexually dimorphic analgesia, with women experiencing greater analgesia than men. Antianalgesia was also observed, with men experiencing late onset increased pain compared with baseline, starting approximately 1 hour after nalbuphine administration. Both neuroleptics blocked nalbuphine antianalgesia, resulting in enhanced analgesia and elimination of the sex differences. Because chlorpromazine and haloperidol enhanced nalbuphine analgesia and eliminated sexual dimorphism, the receptor at which neuroleptics act to antagonize the "antianalgesia" might be a common site of action to both drugs.. This study demonstrates that neuroleptics can block the antianalgesic effect of agonist-antagonist kappa opioids. These findings could help inform the development of novel analgesics.

Topics: Analgesics, Opioid; Chlorpromazine; Drug Therapy, Combination; Female; Haloperidol; Humans; Male; Nalbuphine; Narcotic Antagonists; Pain Measurement; Pain, Postoperative; Sex Factors; Tooth Extraction

Intramuscular (i.m.) tramadol increases gastric pH during anaesthesia similar to famotidine. We investigated the antacid analgesic value of a single dose of i.m. tramadol given 1 h before elective Caesarean section performed under general anaesthesia.. Sixty ASA I parturients undergoing elective Caesarean section were included in a randomized double-blind study. The patients were randomly allocated to receive i.m. tramadol 100 mg (n=30) or famotidine 20 mg (n=30) 1 h before general anaesthesia.. At the beginning and the end of anaesthesia, patients receiving tramadol had a median gastric fluid pH of 6.4, which was not significantly different from those treated with famotidine (median 6.3). The infant well-being, as judged by Apgar score, cord blood gas analysis, and neurobehavioural assessment showed no significant difference between the two groups. Nalbuphine consumption in the first 24 h after operation was reduced by 35% in the tramadol group. Pain intensity score on sitting and sedation were significantly greater in famotidine group up to 24 h after surgery. There was no significant difference in incidence and severity of nausea and vomiting between the two groups.. A single i.m. dose of tramadol is useful pre-treatment to minimize the risk of acid aspiration during operation, and in improving pain relief during 24 h after surgery.

Topics: Adult; Analgesics, Opioid; Anesthesia, General; Anesthesia, Obstetrical; Antacids; Anti-Ulcer Agents; Cesarean Section; Double-Blind Method; Drug Administration Schedule; Famotidine; Female; Gastric Acidity Determination; Humans; Hydrogen-Ion Concentration; Intraoperative Complications; Nalbuphine; Pain, Postoperative; Pneumonia, Aspiration; Preanesthetic Medication; Pregnancy; Pregnancy Outcome; Tramadol

In recent studies we demonstrated that the analgesic effect of the kappa-like opioids is significantly greater in women, that low dose nalbuphine (5 mg) produces profound anti-analgesia (i.e. enhances pain) in men, and that addition of a low dose of the non-selective opioid receptor antagonist naloxone (0.4 mg) to nalbuphine (5 mg) abolishes the sex difference and results in significantly enhanced analgesia in both sexes. To further delineate the dose-dependent analgesic and anti-analgesic effects of nalbuphine, the present study evaluated the effect of a lower dose of nalbuphine (2.5 mg), with and without naloxone, on dental postoperative pain. In women, nalbuphine alone induced modest, short duration analgesia, which was antagonized rather than enhanced by the addition of naloxone (0.4 mg). In men, this dose of nalbuphine alone did not produce analgesia or anti-analgesia, and naloxone (0.4 mg) did not alter the response to nalbuphine. Thus, the anti-analgesic effect of nalbuphine, present in both sexes at the 5 mg dose disappears at the lower dose of nalbuphine. In addition, the mild analgesia in women produced by this lower dose of nalbuphine is antagonized by naloxone.

Topics: Adult; Analgesics, Opioid; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Humans; Male; Nalbuphine; Naloxone; Pain, Postoperative; Receptors, Opioid, kappa; Sex Factors; Tooth Extraction

In this prospective, randomized, double-blinded study, we compared the prophylactic efficacy of nalbuphine and ondansetron for the prevention of intrathecal morphine-induced pruritus after cesarean delivery. Two-hundred-forty parturients were randomly allocated into four groups. The N-4 group, O-4 group, O-8 group, and placebo group received IV 4 mg of nalbuphine, 4 mg of ondansetron, 8 mg of ondansetron, and 4 mL of normal saline, respectively, immediately after the baby was delivered. In the postanesthesia care unit, we found that the severity of pruritus score in the four groups was significantly different (P < 0.001). The prophylactic success rate for pruritus of the N-4, O-4, O-8, and placebo groups was 20%, 13%, 12%, and 6%, respectively (P < 0.001). The pruritus score between N-4 and placebo and O-4 and placebo was significantly different (P < 0.001 and P = 0.006, respectively). Treatment for pruritus was requested by patients in 25%, 47%, 51%, and 72% of patients in the N-4, O-4, O-8, and placebo groups, respectively (P < 0.001). There were no differences among groups in nausea/vomiting score, pain score, sedation score, or shivering score at 4, 8, and 24 h after surgery. Nalbuphine and ondansetron are more effective than placebo for the prevention of intrathecal morphine-induced pruritus after cesarean delivery.. Nalbuphine and ondansetron are more effective than placebo for the prevention of intrathecal morphine-induced pruritus after cesarean delivery.

Topics: Adult; Analgesics, Opioid; Cesarean Section; Double-Blind Method; Female; Humans; Morphine; Nalbuphine; Narcotic Antagonists; Ondansetron; Pain, Postoperative; Postoperative Complications; Postoperative Nausea and Vomiting; Pregnancy; Pruritus; Serotonin Antagonists

The analgesic effect of kappa partial agonist opioids (i.e. nalbuphine, pentazocine and butorphanol) is significantly greater in women. Recent evidence suggests that this sexual dimorphism may result from a naloxone-sensitive anti-analgesic effect that is activated along with, and summates with, the analgesic effect of these agents, resulting in decreased analgesia or increased pain. For example, nalbuphine (5 mg) produces profound anti-analgesia (i.e. enhanced pain) in men, but addition of a low dose of the opioid receptor antagonist naloxone (0.4 mg, opioid antagonist) induces significant analgesia in men and enhances nalbuphine analgesia in women. To further delineate the dose-dependent relationship of nalbuphine and naloxone, we recently evaluated the effect of a lower dose of nalbuphine (2.5 mg) with and without naloxone (0.4 mg) on dental postoperative pain. In women, nalbuphine alone induced modest short duration analgesia, which was antagonized by the addition of naloxone. In men, this dose of nalbuphine alone did not produce analgesia or anti-analgesia, and naloxone did not alter the response to nalbuphine. Thus, it appeared that the 2.5 mg dose of nalbuphine was not sufficient to induce anti-analgesia while the 0.4 mg dose of naloxone was able to antagonize the analgesic effect of nalbuphine, at least in women. In the current study, we tested the hypothesis that an important determinant of naloxone enhancement of nalbuphine analgesia is the dose ratio of nalbuphine to naloxone. Since a dose ratio of 12.5:1 (i.e. 5 mg nalbuphine:0.4 mg naloxone) resulted in analgesic enhancement, but a dose ratio of 6.25:1 (2.5 mg:0.4 mg) did not, we tested the same, lower, dose of nalbuphine (2.5 mg) in combination with a lower dose of naloxone (0.2 mg) to maintain the 12.5:1 dose ratio. This lower dose of naloxone significantly prolonged the analgesic effect of nalbuphine in both men and women, suggesting that the anti-analgesic effect of nalbuphine is present in both sexes at the 2.5 mg dose and that the dose ratio of nalbuphine to naloxone is an important determinant of the analgesic efficacy of this combination.

Topics: Adult; Analgesics, Opioid; Dose-Response Relationship, Drug; Drug Synergism; Drug Therapy, Combination; Female; Humans; Male; Nalbuphine; Naloxone; Narcotic Antagonists; Pain, Postoperative; Sex Factors; Tooth Extraction

Intravesical morphine was recently recommended to reduce postoperative pain after reimplantation surgery for vesicoureteral reflux in children. The efficacy of such treatment, so far solely evaluated by open study, needed to be confirmed.. After parental informed consent was obtained, 80 children requiring Cohen cross-trigonal reimplantation were considered for inclusion in a double-blind study. On the day of surgery patients were randomly assigned to receive either 0.04 mg./kg. morphine per hour or placebo (normal saline) at a constant intravesical infusion rate of 0.08 ml./kg. per hour. Postoperative pain was assessed every 3 hours using a pain score adapted to patient age. If the score was above a predefined limit, patients received intravenous acetaminophen and nalbuphine alternately every 3 hours. Bladder infusion was discontinued after 48 hours.. Mean and maximum pain scores as well as the number of scores above the limit were not statistically different when comparing the morphine and placebo groups. There was no difference in the number of doses of analgesics administered. Urine output, voiding frequency and the number of painful voiding episodes were not significantly different between the 2 groups. Plasma morphine concentrations were 3.0 +/- 2.7 and 1.9 +/- 1.9 ng./ml. at 24 and 48 hours in the morphine group and undetectable in the placebo group.. Intravesical administration of morphine is not effective for relieving postoperative pain during the first 48 hours after intravesical ureteral reimplantation. This study emphasizes the importance of controlled studies in evaluating the effectiveness of a new drug or procedure before recommending its use for all patients.

Topics: Acetaminophen; Administration, Intravesical; Adolescent; Child; Child, Preschool; Double-Blind Method; Female; Humans; Infant; Infusions, Intravenous; Male; Morphine; Nalbuphine; Pain Measurement; Pain, Postoperative; Treatment Failure; Vesico-Ureteral Reflux

The aim of this study was to compare the analgesic efficacy of three different postoperative treatments after supratentorial craniotomy. Sixty-four patients were allocated prospectively and randomly into three groups: paracetamol (the P group, n = 8), paracetamol and tramadol (the PT group, n = 29), and paracetamol and nalbuphine (the PN group, n = 27). General anesthesia was standardized with propofol and remifentanil using atracurium as the muscle relaxant. One hour before the end of surgery, all patients received 30 mg/kg propacetamol intravenously then 30 mg/kg every 6 hours. Patients in the PT group received 1.5 mg/kg tramadol 1 hour before the end of surgery. For patients in the PN group, 0.15 mg/kg nalbuphine was injected after discontinuation of remifentanil, because of its mu-antagonist effect. Postoperative pain was assessed in the fully awake patient after extubation (hour 0) and at 1, 2, 4, 8, and 24 hours using a visual analog scale (VAS). Additional tramadol (1.5 mg/kg) or 0.15 mg/kg nalbuphine was administered when the VAS score was > or = 30 mm. Analgesia was compared using the Mantha and Kaplan-Meier methods. Adverse effects of the drugs were also measured. The three groups were similar with respect to the total dose of remifentanil received (0.27 +/- 0.1 mircog/kg/min). In all patients, extubation was obtained within 6 +/- 3 minutes after remifentanil administration. Postoperative analgesia was ineffective in the P group; therefore, inclusions in this group were stopped after the eighth patient. Postoperative analgesia was effective in the two remaining groups because VAS scores were similar, except at hour 1, when nalbuphine was more effective (P = .001). Nevertheless, acquiring such a result demanded significantly more tramadol than nalbuphine (P < .05). More cases of nausea and vomiting were observed in the PT group but the difference was not significant (P < .06). In conclusion, pain after supratentorial neurosurgery must be taken into account, and paracetamol alone is insufficient in bringing relief to the patient. Addition of either tramadol or nalbuphine to paracetamol seems necessary to achieve adequate analgesia, with, nevertheless, a larger dose of tramadol to fulfill this objective.

Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Anesthesia, Intravenous; Anesthetics, Intravenous; Craniotomy; Double-Blind Method; Drug Therapy, Combination; Female; Glasgow Coma Scale; Humans; Male; Middle Aged; Nalbuphine; Pain Measurement; Pain, Postoperative; Piperidines; Propofol; Remifentanil; Supratentorial Neoplasms; Tramadol

Pain control is an important consideration after any surgical procedures. Especially in children, more attention and care are needed during the period of postoperative pain control, which must be both sufficiently safe and effective. In this respect, intravenous patient-controlled analgesia provides improved titration of analgesic drugs, thereby maintaining optimal analgesic status with few side effects. Thirty pediatric patients were randomly divided into two groups: the intravenous patient-controlled analgesia group (with nalbuphine HCl and ketorolac tromethamine) and the conventional pethidine HCl intramuscular group. The degree of analgesia was assessed every 4 hours until the second postoperative day. The intravenous patient-controlled analgesia group had significantly lower pain scores and took less time until they were able to walk to the bathroom, but as many side effects as the control group. We concluded that intravenous patient-controlled analgesia is safe and effective for pediatric patients who have moderate to severe pain after operations such as rib cartilage graft, iliac bone graft, and large flap surgeries.

Topics: Analgesia, Patient-Controlled; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Bone Transplantation; Cartilage; Child; Child, Preschool; Female; Follow-Up Studies; Headache; Humans; Injections, Intramuscular; Injections, Intravenous; Ketorolac Tromethamine; Male; Meperidine; Nalbuphine; Pain Measurement; Pain, Postoperative; Postoperative Nausea and Vomiting; Safety; Statistics, Nonparametric; Surgical Flaps; Time Factors; Walking

The analgesic properties of the partial agonist-antagonist nalbuphine in the postoperative period are well known. When used for patient-controlled analgesia (PCA) the effectiveness of this substance is comparable to that of morphine or tramadol. However, the optimal programme for administration of nalbuphine in PCA-pumps has not been investigated. In particular, the combination of bolus administration vs bolus administration plus continuous basal administration is disputable. We hypothesized that the administration of an extra basal rate of nalbuphine in addition to the patient- triggered bolus administration and supplemental doses of diclofenac when required, would lead to a significant improvement in analgesia, without affecting the differences in vital signs and side effects. After approvement by the institutional ethics committee, 50 female patients (ASA I or II) scheduled for elective hysterectomy were included in a prospective, single-blinded study and randomized either into bolus-continuous (BC-)group (3 mg base rate/h, 1 mg bolus, 20 min lock out) or bolus (B-)group (no base rate, 1 mg bolus, 10 min lock out). During the observation period (up to 24 h postoperative) vital parameters, extent of analgesia (10-step VAS), and vigilance (5-step scale) were registered. Groups were compared by using unpaired Student t-test. A p<0.05 was considered to be significant. No differences were found in demographic data or vital parameters (MAP, PaO2, PaCO2, respiratory rate, heart rate, peripheral SaO2) during the observation period. Vital parameters showed no pathological changes in any group. With an identical rate of requirement for diclofenac (32 and 36%), analgesia in BC-group showed a decrease in VAS from 4.28+/-2.11 to 2.04+/-1.21 and from 3.64+/-2.20 to 2.08+/-0.96 in B-group. Vigilance was only marginally diminished in both groups. No serious side effects were found in either group. The consumption of nalbuphine (mg) was significantly higher in BC-group (70.28+/-13.85 vs. 47.44+/-22.99;p =0.0002) when compared to B-group. Subjective rating of effectiveness by the patients was similar in both groups. The two administration settings of nalbuphine by PCA pump have shown to be equally effective in the treatment of postoperative pain following hysterectomy. However, as the total amount of nalbuphine was significantly lower in B-group, the use of this administration schedule should be encouraged.

Topics: Adult; Aged; Analgesia, Patient-Controlled; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Female; Humans; Hysterectomy; Infusion Pumps; Middle Aged; Nalbuphine; Pain, Postoperative; Prospective Studies; Pulse Therapy, Drug; Single-Blind Method

We performed a prospective, randomized, double-blinded, multicenter study to compare the analgesic efficacy and adverse effects of intrathecal nalbuphine, at three different doses, and intrathecal morphine for postoperative pain relief after cesarean deliveries. Ninety healthy patients at full term who were scheduled for elective cesarean delivery with spinal anesthesia were enrolled in the study. They received 10 mg of hyperbaric bupivacaine 0.5% with either morphine 0.2 mg (Group 1), nalbuphine 0.2 mg (Group 2), nalbuphine 0. 8 mg (Group 3), or nalbuphine 1.6 mg (Group 4). Only patients in Groups 1 and 2 reported pain during surgery. Postoperative analgesia lasted significantly longer in the morphine group, compared with the nalbuphine groups (P: < 0.0001). In the nalbuphine groups, postoperative analgesia lasted longest with the 0.8-mg dose. The additional increase to 1.6 mg did not increase efficacy. The incidence of pruritus was significantly higher in Group 1 (11 of 22), compared with Group 2 (0 of 22, P: < 0.0002), Group 3 (0 of 23, P: < 0.0001), and Group 4 (3 of 20, P: < 0.02). Postoperative nausea and vomiting were more frequent in Group 1 (5 of 22), compared with Group 2 (0 of 22, P: < 0.05), Group 3 (0 of 23, P: < 0.05), and Group 4 (3 of 23, not significant). There was no maternal or newborn respiratory depression. Neonatal conditions (Apgar scores and umbilical vein and artery blood gas values) were similar for all groups. This study suggests that intrathecal nalbuphine 0.8 mg provides good intraoperative and early postoperative analgesia without side effects. However, only morphine provides long-lasting analgesia.. Small doses of intrathecal nalbuphine produce fewer adverse effects, such as pruritus and postoperative nausea and vomiting, compared with intrathecal morphine. This may allow earlier discharge of patients from the recovery room.

Topics: Adult; Analgesics, Opioid; Cesarean Section; Double-Blind Method; Female; Humans; Injections, Spinal; Morphine; Nalbuphine; Pain Measurement; Pain, Postoperative; Postoperative Nausea and Vomiting; Pregnancy; Prospective Studies

Previous work has demonstrated that intraperitoneal (i.p.) lidocaine may provide analgesia after laparoscopic cholecystectomy. The aim of this prospective, randomized, double-blind study was to compare pain relief, recovery variables, and side effects after i.p. instillation of lidocaine plus tenoxicam given either i.v. or i.p. after laparoscopic cholecystectomy.. Ninety patients were randomly allocated to one of three groups to receive either 200 ml normal saline i.p. and 2 ml of normal saline i.v. (saline group), 200 ml lidocaine 0.1% i.p. and 2 ml tenoxicam 20 mg i.v. (tenoxicam i.v. group), or 200 ml lidocaine 0.1% with 20 mg tenoxicam i.p. and 2 ml of normal saline i.v. (tenoxicam i.p. group). The i.p. instillation was made under the right diaphragm and on the gall bladder bed. VAS pain scores at rest, on movement and during coughing, were measured 2, 4, 6, 12, and 24 h after operation. The time to first demand of analgesia, total analgesic requirement, recovery variables, and side effects were investigated.. In the tenoxicam i.p. group, pain scores were significantly lower both at rest and on movement and analgesic consumption was reduced compared with the saline group (P<0.05). In the tenoxicam i.v. group, pain scores at rest were significantly lower compared with the saline group. Although recovery of bowel function was significantly faster in the tenoxicam i.p. group (P<0.05), there were no differences in any other recovery characteristics or incidence of nausea between the groups.. Combination of intraperitoneal lidocaine and tenoxicam provided better analgesia on movement, and faster return of bowel function compared with i.p. lidocaine and i.v. tenoxicam during the 24 h period after surgery.

Topics: Adult; Analgesics, Opioid; Anesthetics, Local; Anti-Inflammatory Agents, Non-Steroidal; Cholecystectomy, Laparoscopic; Digestive System; Digestive System Physiological Phenomena; Female; Humans; Injections, Intraperitoneal; Injections, Intravenous; Lidocaine; Male; Middle Aged; Nalbuphine; Pain Measurement; Pain, Postoperative; Piroxicam; Postoperative Nausea and Vomiting

We designed this study to compare the postoperative analgesic effects of intrathecal morphine and nalbuphine, the endpoints being onset and offset of action.. Geriatric patients scheduled for elective total hip replacement under continuous spinal anaesthesia were randomized to two double-blinded groups in the recovery room as soon as they experienced a pain score higher than 3 cm on the visual analogue scale (VAS, 0-10 cm). Either 160 microg morphine or 400 microg nalbuphine in 4 ml normal saline were administered intrathecally. Pain scores on VAS, rescue analgesia (diclofenac and morphine, not allowed during the first 60 min), and the adverse effects (respiratory depression, postoperative nausea and vomiting, itching) were recorded for 24 h after surgery.. The study was stopped after inclusion of 2 x 12 patients due to slow onset of analgesia in the morphine patients. In the nalbuphine group, when compared to the morphine group, the time to a pain score <3 cm (8+/-6 vs. 31+/-32 min, P<0.001), the time to the lowest pain score (18+/-11 vs. 66+/-75 min, P<0.001) and the time to the first systemic analgesic intervention for a pain score >3 cm (218+/-256 vs. 1076+/-440 min, P<0.05) were significantly shorter. The analgesic requirements during the first 24 h were significantly lower in the morphine group (P<0.001).. We conclude that after total hip replacement, administration of intrathecal nalbuphine resulted in a significantly faster onset of pain relief and shorter duration of analgesia than intrathecal morphine.

Topics: Aged; Analgesics, Opioid; Arthroplasty, Replacement, Hip; Double-Blind Method; Female; Hemodynamics; Humans; Injections, Spinal; Male; Morphine; Nalbuphine; Pain Measurement; Pain, Postoperative; Postoperative Nausea and Vomiting

Nalbuphine, pentazocine, and butorphanol, mixed agonist/antagonist opioids that induce analgesia by acting predominantly at kappa opioid receptors, have recently been shown in single-dose studies to have greater analgesic efficacy in women than in men. In the current experiments, the first placebo controlled dose response study of opioid analgesic efficacy that examines for gender differences, nalbuphine (5, 10, or 20 mg) and placebo were evaluated in 62 men and 69 women for the treatment of moderate to severe postoperative pain following extraction of impacted wisdom teeth. In a randomized, open injection, double blind experimental design, pain intensity was recorded on a 10 cm visual analog scale (VAS) immediately prior to drug administration (baseline) and at 20 min intervals thereafter. Although responses to placebo were similar in men and women, for all doses of nalbuphine women exhibited significantly greater analgesic response than men, compatible with our previous results. Unexpectedly, men receiving the 5 mg dose of nalbuphine experienced significantly greater pain than those receiving placebo; only the 20 mg dose of nalbuphine in men produced significant analgesia compared to placebo. While a similar antianalgesic effect was not observed in women, only the 10 mg dose of nalbuphine produced significant analgesia compared to placebo. These results suggest that the optimal analgesic dose of nalbuphine for women is lower than the highest dose that can be safely administered. In contrast, the antianalgesic effect of nalbuphine suggests avoidance of its routine use for postoperative analgesia in men until further studies clarify this issue. Because gender differences in other mixed kappa agonists/antagonists (i.e. pentazocine and butorphanol) have previously been shown, these results may generally apply to this class of opioid analgesics.

Topics: Adult; Analgesics, Opioid; Analysis of Variance; Dose-Response Relationship, Drug; Female; Humans; Male; Nalbuphine; Oral Surgical Procedures; Pain Measurement; Pain, Postoperative; Placebos; Receptors, Opioid, kappa; Sex Characteristics; Time Factors

The aim of this study was to evaluate the efficacy and side effects of PCA nalbuphine (intravenous) versus morphine on postoperative pain in Chinese gynecologic patients.. Sixty women undergoing abdominal hysterectomy or myomectomy under spinal anesthesia were enrolled into the investigation. Patients were randomly divided into 2 groups (n = 30 each). Group 1 received intravenous nalbuphine using PCA device for the management of postoperative pain, whereas group 2 received PCA morphine for the same purpose. During the first 48 hours postoperatively, we collected the following data: analgesic doses, pain scores, vital signs, nausea, vomiting, pruritus and dizziness.. The results showed that despite different treatments, pain scores on day 1 and day 2 postoperatively were low and were not significantly different between groups. Meanwhile, the cumulative consumption of PCA nalbuphine (32 +/- 10 mg) and PCA morphine (30 +/- 9 mg) was similar. Both treatments showed only minor side effects and the incidence of each side effect was not significant between groups.. Both PCA nalbuphine and morphine are effective in the treatment of postoperative pain in Chinese gynecologic patients undergoing hysterectomy or myomectomy after spinal anesthesia and the potency of nalbuphine is similar to that of morphine.

Topics: Analgesia, Patient-Controlled; Analgesics, Opioid; Female; Gynecologic Surgical Procedures; Humans; Middle Aged; Morphine; Nalbuphine; Pain, Postoperative

The impact of hypnotic drugs on postoperative analgesia has not been evaluated. We compared the influence of the maintenance of anaesthesia with either propofol or isoflurane on postoperative pain.. Forty ASA 1-2 women, undergoing cosmetic abdominoplasty were randomized to receive either 6-12 mg.kg-1.hr-1 propofol i.v. (P, n = 20) or MAC 1-1.5 isoflurane inhalation (Iso, n = 20). The lungs were ventilated with N2O 60% and O2 40%, and 1 microgram.kg-1 fentanyl i.v. provided intraoperative analgesia. Before surgical closure, 2 g propacetamol i.v. were administered. Postoperative analgesia was provided after hourly assessment of pain (VAS 0-100 mm), with 10 mg nalbuphine i.v. if VAS > or = 50 mm, during the eight hours after surgery. Sedation score (awake 0 to unrousable 4) was also recorded. Analgesia satisfaction score (nil 0 to excellent 4) obtained from the patient on discharge.. Sedation scores were similar in both groups except in the first postoperative hour, when it was higher in the Iso group. The VAS at rest (15.4 +/- 18.6 vs 29.7 +/- 19.8 mm, P = 0.0001) and nalbuphine requirements (0.13 +/- 0.35 vs 0.70 +/- 0.80 doses, P = 0.004) were lower in the Iso group during the first six hours, although emesis was more frequent than in P (60 vs 25%; P = 0.03). The incidence of analgesia satisfaction score (> or = 3) was similar between the two groups (P: 95; Iso: 75%).. These results suggested that isoflurane anaesthesia provides better analgesia than propofol anaesthesia in the first six hours after abdominoplasty.

Topics: Abdomen; Acetaminophen; Adult; Analgesia; Analgesics; Analgesics, Opioid; Anesthetics, Inhalation; Anesthetics, Intravenous; Female; Fentanyl; Humans; Injections, Intravenous; Intraoperative Care; Isoflurane; Nalbuphine; Pain Measurement; Pain, Postoperative; Patient Satisfaction; Propofol; Vomiting

To compare analgesia produced after surgery for severe hand trauma, by a continuous axillary block obtained either with a continuous injection (CA) or controlled by the patient (PCA).. Prospective, randomized study.. Forty-two ASA physical class 1 and 2 patients were enrolled over a twelve-month period and randomly allocated either into the CA or the PCA group.. After recovery from the surgical block, the axillary plexus was located using a nerve stimulator and a 20 G catheter (Contiplex B Braun) inserted over 5 centimeters into the axillary sheath. In the CA group (n = 21) patients received 0.1 mL.kg-1.h-1 of 0.25% bupivacaine and in the PCA group (n = 21) patients received 0.1 mL.kg-1 boluses of 0.25% bupivacaine with a one hour lock-out period. Data collected were pain intensity rated according to he visual analog scale (VAS), the total volume of bupivacaine injected, the quantity of nalbuphine administered as 10 mg boluses when VAS was = 5, and the patient's satisfaction after removal of the catheter. Statistical analysis used Student t test, ANOVA and chi 2 test.. The mean duration of catheter use was 5 +/- 3 days. During this period the amount of bupivacaine was significantly reduced in the PCA group when compared to the CA group (P < 0.001). Similarly, the PCA group required significantly less nalbuphine. Finally, in this group, the satisfaction index was higher than in the CA group (95 versus 52% respectively, P < 0.01).. Continuous axillary plexus blockade provides safe and effective postoperative analgesia. With the PCA technique results a lower quantity of bupivacaine is required and patient's satisfaction better.

Topics: Adolescent; Adult; Aged; Analgesia; Analgesia, Patient-Controlled; Analgesics; Analgesics, Opioid; Analysis of Variance; Anesthetics, Local; Axilla; Bupivacaine; Chi-Square Distribution; Female; Hand Injuries; Humans; Male; Middle Aged; Nalbuphine; Nerve Block; Pain Measurement; Pain, Postoperative; Patient Satisfaction; Prospective Studies

To determine the efficacy of lumbar intrathecal (i.t.) morphine in a dose of 0.02 mg/kg in providing analgesia following repair of frontal encephaloceles.. Prospective, open-label investigation of i.t. morphine with secondary comparison to a retrospective cohort.. Metropolitan hospital in the Philippines.. 24 ASA physical status I and II children undergoing frontal encephalocele repair.. Following induction of general anesthesia. I.t. morphine (Group 1) was administered via single-shot technique or through a lumbar i.t. drain placed for cerebrospinal fluid drainage during the surgical procedure. Postoperative analgesia was assessed by visual analog score in patients greater than 5 years of age or a behavioral score in patients less than 5 years of age. The retrospective cohort received postoperative analgesia with intermittent doses of intravenous nalbuphine (Group 2).. Group 1 had decreased postoperative analgesic requirements, decreased intraoperative inhalational anesthetic requirements, and a longer time to the first request for postoperative analgesia than Group 2. The time to the first request for postoperative analgesia was 16.0 +/- 9.1 hours in Group 1 and 1.6 +/- 1.2 hours in Group 2 (p < 0.0001). Six of 12 patients in Group 1 required no analgesic drugs during the first 24 postoperative hours while all 12 patients in Group 2 (p = 0.02) did require analgesic drugs during this period. The patients in Group 1 who did not require supplemental analgesic drugs maintained pain scores of 2 or less throughout the first 24 postoperative hours.. Lumbar IT morphine provides effective analgesia following repair of frontal encephaloceles in children and adolescents.

Topics: Analgesics, Opioid; Child; Child, Preschool; Encephalocele; Female; Frontal Lobe; Humans; Injections, Intravenous; Injections, Spinal; Male; Morphine; Nalbuphine; Pain Measurement; Pain, Postoperative; Prospective Studies; Retrospective Studies

Opioids may depress respiration and contribute to airway obstruction after adenotonsillectomy for obstructive sleep disorder. We compared the respiratory and analgesic effects of nalbuphine, which has a ceiling effect for respiratory depression, and pethidine in 90 children (aged 2-12 years) with a history of obstructive sleep disorder undergoing adenotonsillectomy. Children were scored for their obstructive sleep disorder history and were randomly allocated to receive intravenously at induction of anaesthesia either nalbuphine 0.1 mg.kg-1 (group N) or pethidine 1 mg.kg-1 (group P). End-tidal carbon dioxide was measured in the recovery period using a nasopharyngeal catheter and oxygen saturation whilst breathing air; pain and sedation scores were recorded for 6 h postoperatively. Both groups were similar with respect to the demographic data and respiratory measurements: mean (SD) oxygen saturation on air in the recovery area (96.2% (1.2) vs. 96.5% (1.1) in group N and P, respectively) and mean (SD) end-tidal carbon dioxide (46.4 (5.5) mmHg vs. 47.7 (4) mmHg in group N and P, respectively). High obstructive sleep disorder score, history of apnoea, hyperactivity and loud snoring were found to be the best predictors of early postoperative oxygen desaturation in both groups.

Topics: Adenoidectomy; Analgesics, Opioid; Carbon Dioxide; Child; Child, Preschool; Drug Administration Schedule; Female; Humans; Hypoxia; Male; Meperidine; Nalbuphine; Oxygen; Pain, Postoperative; Postoperative Complications; Respiration; Risk Factors; Sleep Apnea Syndromes; Tonsillectomy

Nalbuphine (0.3 mg.kg-1) and buprenorphine (2.5 micrograms.kg-1) were compared as part of a total intravenous anaesthesia regimen using a propofol infusion in 60 patients undergoing laparoscopic cholecystectomy in a randomised double-blind study. Changes in haemodynamic variables greater than 20% from the baseline were noted. No difference was observed in blood pressure but the heart rate was significantly lower in the buprenorphine group. Intra-operative bradycardia (heart rate < 60 beat.min-1) occurred more often in the buprenorphine group. Recovery was fast and comparable with both drugs and no patient reported awareness. Quality of analgesia was similar in both groups. Both drugs provide suitable analgesic supplementation to total intravenous anaesthesia.

Topics: Adult; Analgesics, Opioid; Anesthesia, Intravenous; Bradycardia; Buprenorphine; Cholecystectomy, Laparoscopic; Double-Blind Method; Drug Administration Schedule; Hemodynamics; Humans; Middle Aged; Nalbuphine; Pain, Postoperative; Patient Satisfaction; Postoperative Complications

This randomized, double-blind study compared the efficacy of two mu-receptor antagonists, naloxone and nalbuphine, in the prophylactic management of pruritus in postcesarean section patients receiving epidural morphine. Dosages of study drugs were individualized by the use of a patient self-administration (PSA) device. All 51 patients were healthy women who received a uniform epidural anesthetic and epidural morphine (5 mg). Coded solutions were infused for 24 h, with 5-min PSA lockout times: Group A (n = 17), nalbuphine 2.5 mg/h, PSA nalbuphine 1 mg; Group B (n = 16), naloxone 50 micrograms/hr, PSA saline; Group C (n = 18), naloxone 50 micrograms/h, PSA naloxone 40 micrograms. Patients were assessed for pruritus and pain every 8 h for 24 h. Both naloxone and nalbuphine provided good relief for pruritus; median pain and pruritus scores were in the none-to-mild range (0-3) for all groups at all assessment intervals. The pruritus scores of the PSA saline group were higher during the 16- to 24-h period (P < 0.05) than the scores of either group receiving A-receptor antagonist by PSA. There was evidence of shortening of the duration of analgesia in patients receiving naloxone who required treatment for pruritus after 16 h. Patients who self-administered large doses of nalbuphine over the first 8 h also reported pain scores consistent with reversal of analgesia. The potency ratio for naloxone:nalbuphine for antagonism of the pruritic effects of epidural morphine was approximately 40:1. Intervention to treat either unrelieved pruritus or pain, respectively, was necessary in the following numbers of patients: Group A, 0/1; Group B, 1/1; Group C, 2/2. Prophylactic infusions offer the potential for labor cost savings by minimizing the need for episodic therapeutic interventions to treat pruritus.

Topics: Analgesia, Epidural; Analgesia, Obstetrical; Analgesia, Patient-Controlled; Analgesics, Opioid; Cesarean Section; Cost Savings; Double-Blind Method; Female; Humans; Linear Models; Morphine; Nalbuphine; Naloxone; Narcotic Antagonists; Pain Measurement; Pain, Postoperative; Pregnancy; Pruritus; Receptors, Opioid, mu

To measure the incidence of nausea and vomiting in outpatients in relation to selection of, or withholding of, intraoperative opioid.. Prospective, randomized, double-blind control trial.. University general hospital.. 200 unpremedicated ASA status 1 and 11 patients, 8 to 80 years old, undergoing general anesthesia for ambulatory surgery.. Patients were randomized to four groups, three of which received equipotent doses of different opioids intravenously (i.v.) during induction of anesthesia. Group 1 received nalbuphine 0.25 mg/kg, Group 2, alfentanil 20 ug/kg; Group 3, fentanyl 2 ug/kg; and Group 4, normal saline.. We evaluated (1) incidence and severity of nausea and vomiting in the postanesthesia care unit (PACU) and over the next 24 hours; (2) time to PACU discharge; (3) need for antiemetic therapy; and (4) need for analgesic rescue in the PACU. The incidences of nausea and vomiting were similar in all groups, as were time to discharge, antiemetic, and nonsteroidal antiinflammatory drug requirements. The highest incidences of nausea and vomiting occurred at 6 hours in all groups (23% and 9.5%, respectively). Group 1 required lower rescue doses of morphine in the PACU but this result may have been an artifact due to employing the mixed agonist-antagonist opioid, nalbuphine, in this group.. Opioid administration at the doses employed during induction of anesthesia does not promote postoperative nausea or vomiting, nor increase length of stay in the PACU.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alfentanil; Ambulatory Surgical Procedures; Analgesics, Opioid; Anesthesia, General; Child; Double-Blind Method; Female; Fentanyl; Humans; Intraoperative Complications; Male; Middle Aged; Nalbuphine; Nausea; Pain, Postoperative; Prospective Studies; Vomiting

Continuous intravenous infusions of fentanyl, buprenorphine or nalbuphine were investigated to provide pain relief for patients after major abdominal surgery. Buprenorphine (n = 23) was given as a loading dose of 5 micrograms kg-1 and infused at 0.8 micrograms kg-1 h-1. Fentanyl (n = 20) was given as a loading dose of 2 micrograms kg-1 and infused at 0.7 micrograms kg-1 h-1. Nalbuphine (n = 21) was given as a loading dose of 200 micrograms kg-1 and infused at 80 micrograms kg-1 h-1. The infusion rate was increased when analgesia was inadequate, and decreased if respiratory depression occurred. Mean doses were respectively 0.74 +/- 0.15 microgram kg-1 h-1 buprenorphine, 0.68 +/- 0.18 microgram kg-1 h-1 fentanyl, 83 +/- 21 micrograms kg-1 h-1 nalbuphine. Titration of continuous intravenous infusion of buprenorphine and fentanyl provided better analgesia than nalbuphine with smaller doses than those reported in similar studies allowing spontaneous breathing.

Topics: Adult; Aged; Analgesia; Analgesics, Opioid; Buprenorphine; Female; Fentanyl; Humans; Infusions, Intravenous; Male; Middle Aged; Nalbuphine; Pain, Postoperative; Prospective Studies

In a randomized double-blind study 60 children, undergoing the extraction of carious deciduous teeth under day-case general anaesthesia, were assigned to receive either intravenous nalbuphine hydrochloride 0.3 mg kg-1 (n = 21), one or more diclofenac suppositories 12.5 mg to a dose of 1-2 mg kg-1 (n = 19), or no analgesia (n = 20). The duration of anaesthesia was longer in the diclofenac group (9.6 min, SD 3.5) compared with control (7.2 min, SD 2.6) and nalbuphine (6.9 min, SD 3.0) groups respectively (P < 0.05). There were no statistically significant differences in post-operative pain scores during the 45 min post-operative period studied between the three groups using an objective pain score. We conclude that using this methodology we were unable to demonstrate any statistically significant differences between the analgesic effects of either intravenous (i.v.) nalbuphine or diclofenac suppositories compared with control.

Topics: Acetaminophen; Administration, Rectal; Ambulatory Surgical Procedures; Analgesics, Non-Narcotic; Analgesics, Opioid; Anesthesia, Dental; Anesthesia, General; Anti-Inflammatory Agents, Non-Steroidal; Child; Child Behavior; Child, Preschool; Dental Caries; Diclofenac; Double-Blind Method; Female; Humans; Injections, Intravenous; Male; Nalbuphine; Pain, Postoperative; Suppositories; Time Factors; Tooth Extraction; Tooth, Deciduous

We have studied the analgesic efficacy of a single i.v. dose of tenoxicam 20 mg, given 10 min before induction of anaesthesia in 25 patients undergoing elective Caesarean section. Another group of 25 similar patients served as controls. Nalbuphine consumption in the first 24 h after operation was reduced by 50% when tenoxicam was given. The median time to first request for analgesia was increased from 25 to 110 min in the tenoxicam group. Subjective experiences of pain and sedation were significantly greater in the control group up to 24 h after operation. The haemodynamic variability after intubation was of shorter duration in the tenoxicam group. There was no significant difference in incidence and severity of postoperative nausea and vomiting between the two groups. The surgeon's assessment of uterine relaxation and bleeding, using a visual analogue score, and infant well-being, as judged by Apgar score and cord blood-gas analysis, showed no significant difference between the two groups. There was no evidence of premature closure of the ductus arteriosus or pulmonary hypertension. We conclude that a single i.v. dose of tenoxicam is a useful pretreatment to minimize the haemodynamic variability of light general anaesthesia at induction-delivery and in reducing 24 h postoperative opioid consumption.

Topics: Adult; Analgesia, Obstetrical; Anti-Inflammatory Agents, Non-Steroidal; Cesarean Section; Double-Blind Method; Female; Humans; Injections, Intravenous; Nalbuphine; Pain, Postoperative; Piroxicam; Pregnancy; Premedication; Time Factors

This prospective randomized single-blind study compared the efficacy of a combination of propacetamol (2 g) and a low dose of nalbuphine hydrochloride (10 mg) with nalbuphine hydrochloride (20 mg) alone, in a population of 152 white female patients after gynaecologic or obstetrical surgery, for alleviation of postoperative pain in recovery room. The drugs were administered intravenously in case of pain. The population was divided into two groups: group 1 received 20 mg of nalbuphine hydrochloride and group 2 received 2 g of propacetamol combined with 10 mg of nalbuphine hydrochloride. The pain intensity was studied with the visual analogue scale and comparisons use no parametric tests (Mann and Whitney test, Kruskall and Wallis test) and Chi2 test. Groups were similar for age, surgical and anaesthesia procedures and initial pain level. The propacetamol-nalbuphine hydrochloride 10 mg association provided a significantly better analgesia than nalbuphine 20 mg during the first two postoperative hours (p < 0.05). In group 1, the analgesia score decrease was respectively 28 +/- 25 mm (range: 33-75 mm) after 1 h and 31 +/- 25 mm (range: 26-84 mm) after 2 h. In group 2, the decrease was more important: 37 +/- 21 mm (range: 5-84 mm) after 1 h and 42 +/- 23 mm (range: 20-84 mm) after 2 h. Side effects were minimal and similar in both groups (nausea, drowsiness). It is concluded that a propacetamol-nalbuphine hydrochloride 10 mg association provides better analgesia than single dose of 20 mg of nalbuphine. This association convenient analgesia with a decreased dose of nalbuphine.

Topics: Acetaminophen; Adult; Analgesics; Cesarean Section; Drug Combinations; Female; Genital Diseases, Female; Humans; Hysterectomy; Laparotomy; Middle Aged; Nalbuphine; Pain Measurement; Pain, Postoperative; Pregnancy

This prospective, randomized, controlled investigation compared the effects of three prophylactic mu-opioid antagonists, epidural butorphanol (BU) 3 mg, epidural nalbuphine (NB) 10 mg, and oral naltrexone (NX) 6 mg, on postcesarean epidural morphine analgesia. After randomization, 102 term parturients underwent cesarean delivery with epidural anesthesia, 2% lidocaine and epinephrine 1:200,000. When the umbilical cord was clamped, each patient received one epidural solution (containing morphine 4 mg plus either saline or treatment drug), and one oral capsule (containing either placebo or treatment drug) in a double-blind manner. Maternal outcomes included pain and satisfaction [assessed with 100-mm visual analog scales (VAS)], and the incidence and severity of respiratory depression, somnolence, pruritus, nausea, and emesis. Through the first 12 h postpartum, the BU group achieved significantly greater analgesia than the morphine sulfate (control) (MS), NB, and NX groups, a significantly lower incidence of severe pruritus than the MS group, and significantly greater satisfaction than MS and NX groups. Epidural morphine and BU promoted better analgesia and satisfaction than any previously documented postcesarean regimen.

Topics: Adult; Analgesia, Epidural; Analgesia, Obstetrical; Butorphanol; Cesarean Section; Female; Humans; Morphine; Nalbuphine; Naltrexone; Narcotic Antagonists; Pain, Postoperative; Pregnancy; Prospective Studies

This study compared naloxone and nalbuphine when administered for treatment of side effects after epidural morphine, 5 mg, given for postcesarean analgesia. Patients requesting treatment for pruritus or nausea randomly received, in a double-blind fashion, up to three intravenous doses of either naloxone 0.2 mg (group 1; n = 20) or nalbuphine 5 mg (group 2; n = 20). The incidence of vomiting, the severity of nausea and pruritus, and the degree of sedation and pain were assessed before and 30 min after each dose. The first dose of nalbuphine decreased the incidence of vomiting (P < 0.005) and the severity of nausea and pruritus (P < 0.01), whereas naloxone caused no significant changes. Sedation scores increased after nalbuphine (P < 0.05) and remained unchanged after naloxone, whereas pain scores increased after naloxone (P < 0.01) and were unchanged after nalbuphine. Eighteen patients in group 1 and 12 in group 2 received a second dose, and 8 and 4 patients, respectively, a third dose. Other than decreased pruritus after the second dose with both drugs, no further changes occurred. We conclude that nalbuphine is superior to naloxone for the treatment of side effects after epidural morphine. However, persistent symptoms may require supplemental therapy, as repeated doses proved less effective than the initial dose.

Topics: Adult; Analgesia, Epidural; Cesarean Section; Female; Humans; Morphine; Nalbuphine; Naloxone; Pain, Postoperative; Pregnancy

The respiratory effects of analgesia with nalbuphine were studied in 9 patients after thoracotomy. The pain score was measured by a visual analogue scale. Ventilatory pattern and occlusion pressure (P0.1) were studied during spontaneous breathing and during CO2 rebreathing, before and 0.5, 1, 2.5, 3.5 and 6 h after a 0.3-mg.kg-1 dose of intravenous nalbuphine. Compared to baseline values obtained before the injection, nalbuphine produced a decrease in the pain score (p < 0.001) during the 6-hour experiment period. In spontaneous breathing, P.01 was reduced by 15% in 1 h and remained decreased during 3.5 h (p < 0.05), whilst PaCO2 and ventilation (VE) remained unchanged. The P0.1 responsiveness to CO2 was decreased from 0.5 to 2.5 h after the nalbuphine injection (p < 0.05), but the VE responsiveness to CO2 was reduced only after 1 h (p < 0.01). This study shows that, while post-thoracotomy pain was reduced by analgesia, neuromuscular inspiratory drive and chemosensitivity to CO2 were weakened, without any change in spontaneous ventilation. A partial improvement in the thoracopulmonary mechanics induced by the reduction in chest pain could explain the maintenance of ventilatory level in spite of a decreased neuromuscular inspiratory drive.

Topics: Analysis of Variance; Carbon Dioxide; Humans; Middle Aged; Nalbuphine; Oxygen; Pain, Postoperative; Pressure; Respiration; Thoracotomy

Topics: Analgesics; Bone and Bones; Double-Blind Method; Female; Humans; Injections, Intramuscular; Ketorolac; Male; Middle Aged; Nalbuphine; Pain, Postoperative; Tolmetin

The aim of the study was to examine the analgesic efficacy and applicability of the two analgesic drugs nalbuphine and tramadol, administered by continuous i.v. infusion combined with a patient-controlled analgesia device (PCA).. With informed consent and approval of the ethical committee, 40 patients were studied after abdominal hysterectomy in a randomized, double-blind order. Twenty received an initial postoperative dose of 10 mg nalbuphine followed by a continuous infusion of 5 mg/h and the possibility of an additional 5 mg every 30 min. The other 20 received equipotent analgesia consisting of an initial bolus of 50 mg tramadol i.v. followed by a continuous infusion of 25 mg/h and the possibility of an additional 25 mg every 30 min. Analgesia, sedation, general well-being, and acceptance of the patients as well as blood pressure, heart rate, respiratory rate, and pulse-oximetric O2 saturation were measured regularly during a 5-h postoperative period. Data were analyzed using the Mann-Whitney test, with P less than 0.05 considered significant; results were expressed as mean +/- standard deviation.. The postoperative pain score on the visual analogue scale (0 to 10) fell with nalbuphine from 7.14 +/- 3.45 to 2.03 +/- 1.25 and with tramadol from 7.81 +/- 2.85 to 1.57 +/- 1.40. There were no significant differences between the two groups. PCA supplements were requested 21.7 times in the nalbuphine group and 27.3 times in the tramadol group. General well-being of the patients on a 4-point scale (0 to 3) improved for the nalbuphine group from 0.70 +/- 0.92 to 2.11 +/- 0.49 and for the tramadol group from 0.62 +/- 0.67 to 2.33 +/- 0.50, which was significantly better in the nalbuphine group after 45, 60, and 90 min.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Analgesia, Patient-Controlled; Double-Blind Method; Female; Humans; Hysterectomy; Infusions, Intravenous; Middle Aged; Nalbuphine; Pain, Postoperative; Tramadol

A randomized investigation compared the efficacy and safety of nalbuphine administered by two methods, a patient-controlled infuser system and intramuscular (IM) injections, after major gynecologic surgery. Forty-seven patients were randomly assigned to receive nalbuphine by either method. The 22 patients using the infuser were given a 2.0-mg, incremental dose with a 10-minute lock-out interval between doses. A similar group receiving 10-15 mg IM every three hours served as the control. Misprogramming, overdosage, depressed respiration and drug dependence were not encountered. Self-administration provided equally satisfactory sedation and more immediate pain relief without painful injections. Although patients with the infuser had the ability to self-administer more medication, they did not use higher doses of nalbuphine than did the IM group. The additional cost of the infuser system was offset by the satisfaction expressed by the patients and by the improved nursing efficiency. Nalbuphine administered with a patient-controlled infuser provided an effective balance between analgesia and sedation and offered advantages over IM injections.

Topics: Adult; Analgesia, Patient-Controlled; Female; Genital Diseases, Female; Humans; Infusion Pumps; Injections, Intramuscular; Middle Aged; Nalbuphine; Pain Measurement; Pain, Postoperative

The analgesic profile of epidural nalbuphine for postoperative pain relief and the impact of local anaesthetic choice upon this profile was investigated in 58 patients undergoing elective Caesarean delivery under epidural anaesthesia. Patients were randomized to receive either lidocaine 2% with 1:200,000 epinephrine or 2-chloroprocaine 3% for perioperative anaesthesia, followed by either 10, 20, or 30 mg of epidural nalbuphine administered at the first complaint of postoperative discomfort. Postoperative analgesia was quantitated on a visual analogue (VAS) scale, and by the time from the epidural opioid injection until the first request for supplemental pain medication. The duration of analgesia after lidocaine anaesthesia followed by 10, 20 or 30 mg nalbuphine was 77 (53-127) min, 205 (110-269) min, and 185 (116-241), respectively (median, 95% confidence interval, P less than 0.01, 20 and 30 mg vs 10 mg). Following 2-chloroprocaine anaesthesia, VAS remained consistently elevated: the median duration of analgesia was only 30-40 min and did not differ among the three doses of nalbuphine. Side-effects consisted only of somnolence, and were noted only following lidocaine anaesthesia. Somnolence was observed in 0, 20% and 50% of those receiving 10 mg, 20 mg and 30 mg of nalbuphine respectively (NS). No evidence of respiratory depression was noted in any patient. It is concluded that 20 or 30 mg of epidural nalbuphine provides analgesia for only two to four hours following Caesarean delivery with lidocaine anaesthesia, but anaesthesia with 2-chloroprocaine resulted in minimal or no analgesia from this opioid. Nalbuphine appears to be a disappointing agent for epidural use after Caesarean delivery.

Topics: Adult; Analgesia, Epidural; Analgesia, Obstetrical; Anesthesia, Epidural; Anesthesia, Obstetrical; Anesthetics, Local; Cesarean Section; Dose-Response Relationship, Drug; Female; Humans; Lidocaine; Nalbuphine; Pain Measurement; Pain, Postoperative; Pregnancy; Procaine; Sensation; Sleep; Time Factors

The analgesic efficacy and side-effects of epidural nalbuphine (0.075-0.3 mg.kg-1) were compared with epidural morphine 0.1 mg.kg-1 in a randomised double-blind study in post-thoracotomy patients. The drugs were administered via a lumbar epidural catheter one hour before the end of surgery. Efficacy was assessed using visual analogue pain scores and supplementary iv fentanyl requirements; respiratory function was studied with an inductive plethysmograph and arterial blood gas analysis; and plasma nalbuphine levels were measured. Pain scores and fentanyl supplementation were lowest in the morphine group (P less than 0.01). No dose-response effect was apparent in the nalbuphine dose-range studied. Respiratory depression was more common in patients receiving morphine (higher mean PaCO2P less than 0.01, more frequent apnoeas greater than 15 sec P less than 0.05, and incidence of PaCO2 greater than 50 mmHg requiring naloxone P less than 0.01). There were no differences in haemodynamic variables, sedation, or other side-effects among the groups. The pharmacokinetic profile of epidural nalbuphine was similar to that seen with rapid iv injection. The results indicate that, relative to morphine, lumbar epidural nalbuphine is an ineffective analgesic after thoracotomy. Despite the lower incidence of respiratory depression its administration by this route cannot be recommended.

Topics: Adult; Aged; Analgesia, Epidural; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Nalbuphine; Pain, Postoperative; Thoracotomy

This randomized, double-blind study compared the analgesic and respiratory effects of lumbar epidural morphine 5 mg, nalbuphine 10 mg, and nalbuphine 20 mg in repeated doses in patients after thoracotomy; the first dose was administered intraoperatively. Pre-and postoperative monitoring included continuous pulse oximetry, respiratory inductance plethysmography, and repeated arterial blood gas analysis. Postoperatively, visual analogue pain scores, somnolence scores, respiratory rate, and arterial blood gases were determined for 16 h. Preoperatively, episodes of apnea were common during sleep but were not associated with low hemoglobin oxygen saturation or increased arterial carbon dioxide tension (PaCO2). During sleep, some otherwise normal patients had increased PaCO2, and 2 of 15 patients had episodes of hemoglobin oxygen saturation of less than 90%. Postoperatively, 1 and 2 h after arrival in the recovery room, patients who received morphine had lower pain scores than did those who received nalbuphine 10 or 20 mg (P less than 0.05). All 6 patients who received morphine had satisfactory analgesia. Two of 4 patients who received nalbuphine 10 mg and all 5 who received nalbuphine 20 mg were withdrawn from the study because of inadequate analgesia (morphine vs. nalbuphine 10 mg, not significant; morphine vs. nalbuphine 20 mg, P less than 0.01). Two patients who received morphine had persistently increased PaCO2 postoperatively. Two patients who received morphine had episodes of apnea and slow respiratory rate, which were most frequent 6 h after arrival in the recovery room. We conclude that lumbar epidural nalbuphine does not provide adequate analgesia after thoracotomy.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Double-Blind Method; Female; Humans; Injections, Epidural; Male; Middle Aged; Morphine; Nalbuphine; Oximetry; Pain, Postoperative; Plethysmography; Respiration; Thoracotomy

In a double-blind study the relative postoperative respiratory and analgesic effects of perioperatively administered nalbuphine and fentanyl were compared in 60 females undergoing gynecological surgery under i.v. anesthesia. One milliliter (10 mg) nalbuphine was considered equipotent to 1 ml (100 micrograms) fentanyl. In the recovery period pain was assessed by visual analog score (VAS) and recovery by Pegboard scoring. Respiratory function was evaluated by continuous monitoring of respiratory frequency and end-tidal CO2 (ETCO2) and by frequent arterial blood gas analyses. The total volume of analgesic required for surgical analgesia was similar in the two groups. Patients in the nalbuphine group showed mild to moderate increases in pulse rate during the intubation phase and in blood pressure during surgery. Fentanyl was more effective in suppressing these cardiovascular responses. Within the first 15 min following recovery, increasing PaCO2 and ETCO2 as well as respiratory rates below 10/min were noted in 8 patients, who all belonged to the fentanyl group; in 4 of these patients i.v. naloxone had to be administered to reverse respiratory depression. Prolonged sedation was a common feature in patients receiving nalbuphine. It was concluded that fentanyl was superior to nalbuphine in attenuating the pressor responses to intubation and surgery. However, fentanyl was associated with respiratory depression in a considerable number of patients. The quality and duration of postoperative analgesia were similar in the two groups.

Topics: Adolescent; Adult; Aged; Anesthesia Recovery Period; Anesthesia, Intravenous; Blood Pressure; Carbon Dioxide; Double-Blind Method; Female; Fentanyl; Humans; Intraoperative Care; Middle Aged; Morphinans; Nalbuphine; Pain Measurement; Pain, Postoperative; Pulse; Random Allocation; Respiration

Postoperative analgesia in infants and young children is a topic of growing interest in pediatric anesthesia. Two systems measuring postoperative pain in this group of patients have been offered recently: CHEOPS (Childrens Hospital of Eastern Ontario Pain Scale) by McGrath et al. and OPS (Objective Pain Scale) by Hannallah et al. and Broadman et al. [3, 7, 8]. Both systems are economical and not reactive, but their validity is not satisfying. The validity of CHEOPS is based on the statements of experienced nurses, using the method of convergent validation by an expert's assertion. Hannallah and Broadman et al. judged the validity of their objective pain scale for infants and young children by statements of juveniles between 13 and 18 years of age. McGrath et al. accepted the item of spontaneous verbal communication as useful in the CHEOPS, although no such verbal comment occurred in their study on interrater and inter-item correlations. The aim of the present study was to evaluate the statistical qualification of items for measurements of the intensity of postoperative pain in young children and to investigate some aspects of their validity. MATERIAL AND METHODS. The study was performed in 54 children of ASA groups I and II aged 29.2 +/- 10.7 months. They were included in the study if they were pain-free before the operation and had no signs and symptoms of neurologic disease. The following operations were accepted: herniorrhapy, orchidopexy, circumcision, and umbilical herniorrhaphy. Premedication and general anesthesia were standardized. The patients were premedicated with midazolam 0.5 mg/kg rectally and subsequent intramuscular injections of ketamine 2.0 mg/kg with atropine 0.01 mg/kg. Anesthesia was induced and maintained by inhalation of oxygen/nitrous oxide and halothane (FiO2 0.3). All children were intubated and ventilation was controlled during the operation. After the operation and under steady-state anesthesia with 0.5 vol.% halothane and spontaneous respiration, the children received either nalbuphine 0.1 mg/kg, piritramide 0.1 mg/kg, or placebo in a randomized and double-blind manner. Respiratory and circulatory parameters were recorded for 15 min before anesthesia was discontinued. Five minutes after halothane had been discontinued the first measurement of the childrens' behavior was started with four subsequent measurements at fixed time intervals of 15 min. The measuring system was based on the six items of CHEOPS complemented by five ite

Topics: Child, Preschool; Double-Blind Method; Humans; Infant; Isonipecotic Acids; Morphinans; Nalbuphine; Pain Measurement; Pain, Postoperative; Pirinitramide; Randomized Controlled Trials as Topic; Reproducibility of Results

As most patients undergoing pulmonary surgery by postero-lateral thoracotomy have decreased preoperative pulmonary function, efficient postoperative analgesia is mandatory. Nalbuphine, a new agonist-antagonist opioid analgesic, and nefopam were compared in a double blind trial involving 60 patients. Intravenous injections of 0.3 mg.kg-1 of either drug were started when the patient evaluated his pain as being above 60 mm on a visual scale graduated from 0 to 100 mm. Repeated injections were carried out at the same dose, at the patient's request, after a minimal interval of 3 h for nalbuphine, and 6 h for nefopam. Analgesia was assessed by the visual scale, and by the patient's verbal appraisal. The respiratory and cardiovascular repercussions were evaluated clinically, and by monitoring breathing rate, blood gases, systolic and diastolic blood pressures, heart rate, and consciousness. Nalbuphine provided a convenient analgesia to all patients whereas analgesia with nefopam was insufficient in 15 out of 30 patients. No significant respiratory depression with either drug occurred. Nefopam led to a 30% increase in heart rate for one hour (p less than 0.01). Whereas patients given nalbuphine were more drowsy, although easily aroused, (p less than 0.001), nefopam was responsible for adverse effects (sweating, nausea, tachycardia with pallor, vertigo, malaise) requiring the exclusion of 7 patients from the study. Nalbuphine, although not ideal, would therefore seem to be a better analgesic than nefopam in thoracotomy patients.

Topics: Aged; Clinical Trials as Topic; Double-Blind Method; Female; Hemodynamics; Humans; Male; Middle Aged; Morphinans; Nalbuphine; Nefopam; Oxazocines; Pain Measurement; Pain, Postoperative; Postoperative Care; Respiration; Thoracotomy

The influence of piritramide and nalbuphine versus placebo on the postoperative comfort of 54 children of ASA-group I and II in the age between 1 and 4 years was tested in a randomized double blind trial using the comfort/discomfort scale according to Büttner et al. METHODS. Operations, premedication and anesthesia were standardized. The patients were premedicated with midazolam 0.5 mg/kg rectally and a subsequent i.m. injection of ketamine 2.0 mg/kg with atropine 0.01 mg/kg. Anesthesia was induced and maintained by inhalation of oxygen/nitrous oxide and halothane (FiO2 = 0.3). All children were intubated and ventilation was controlled during the operation. After the operation, while in steady-state anesthesia with 0.5 vol% halothane and during spontaneous respiration the children received either piritramide (n = 17) or nalbuphine (n = 20) at a dose of 0.1 mg/kg, or placebo (n = 17) i.v. Respiratory and circulatory parameters were recorded for 15 min before the end of anesthesia. At 5 min after halothane had been discontinued the first measurement of the children's behavior was started, with 4 subsequent measurements at fixed time intervals of 15 min. The measuring system included the following 6 scaled items: wake-up reaction, methodical defense against stimuli, crying, facial expression, posture of the torso, posture of the legs. In addition, the waking state was scored at the same time intervals as awake, arousable, or not arousable. During the 1-h observation period all children who seemed to feel uncomfortable received midazolam i.v. at a maximal dose of 2 mg. Up to 24 h the required supplemental analgesics were noted, as were episodes of psychomotor agitation and vomiting. Written consent was obtained from the ethical committee and the children's parents. The results were tested in a 2-factorial analysis of variance (treatment factor: drugs; within-subject factor; repeated measurements). RESULTS. The 3 groups were considered to be comparable in terms of age, body weight, kind and duration of operation and circulatory values. The use of supplementary analgesics showed a significant effect in the treatment factor and in the within-subject factor: during the 1-h observation period the placebo group received midazolam significantly more often (64.7%) than the piritramide group (5.9%) or the nalbuphine group (35%). During the following 7 h 29.4% of the children of the placebo group required supplementary analgesics (piritramide: 23.5%; nalbuphine: 20%).

Topics: Child, Preschool; Double-Blind Method; Humans; Infant; Isonipecotic Acids; Morphinans; Nalbuphine; Pain, Postoperative; Pirinitramide; Randomized Controlled Trials as Topic

Nalbuphine is a new partly agonistic antagonistic opioid, that may offer some advantages especially in postoperative pain relief. We compared meperidine (1 mg kg-1) in 100 patients and nalbuphine (0.3 mg kg-1) in 70 patients, administering both agents intravenously after gynaecological operations. Standardised halothane anaesthesia without any opioid was used. After arrival in the recovery room, vigilance (sedation), quality and duration of pain relief were measured by different methods at four different times (0, 15, 30, and 60 minutes). Sedation was significantly more pronounced in the nalbuphine group, but no difference could be found in pain relief and duration between both groups. 6 patients of the n-group showed a short lasting wake-up reaction due to receptor antagonism. 36 patients had to be reinjected at the end of the first hour. We consider nalbuphine to be a safe opioid, however, the marked sedation should be taken into account.

Topics: Adult; Female; Humans; Hysterectomy, Vaginal; Meperidine; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative

The efficacy of nalbuphine, an agonist/antagonist opioid, in preventing respiratory depression from epidural morphine analgesia after thoracotomy, was assessed in a randomized double-blind placebo controlled trial. After a standardized general anaesthetic and 0.15 mg.kg-1 of epidural morphine, patients received a bolus and then a 24 h infusion of nalbuphine (200 micrograms.kg-1 + 50 micrograms.kg-1.hr-1, 100 micrograms.kg-1 + 25 micrograms.kg-1.hr-1, or 50 micrograms.kg-1 + 12.5 micrograms.kg-1.hr-1) or placebo. Blood gases, analgesia, sedation, side effects, and blood nalbuphine concentrations were assessed every two hours for the next 24 h. Fifty-three per cent of placebo-treated patients had a PaCO2 greater than 50 mmHg and 89 per cent of these received naloxone. A 200 micrograms.kg-1 bolus of nalbuphine followed by a 50 micrograms.kg-1.hr-1 infusion achieved a mean steady state blood level of 38.2 ng.ml-1 and prevented CO2 retention greater than 50 mmHg in all but two patients, neither of whom required naloxone. There was no difference in the incidence of side effects among groups, and analgesia appeared to be unaffected by nalbuphine.

Topics: Adult; Aged; Analgesia, Epidural; Carbon Dioxide; Double-Blind Method; Female; Humans; Infusions, Intravenous; Male; Middle Aged; Morphinans; Morphine; Nalbuphine; Pain, Postoperative; Placebos; Respiratory Insufficiency; Thoracotomy

Two groups of 40 patients undergoing hip replacement received either nalbuphine 0.3 mg kg-1 or morphine 0.15 mg kg-1 i.m. on up to three occasions: 1 h before operation, as soon as requested after operation, and 3 h subsequently if required. Pain intensity was assessed by the patient as severe, moderate or none, and pain relief by a "blind" nurse observer as slight, moderate or complete. Assessments of pain and sedation were carried out at 30-min intervals for 2 h and at 1-h intervals thereafter for up to 6 h. Six patients who received nalbuphine and eight who received morphine before operation required no postoperative analgesia. Ten patients in the nalbuphine group and two in the morphine group failed to obtain adequate pain relief (P less than 0.05) and were given i.v. morphine.

Topics: Analgesia; Double-Blind Method; Hip Prosthesis; Humans; Injections, Intramuscular; Morphinans; Morphine; Nalbuphine; Pain, Postoperative; Random Allocation

The side-effects of two opioid agonist-antagonists, nalbuphine and pentazocine, were assessed when used for patient-controlled postoperative analgesia. Forty ASA I or II patients scheduled for upper abdominal surgery were randomly allocated to two equal groups. The anaesthetic technique was the same for all the patients: premedication with atropine and diazepam, induction with thiopentone and suxamethonium and maintenance with fentanyl, pancuronium, nitrous oxide and halothane. Patient-controlled computer assisted analgesia (On-Demand Analgesia Computer) was started in the recovery room at least 2 h after the last administration of fentanyl. The parameters used were: a routine hourly dose (the half of that received during the previous hour), with on demand delivery of nalbuphine (15 micrograms.kg-1) or pentazocine (45 micrograms.kg-1) aliquots respectively, with a refractory period between two demands of 4 min and a total hourly maximum dose of 16 mg and 48 mg respectively. The following parameters were measured before the start of self-administration, and every hour afterwards for 24 h: systolic (Pasys) and diastolic blood pressures, heart rate, pressure-rate product (PRP), respiratory rate, end-tidal CO2 and pain (by way of a three point scale). Analgesia was assessed on a four-point scale every 6 h. The total doses of nalbuphine and pentazocine administered were 94 +/- 43 mg and 251 +/- 150 mg respectively. The only parameters significantly different between the two groups were Pasys and PRP, being higher in the pentazocine group. There were no significant differences in the side-effects (drowsiness, nausea, vomiting, headache, amnesia, logorrhoea and urine retention). All patients in both groups were satisfied with this technique.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Blood Pressure; Clinical Trials as Topic; Heart Rate; Humans; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Pentazocine; Self Administration

Pharmacokinetic data and analgetic potency of nalbuphine hydrochloride (Nubain) under conditions of postoperative respiratory treatment and repeated dosage was investigated in a multicenter study. Patients received 20 mg nalbuphine intravenously at intervals of 3 h. Blood samples for analysis of nalbuphine plasma concentration were taken after the first injection, immediately before further medication and after the last one. Data were fitted to 2-compartment model using non-linear fit procedures. The half-life time in plasma was slightly shorter than in other studies, while the peak plasma concentrations were comparable with other results in the literature. There was no cumulation of the substance found in this study. Clinically the antagonistic effect of nalbuphine was mainly observed after neuroleptic anaesthesia. In these cases additional injections of further analgetic and sedative drugs were necessary. The clinical effect was mostly considered to be good or satisfactory. Less satisfactory effects were due to the 3 h time distance between repeated dosage. Shorter intervals could be discussed and used because of the absence of cumulation of nalbuphine in this study.

Topics: Adolescent; Adult; Female; Humans; Male; Morphinans; Multicenter Studies as Topic; Nalbuphine; Pain, Postoperative; Postoperative Period

Topics: Aged; Cardiovascular Diseases; Digestive System Diseases; Double-Blind Method; Female; Humans; Male; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Pentazocine; Randomized Controlled Trials as Topic

A group of 40 women having undergone abdominal gynecological operations were studied for the comparative evaluation of nalbuphine and morphine. The analgetics were used to relieve postoperative pain in the technique of double blind trial. 20 women were administered 20 mg of nalbuphine and 20 women were administered 10 mg of morphine. Within 6 hours following the administered of each of the drugs, the authors evaluated the analgetic effectiveness, haemodynamic, ventilatory and gasometric parameters. Most of the women showed satisfactory and comparable analgetic effectiveness of the two drugs for six hours. No influence was found of any of the analgetics on the physiological parameters examined. The frequency and intensification of side-effects were the same both after administering nalbuphine and morphine. In the authors' opinion, in a proper dose, nalbuphine is an analgetic equal to morphine with respect to analgetic effectiveness and time of pharmacological action.

Topics: Adult; Double-Blind Method; Female; Genitalia, Female; Humans; Middle Aged; Morphinans; Morphine; Nalbuphine; Pain, Postoperative

Topics: Adult; Butorphanol; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Injections, Epidural; Male; Meperidine; Middle Aged; Morphine; Nalbuphine; Narcotic Antagonists; Narcotics; Pain, Postoperative

The aim of the study was a comparison of the side-effects and efficacy of nalbuphine, piritramide, and placebo in patients during recovery from halothane anesthesia.. Neurosurgical (vertebral surgery) and otolaryngological patients (surgery of face and neck) were operated under halothane anesthesia. Postoperatively 20 patients received 20 mg nalbuphine, 21 patients 15 mg piritramide, and 19 patients 0.9% NaCl for pain therapy in a randomized and double-blind manner. Respiratory function was monitored by blood gas analysis, hemodynamic function by noninvasive measurements. The analgetic and sedative effects were estimated by the patients (visual analog scale) and the investigator (4-point scale). If the treatment was ineffective, the study was interrupted and a known analgesic was prescribed.. The noninvasively measured hemodynamic parameters were unchanged. On the other hand, in the nalbuphine group mean arterial pCO2 increased significantly (max. 55.4 mmHg after 20 min), over the piritramide group (max. 51.2 mmHg before treatment) and the placebo group (max. 55.1 mmHg before treatment). Drowsiness, in 8 patients in each of the treatment groups and 3 patients in the placebo group, was the most frequent side-effect. After nalbuphine the pain threshold was significantly higher than after treatment with piritramide and placebo. The study was interrupted because of inefficacy in no patients from the nalbuphine group, 2 patients from the piritramide group, and 6 patients from the placebo group. There were no differences in the sedative effects.. Nalbuphine seems to have better analgesic effects then piritramide. Both cause no hemodynamic alterations.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Anesthesia, Endotracheal; Blood Pressure; Cervical Vertebrae; Clinical Trials as Topic; Halothane; Humans; Intervertebral Disc Displacement; Isonipecotic Acids; Lumbar Vertebrae; Morphinans; Nalbuphine; Otorhinolaryngologic Diseases; Oxygen; Pain Measurement; Pain, Postoperative; Pirinitramide; Random Allocation

Little is known about the effects of mixed opioid analgesics on gastrointestinal propulsion. In 20 patients, nalbuphine (0.1 mg/kg) was given after routine neuroleptanesthesia consisting of 70 micrograms/kg droperidol, 7 micrograms/kg fentanyl, and N2O/O2 (3:1) ventilation, to study its effect on gastrointestinal motility in the postoperative period. For comparison, another group of patients (n = 20) undergoing similar interventions received placebo (0.9% NaCl) at the end of the procedure. Gastrointestinal transit time was determined by measuring the exhaled H2 concentration following gastric lactulose administration. As lactulose is degraded only in the cecum, resulting in the release of hydrogen, the arrival of the polysaccharide at the terminal ileum could thus be determined. Compared to placebo, gastrointestinal transit was significantly longer in patients after nalbuphine (mean transit time 270 min vs 380 min). Pain estimation by visual analogue scale (VAS 0-10) suggested an antagonistic effect at the 10th and 20th min postoperatively, as pain scores in the nalbuphine group were higher when compared to placebo (3.5 vs 1.8 and 2.5 vs 1.4). There was a similar pain score in both groups (1.3 vs 1.4) 30 min after drug administration. However, there was significantly better pain relief after nalbuphine (0.7 vs 1.4 and 0.7 vs 1.1) in the late postoperative period (120th and 240th min). When given after potent opioids, it must be borne in mind that the antagonistic effect of nalbuphine is initially apparent. The agonistic potency of the compound will come into effect around the 30th min post-injection. Delayed gastrointestinal transit after nalbuphine is explained by agonist-like effects on peripheral opioid receptors in the gut.

Topics: Adult; Clinical Trials as Topic; Female; Fentanyl; Gastrointestinal Transit; Humans; Male; Middle Aged; Morphinans; Nalbuphine; Neuroleptanalgesia; Pain, Postoperative; Placebos; Prospective Studies; Random Allocation; Time Factors

A randomized, double-blind comparison of nalbuphine 30 mg or 60 mg by mouth and dihydrocodeine 30 mg by mouth was conducted in 75 patients with moderate to severe pain after surgery for dental extractions under general anaesthesia. A significant reduction in pain intensity followed each treatment and persisted throughout the 4-h observation period after nalbuphine, but only for 3 h after dihydrocodeine was given. Reduction in pain intensity was significantly greater 2, 3 and 4 h after the use of nalbuphine 60 mg than following dihydrocodeine 30 mg, and the mean total pain intensity difference was greater following nalbuphine 60 mg than following dihydrocodeine. Nalbuphine 60 mg effectively provided complete or good pain relief in more than 50% of the patients and only three patients in this group required additional analgesia during the period of observation, compared with nine patients in each of the other groups. However, the patients who received nalbuphine 30 mg had a significantly higher mean pain intensity before treatment than those in the other groups. The side-effects encountered were those typical of opioid medication; there were no statistically significant differences between the groups.

Topics: Administration, Oral; Adolescent; Adult; Anesthesia, Dental; Anesthesia, General; Clinical Trials as Topic; Codeine; Double-Blind Method; Female; Humans; Male; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Random Allocation; Time Factors; Tooth Extraction

The effect of nalbuphine on the respiratory depression, pruritus and analgesia induced by epidural morphine was determined in a randomized, prospective, double-blind, placebo-controlled fashion. Twenty ASA physical status I women received 0.1 mg.kg-1 epidural morphine at induction of general anaesthesia for elective total abdominal hysterectomy. Group 1 (n = 14) received 0.3 mg.kg-1 nalbuphine intravenously six hours after the epidural morphine administration. Group 2 (n = 6) received saline. Prior to agent administration, six patients from the nalbuphine group and four patients from the saline group had respiratory depression indicated by a PaCO2 greater than 45 mmHg. After nalbuphine administration the PaCO2 (mean +/- SE) decreased from 49.5 +/- 1.2 mmHg to 42.5 +/- 0.7 mmHg (p less than 0.005) while there was no significant change after saline administration. Nine of the 14 patients receiving nalbuphine appeared to become more sedated, despite an improvement in ventilation. Pruritus was antagonized by 0.1 mg.kg-1 nalbuphine (p less than 0.006). There was no reversal of analgesia after administration of 0.3 mg.kg-1 nalbuphine.

Topics: Adult; Analgesia, Epidural; Carbon Dioxide; Depression, Chemical; Double-Blind Method; Female; Humans; Hysterectomy; Morphinans; Morphine; Nalbuphine; Pain Measurement; Pain, Postoperative; Prospective Studies; Pruritus; Random Allocation; Respiration

A randomised, double blind study was conducted to compare the efficacy and safety of nalbuphine or pentazocine with midazolam in patients undergoing minor oral surgery under local analgesia. Forty patients, aged between 17 and 48 years and in American Society of Anesthesiologists A.S.A. Class I participated. The results confirmed that the use of either nalbuphine (0.2 mg/kg) or pentazocine (0.5 mg/kg) allowed for a significant reduction in the mean dosage of midazolam required to produce satisfactory sedation when compared with trials where midazolam was used alone. Thus a mean midazolam, 0.087 mg/kg (nalbuphine group) or 0.081 mg/kg (pentazocine group) was required compared with 0.17 mg/kg (Aun et al., 1984) and 0.19 mg/kg (Skelley et al., 1984). Inadvertent overdosage with midazolam is prevented as the onset of sedation and its end-point are more obvious. No adverse cardiovascular or respiratory side effects were noted. The recovery rate for both groups was similar. Ninety-five per cent (39 of 40) of patients were able to walk unaided at 2 h post operation. At this time significantly more patients in the nalbuphine group were pain free (p less than 0.001). Both combinations provided excellent operating conditions with a high degree of safety and high patient acceptability. As the nalbuphine group enjoyed a more comfortable post-operative period this combination is favoured.

Topics: Adolescent; Adult; Anesthesia Recovery Period; Anesthesia, Dental; Double-Blind Method; Female; Humans; Hypnotics and Sedatives; Injections, Intravenous; Male; Midazolam; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Pentazocine; Preanesthetic Medication

Nalbuphine and fentanyl were compared as analgesic components of intravenous conscious sedation with diazepam in a double-blind, prospective trial of 50 patients undergoing elective oral surgery. Subjects were evaluated for intensity of pain, pain relief, sedation, anxiety, recall, and vital signs at systematic observation points intraoperatively and postoperatively. At the conclusion of surgery, 88% who received nalbuphine and 87% treated with fentanyl indicated complete pain relief. One observed adverse reaction was attributed to the combination of fentanyl and the sedative component diazepam. No statistically significant differences were observed between nalbuphine and fentanyl treatments.

Topics: Adult; Anesthesia, Dental; Diazepam; Double-Blind Method; Drug Therapy, Combination; Evaluation Studies as Topic; Female; Fentanyl; Humans; Infusions, Intravenous; Male; Middle Aged; Morphinans; Nalbuphine; Pain Measurement; Pain, Postoperative; Preanesthetic Medication; Prospective Studies

A double blind randomized study was done to compare Nalbuphine 20 mg I.M. to pentazocine 30 mg I.M. for postoperative pain relief after orthopedic surgery. This dose of pentazocine was choosen according to reports in the literature and to our standard practice. Sixty patients entered the study and were observed regularly till up 6 h post injection. The test drug was given when a pain score of 6 was shown on a VAS from 0 to 10. Onset, duration and quality of pain relief were significantly superior for nalbuphine with 50% of the patients still having no or only moderate pain at the end of the observation period. Cardiovascular and side effect were in both groups minor.

Topics: Adult; Double-Blind Method; Female; Humans; Male; Middle Aged; Morphinans; Nalbuphine; Orthopedics; Pain, Postoperative; Pentazocine; Random Allocation

A double-blind investigation was undertaken to compare the efficacy of nalbuphine and fentanyl in the prevention of pain after day case termination of pregnancy. Forty patients were allocated randomly to receive nalbuphine 0.25 mg/kg or fentanyl 1.5 micrograms/kg immediately before induction of anaesthesia. The patients completed scores for pain and nausea, and performed a reaction time test to assess recovery. An observer assessed patient appearance at 1, 2 and 4 hours postoperatively. Patients who received nalbuphine had significantly lower pain scores at 1 hour (p less than 0.01) and 2 hours (p less than 0.05) and required significantly (p less than 0.05) less postoperative analgesia. No significant differences were found between the groups for incidence of nausea or for observer assessment of appearance. There was some evidence of psychomotor impairment at 2 hours in the nalbuphine group. Freedom from Controlled Drug Act regulations and improved analgesia with nalbuphine, render it more satisfactory for day case surgery than the more commonly used fentanyl.

Topics: Abortion, Induced; Adolescent; Adult; Ambulatory Surgical Procedures; Anesthesia Recovery Period; Anesthesia, General; Anesthesia, Obstetrical; Double-Blind Method; Female; Fentanyl; Humans; Morphinans; Nalbuphine; Pain, Postoperative; Pregnancy

A double-blind investigation was conducted to compare nalbuphine with morphine for the control of pain after unilateral orchidopexy. Fifty boys under 11 years of age were allocated randomly to receive intramuscular nalbuphine 0.2 mgkg-1 or morphine 0.2 mgkg-1 immediately after induction of anaesthesia. Pain was assessed on a three-point scale, 1, 2 and 4 h after injection and on the morning following operation. Side-effects were also recorded. There were no significant differences between the two drugs in either the provision of analgesia, or the incidence of the principal side-effects of vomiting and sweating. There was a high incidence of vomiting in both groups. Nalbuphine is a satisfactory alternative to morphine for post-orchidopexy pain and may offer the advantages of greater safety and convenience.

Topics: Child; Clinical Trials as Topic; Cryptorchidism; Double-Blind Method; Humans; Male; Morphinans; Morphine; Nalbuphine; Pain, Postoperative; Random Allocation

It has been suggested in various studies that the opiate agonist/antagonist nalbuphine (Nubain) provides for effective reversal of the respiratory depression after fentanyl while maintaining postoperative analgesia. We tested this hypothesis in a relatively large number of patients. The study consisted of two parts: one randomized open, the other randomized double-blind, each with 150 ASA I or II patients aged 18 to 65 years. After premedication with atropine 0.5 mg and flunitrazepam 0.5 mg, anaesthesia was induced with flunitrazepam 0.5 mg, fentanyl 0.1 mg, and etomidate 10 mg and maintained with N2O/O2, 2/1, and additional increments of 0.1 mg fentanyl as required. Relaxation for intubation and surgery was obtained with vecuronium, atracurium, or pancuronium depending on the expected duration of anesthesia. After the operation the patients were extubated and the residual effects of fentanyl antagonized with naloxone 0.05 mg or nalbuphine 10 mg or 20 mg i.v. (randomized open or double-blind). The patient data and fentanyl dosages are given in Table 1. Postoperative pain was assessed by the time interval between administration of the opiate antagonist and the requirement for the first analgesic medication. Figures 1a and b and Table 2 indicate that after nalbuphine 20 mg the first analgesic was required significantly later than after naloxone 0.05 mg (median 115 or 123 min after nalbuphine 20 mg vs 56 or 52 min after naloxone 0.05 mg; P less than 0.02). There was no significant difference between nalbuphine 10 mg and naloxone 0.05 mg. The open and double-blind studies gave virtually identical results. Sixty minutes after administration of 20 mg nalbuphine, vigilance was significantly reduced.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Abdomen; Adolescent; Adult; Aged; Anesthesia, Inhalation; Arousal; Clinical Trials as Topic; Dose-Response Relationship, Drug; Double-Blind Method; Fentanyl; Humans; Middle Aged; Morphinans; Nalbuphine; Naloxone; Pain, Postoperative

A double-blind, sex-stratified, study compared the analgesic efficacy and side effects of nalbuphine 10 mg ml-1 (group N) and buprenorphine 0.15 mg ml-1 (group B) administered as a continuous infusion (0.2 ml kg-1/24 h), after abdominal surgery. Patients could request additional i.m. analgesic for pain. The study groups were well matched. The trial was stopped after 55 patients had been studied (nalbuphine 29, buprenorphine 26), because nine patients in the nalbuphine group had inadequate pain relief (P less than 0.01) shortly after surgery (mean 2.5 h). Analysis of the results on an "intention to treat" basis showed that the patients who received buprenorphine had significantly greater pain relief at 1, 3, 6 and 20 h after surgery. Patients who received buprenorphine were assessed by the physiotherapist to have less pain and better chest expansion. More additional analgesic was given to the patients receiving nalbuphine. In the patients receiving buprenorphine, the mean ventilatory rate was less (N = 19 b.p.m., B = 14 b.p.m.) (P less than 0.001) and the increase in PaCO2 was greater (N = 0.5 kPa, B = 1.1 kPa) (P less than 0.001), compared with the value before operation. Side effects were equal, and no serious adverse effects were observed in either group.

Topics: Abdomen; Adolescent; Adult; Aged; Buprenorphine; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Infusions, Intravenous; Male; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Physical Therapy Modalities; Respiration

The analgesic efficacy and side effect profile of nalbuphine 20 mg IV and of nalbuphine 40 mg IV were compared to those of meperidine 75 mg IM in the immediate postoperative period. Pain intensity, pain relief, additional analgesic requirements and the overall acceptability of the treatment were recorded for 150 patients. No significant differences were found between the groups for any of the efficacy variables. Peak analgesic effects occurred at 15 minutes in both nalbuphine groups and at 30 minutes in the meperidine group. The mean time to additional analgesic medication was approximately 207 minutes in each group. The incidence of nausea and vomiting with meperidine was 22 per cent (95 per cent confidence interval 10 to 34 per cent) and with nalbuphine 20 mg the incidence was two per cent (95%CI -2 to 6 per cent). This difference was significant (p less than 0.01). The difference between nalbuphine 40 mg (10 per cent, 95%CI 1 to 19 per cent) and meperidine, was not considered statistically significant (p = 0.17). The analgesic efficacy of nalbuphine 20 mg was indistinguishable from that of nalbuphine 40 mg and from that of meperidine 75 mg. The significantly lower incidence of nausea and vomiting with nalbuphine is a major advantage for a recovery room analgesic.

Topics: Abdomen; Adult; Bone and Bones; Double-Blind Method; Female; Humans; Male; Meperidine; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative

The postoperative treatment of pain in children is often inadequate: Periphal acting analgetics are not sufficient, opioids are believed to be dangerous because of their respiratory depression. Nalbuphine and tramadol are two narcotics with only a few side effects. The aim of this trial was to investigate the efficacy and safety of these drugs in postoperative pain therapy in children aged 1-9 years. 30 children in each group received in a double-blind and randomized manner either 0.15-0.2 mg/kg nalbuphine or 0.75-1.0 mg/kg tramadol im. Pain intensity and sleep-awake behaviour were documented by a visual analogue scale for 24 h. After 1 h 70% of the patients in both groups had no pain and were sleeping. There was no change in heart rate and systolic blood pressure. Only the diastolic blood pressure decreased as did the respiratory rate, while the tcpCO2 estimated in some patients remained constant. Narcotic reinjections were necessary three times in the nalbuphine group and four times in the tramadol group. Typical opioid side effects were found to be equal in both groups.

Topics: Blood Pressure; Body Temperature; Carbon Dioxide; Child; Child, Preschool; Clinical Trials as Topic; Cyclohexanols; Double-Blind Method; Female; Heart Rate; Humans; Infant; Male; Morphinans; Nalbuphine; Pain, Postoperative; Random Allocation; Respiration; Tramadol

This double-blind, randomized, parallel, placebo-controlled study evaluated the analgesic effects of single oral doses of 30 mg nalbuphine, 650 mg acetaminophen, and the contribution of each to the efficacy of their combination in 128 hospitalized patients with postoperative pain. Subjective reports of patients evaluated each hour for 6 hours were used as indices of analgesic response. Both nalbuphine and acetaminophen were significantly superior to placebo for most measures of total and peak analgesia. The interaction contrast between nalbuphine and acetaminophen was not significant for any analgesic measurements, indicating an additive effect of the components. The combination was the most effective treatment, followed by nalbuphine, acetaminophen, and placebo. Effects of the combination were significantly different from those of acetaminophen at 4, 5, and 6 hours and from those of placebo at 1 to 6 hours. There was no significant difference in the frequency or intensity of side effects among the groups. The combination of nalbuphine and acetaminophen appears to be a therapeutically useful combination.

Topics: Acetaminophen; Administration, Oral; Adolescent; Adult; Aged; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Random Allocation

A double-blind comparison of some analgesic and gastrointestinal effects of nalbuphine and pethidine was performed in 28 women undergoing laparoscopic sterilisation. The opioid was given as an initial loading dose prior to the induction of general anaesthesia and further doses were given on demand in the postoperative period to achieve and maintain adequate pain relief. Gastric emptying in the immediate postoperative period was also assessed in each patient by measuring the rate of absorption of orally administered paracetamol. Nalbuphine was equally effective as pethidine as a postoperative analgesic, but may have been a less effective supplement to anaesthesia in the doses used in this study. Gastric emptying was profoundly depressed in all patients irrespective of which analgesic was used.

Topics: Absorption; Acetaminophen; Adult; Animals; Double-Blind Method; Drug Evaluation; Female; Gastric Emptying; Humans; Meperidine; Morphinans; Nalbuphine; Pain, Postoperative; Random Allocation; Vomiting

In a double-blind clinical trial of 48 patients, nalbuphine, morphine, and pethidine were compared by on-demand intravenous analgesia during the first 24 hours after cholecystectomy. Overall pain relief (visual analogue score) was recorded by the patients as 50 (SEM 4) for nalbuphine, 44 (SEM 4) for morphine and 53 (SEM 5) for pethidine. These scores were not significantly different. The mean demand for each drug over the 24-hour period was 70 (SEM 12) mg for nalbuphine, 46 (SEM 6) mg for morphine and 614 (SEM 49) mg for pethidine. Pain on movement, either during deep breathing or turning, was found to be less well controlled after nalbuphine (70, SEM 2), and pethidine (67 SEM 7) than after morphine (52, SEM 5; p less than 0.01). The incidence of side effects was similar with each drug. Nalbuphine is a useful postoperative analgesic, as effective as pethidine. Nalbuphine 15 mg is apparently equipotent with morphine 10 mg or pethidine 120 mg by this mode of administration.

Topics: Adult; Cholecystectomy; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Infusions, Parenteral; Male; Meperidine; Middle Aged; Morphinans; Morphine; Nalbuphine; Pain, Postoperative; Self Administration; Therapeutic Equivalency; Time Factors

Nalbuphine hydrochloride (Nubain; Du Pont Pharmaceuticals), a synthetic agonist-antagonist analgesic, in a dose of 20 mg was compared with pethidine 100 mg in 60 patients after elective surgery in a random double-blind study. Both drugs were given intramuscularly on the first day after surgery. The pain intensity and visual analogue scales would seem to indicate that nalbuphine has a longer duration of action than pethidine (P less than 0,05). The respiration rates in the pethidine group were significantly more depressed 30 minutes after the injection than in the nalbuphine group (P less than 0,05). Nalbuphine caused less depression of both systolic and diastolic blood pressure at both 30 and 60 minutes (P less than 0,001). The results of the study show that nalbuphine, in the dose used here, may prove to be a useful substitute for pethidine.

Topics: Adolescent; Adult; Aged; Blood Pressure; Clinical Trials as Topic; Double-Blind Method; Humans; Meperidine; Middle Aged; Morphinans; Nalbuphine; Orthopedics; Pain, Postoperative; Random Allocation; Respiration

Topics: Adolescent; Adult; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Molar, Third; Morphinans; Nalbuphine; Pain, Postoperative; Pentazocine; Prospective Studies; Random Allocation; Tooth Extraction

A controlled investigation was conducted to compare the effectiveness of morphine and nalbuphine in the prevention of pain and restlessness after tonsillectomy in children. Sixty children between 4 and 12 years old were randomly allocated to receive intramuscular morphine 0.2 mg/kg, nalbuphine 0.3 mg/kg or no medication approximately 5 minutes before the conclusion of surgery. Pain and restlessness were assessed 1 and 2 hours after injection, and side effects were recorded. The assessments were made double-blind. Both nalbuphine and morphine decreased restlessness and pain 1 hour (p less than 0.01) and 2 hours (p less than 0.05) after surgery. No significant differences were found between the two groups of patients who received opioids. Both nalbuphine and morphine caused more drowsiness than placebo 2 hours after surgery (p less than 0.001). Other side effects were uncommon. Nalbuphine may offer advantages compared with morphine in regard to safety and convenience of use for the treatment of post-tonsillectomy pain in children.

Topics: Child; Child, Preschool; Clinical Trials as Topic; Female; Humans; Male; Morphinans; Morphine; Nalbuphine; Pain, Postoperative; Psychomotor Agitation; Tonsillectomy

In a randomized double-blind-study nalbuphine 20 mg i.m. was compared with morphine 10 mg i.m. in 49 patients over the first 48 postoperative hours after hysterectomy. Nalbuphine proved to be a good analgetic, not statistically different from morphine but having statistically significantly fewer side effects.

Topics: Clinical Trials as Topic; Double-Blind Method; Female; Humans; Hysterectomy; Middle Aged; Morphinans; Morphine; Nalbuphine; Pain, Postoperative; Random Allocation

A double-blind study was undertaken to compare nalbuphine, a synthetic partial agonist opiate, with meperidine in providing analgesia in patients following abdominal surgery, using the patient controlled analgesic technique. Both drugs showed a wide variation in demand requirements, but they were equally effective in relieving pain as assessed by the linear analogue technique. Neither drug caused a reduction of respiratory rate. The patient-controlled analgesic technique gave analgesia of good quality and it aided the comparison of the two drugs. However, some of the patients found the technique difficult to manage, and it is expensive and time-consuming. Until further experience is gained with this device its use should be confined to a constant care unit.

Topics: Adult; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Injections, Intravenous; Male; Meperidine; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Self Administration

In a double-blind study using patients' subjective reports as indices of analgesia, the relative analgesic potency of intramuscular and oral nalbuphine was determined in 104 postoperative patients. Effects of single doses of 3 and 9 mg of intramuscular nalbuphine were compared with those of 15- and 45-mg oral doses of nalbuphine by means of a parallel study design (26 patients per treatment group). When both intensity and duration of analgesia are considered (i.e., total analgesic effect), oral nalbuphine is 1/4 to 1/5 as potent as intramuscular nalbuphine. In terms of peak effect, however, oral nalbuphine is only 1/10 as potent. The oral/parenteral potency ratio for total effect is close to those obtained by Houde et al. in studies of morphine (1/6), metopon (1/5), hydromorphone (1/5), and oxymorphone (1/6) and suggests that oral nalbuphine undergoes substantial biotransformation on first pass through gut mucosa and liver. Since intramuscular nalbuphine is approximately equipotent to morphine, it should be feasible to equal the analgesia induced by the usual intramuscular doses of morphine with reasonable oral doses of nalbuphine. Although nalbuphine is a mixed agonist/antagonist analgesic, no psychotomimetic reactions were observed.

Topics: Administration, Oral; Clinical Trials as Topic; Dose-Response Relationship, Drug; Double-Blind Method; Humans; Injections, Intramuscular; Morphinans; Nalbuphine; Pain, Postoperative; Time Factors

In a double-study, using patients' subjective reports as indices of analgesia, the relative analgesic potency of intramuscular nalbuphine and morphine was determined in 56 postoperative patients. A total of 28 crossover comparisons (utilizing the twin passover, balanced four-point incomplete block design) were performed in two sequentially related experiments, each assay comparing 4 and 8 mg of morphine with either 3 and 6 or 6 and 12 mg of nalbuphine. When both intensity and duration of analgesia are considered (i.e., total analgesic effect), nalbuphine was 0.8 to 0.9 times as potent as morphine. In terms of peak analgesic effect, nalbuphine was 0.7 to 0.8 times as potent. Both the time-effect curves and the relative potency estimates suggest that nalbuphine has a slightly longer duration of action than morphine at doses that are equianalgesic in terms of peak effect. Side effects of the type usually noted after the administration of potent injectable analgesics to postoperative patients were observed after both morphine and nalbuphine. Although nalbuphine is a potent narcotic antagonist, no psychotomimetic reactions were observed.

Topics: Adult; Analgesics; Clinical Trials as Topic; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Injections, Intramuscular; Male; Middle Aged; Morphinans; Morphine; Nalbuphine; Pain, Postoperative; Research Design; Time Factors

One hundred patients, who were in pain during the immediate postoperative period after upper abdominal operations, were included in this double-blind, between-patient, two-dose study. During N2O-O2-halothane-relaxant anaesthesia no analgesics were given. The patients received 0.07 mg/kg or 0.14 mg/kg of nalbuphine or 0.3 mg/kg or 0.6 mg/kg of pentazocine by intravenous injection. Pain and side effects were assessed for 4 h after administration of the test drug, or until the pain returned to the pre-injection level, when a conventional analgesic was given. The onset of pain relief was similar and the peak effect occurred about half an hour after the injection after both drugs. On a milligram basis, nalbuphine seemed to be about three times as potent as pentazocine. The duration of action seemed to be slightly longer after nalbuphine, but 2 1/2 hrs. after the injection the pain had returned to preinjection level in 2/3 of the patients, even after the higher doses of both drugs. Except for sleepiness, there were few side effects and they were similar after both drugs. No psychotomimetic effects were observed.

Topics: Adult; Aged; Chemical Phenomena; Chemistry; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Injections, Intravenous; Male; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Pentazocine

This retrospective observational study aims to investigate the patient-controlled intravenous analgesia (PCIA) of dexmedetomidine (DEX) with nalbuphine (NAL) versus sufentanil (SUF) for post-cesarean delivery management. A total of 300 women were evaluated who underwent cesarean section surgery with combined spinal-epidural anesthesia. After surgery, all patients were connected to a patient-controlled analgesia pump. The PCIA protocol was programmed with 0.11 μg/kg/h DEX in combination with 0.03 μg/kg/h SUF in Group I (n = 150) or 0.11 μg/kg/h DEX in combination with 0.03 mg/kg/h NAL in Group II (n = 150). There was no significant difference in incision pain and sedation level between the two groups within 48 h after the surgery assessed by visual analog scale (VAS) and Ramsay sedation scale, respectively. However, at 2, 6, 12, and 24 h after surgery, visceral pain at rest and at mobilization was alleviated in the Group II as compared with the Group I with lower VAS scores. Moreover, fewer adverse reactions were found in the Group II when compared with Group I, including postpartum respiratory depression, nausea/vomiting, urinary retention, and cardiovascular events. Overall, there was an increased patient satisfaction in the Group II as compared with the Group I. Based on the results of this study, it seems that adding NAL to PCIA with DEX, as compared to SUF with DEX, have an effect on reducing the intensity of visceral pain after cesarean section with less adverse reactions and higher patient satisfaction.

Topics: Administration, Intravenous; Analgesia, Patient-Controlled; Analgesics, Non-Narcotic; Cesarean Section; Dexmedetomidine; Female; Humans; Nalbuphine; Pain, Postoperative; Pregnancy; Sufentanil; Visceral Pain

Postcesarean pain remains a major complaint from puerperium women who have undergone cesarean section, especially uterine contraction induced visceral pain. The optimal opioid for pain relief after cesarean section (CS) is still unclear. The goal of this study was to compare the analgesic effect of Nalbuphine to Sufentanil in patients who underwent CS.. In this single-center retrospective cohort study, we included patients who received Nalbuphine or Sufentanil Patient-Controlled Intravenous Analgesia (PCIA) after CS between 1 January 2018 and 30 November 2020. Data on a Visual Analog Scale (VAS) at uterine contraction, at rest, and at movement, analgesic consumption, and side effects were collected. We performed logistic regression to identify predictors of severe uterine contraction pain.. A total of 674 patients were identified in the unmatched cohort, and 612 patients in the matched one. Compared to the Sufentanil group, lower VAS-contraction was recorded in the Nalbuphine group in both the unmatched and matched cohorts, the mean difference (MD) on POD1 was 0.35 (95% CI: 0.17 to 0.54,. Compared to Sufentanil, Nalbuphine may provide better analgesia on uterine contraction pain. The superior analgesia may only exhibit in multiparas.

Topics: Analgesia, Patient-Controlled; Analgesics; Analgesics, Opioid; Cesarean Section; Female; Humans; Nalbuphine; Pain, Postoperative; Pregnancy; Retrospective Studies; Sufentanil; Uterine Contraction

Topics: Analgesics, Opioid; Humans; Minimal Clinically Important Difference; Morphine; Nalbuphine; Pain, Postoperative; Treatment Outcome

To evaluate the efficacy of multimodal analgesia of flurbiprofen axetil, nalbuphine hydrochloride and patient controlled intravenous analgesia (PCIA) on inflammatory factor levels and stress response in patients after laparoscopic radical gynecological malignancy surgery. The data of 100 patients admitted to our hospital from May 2019 to May 2020 for laparoscopic radical gynecological malignancy surgery were retrospectively analyzed and they were assigned (1:1) to either an experimental group or a control group according to the alphabetical order of their initials. The experimental group was given preemptive analgesia with flurbiprofen axetil, postoperative analgesia with nalbuphine hydrochloride, and PCIA and the control group was given conventional analgesic measures. The pain scores at 1h, 6h, 12h, 24h and 48h postoperatively in the experimental group were remarkably lower than those in the control group (P<0.001). The experimental group showed significantly lower inflammatory factor levels, pain mediator levels and stress response indexes in the morning before surgery, 1d, and 2d after surgery than the control group (P<0.001). The multimodal analgesia of flurbiprofen axetil, nalbuphine hydrochloride and PCIA can effectively alleviate the stress response and inflammatory response in patients after radical gynecologic malignancy surgery and the patients' pain perception is reduced with a high safety profile.

Topics: Analgesia, Patient-Controlled; Analgesics, Opioid; Female; Flurbiprofen; Genital Neoplasms, Female; Humans; Laparoscopy; Nalbuphine; Pain, Postoperative; Retrospective Studies

Topics: Analgesia, Patient-Controlled; Analgesics, Opioid; Double-Blind Method; Female; Humans; Hysterectomy; Laparoscopy; Nalbuphine; Pain, Postoperative; Sufentanil

This retrospective study evaluated the efficacy, opioid consumption, and safety profile of two patient-controlled intravenous analgesia (PCIA) regimens (sufentanil combined with nalbuphine vs sufentanil alone) after cesarean section (CS).. Parturients (n = 1808) received sufentanil combined with nalbuphine (SN group) or sufentanil alone (S group) as PCIA after CS. The primary outcome was the numeric rating scale (NRS) pain score with movement (NRS-M) at 24 h after CS. Secondary outcomes were NRS scores at rest (NRS-R) at 24 and 48 h after CS, NRS-M at 48 h after CS, cumulative PCIA bolus times, and opioid consumption during the first 24 and 48 h postoperatively, which was measured in morphine-equivalent doses.. Compared with sufentanil alone, sufentanil combined with nalbuphine for PCIA provided superior analgesia in parturient women after CS.

Topics: Analgesia, Patient-Controlled; Analgesics, Opioid; Cesarean Section; Female; Humans; Morphine; Nalbuphine; Pain, Postoperative; Pregnancy; Retrospective Studies; Sufentanil

To evaluate the analgesic effect of ultrasound-guided subcostal anterior quadratus lumborum block (QLB) for laparoscopic radical gastrectomy surgery.. Patients (aged 20-65 years, ASA I - II, and weighing 40-75 kg) scheduled for elective laparoscopic radical gastrectomy were enrolled in the current study. Sixty patients were randomly assigned to two groups by computer-generated randomization codes: an ultrasound-guided oblique subcostal transversus abdominis plane block (TAPB) group (group T, n=30) or an ultrasound-guided subcostal anterior QLB group (group Q, n=30). In both groups, bilateral ultrasound-guided oblique subcostal TAPB and subcostal anterior QLB were performed before general anesthesia with 0.25% ropivacaine 0.5 mL/kg. For postoperative management, all patients received patient-controlled intravenous analgesia (PCIA) with nalbuphine and sufentanil after surgery, maintaining visual analogue scale (VAS) scores ≤4 within 48 h. The intraoperative consumption of remifentanil, the requirement for sufentanil as a rescue analgesic, and the VAS scores at rest and coughing were recorded at 1, 6, 12, 24 and 48 h after surgery. The recovery (extubation time after surgery, first ambulation time, first flatus time and length of postoperative hospital stay) and the adverse events (nausea and vomiting, skin pruritus, respiratory depression and nerve-block related complications) were observed and recorded. The primary outcome was the perioperative consumption of opioids.. Compared with group T, the intraoperative consumption of remifentanil, requirement for sufentanil and the frequency of PCIA were reduced in group Q. Meanwhile, VAS scores at all points of observation were significantly lower in group Q than in group T. Patients in group Q were also associated with shorter time to first out-of-bed activity and flatus, and shorter length of postoperative hospital stay than group T (P<0.05). There were no skin pruritus, respiratory depression or nerve-block related complications in both groups.. Compared with ultrasound-guided oblique subcostal TAPB, ultrasound-guided subcostal anterior QLB provided greater opioid-sparing effect, lower visual analogue scores, and shorter postoperative hospital stay for laparoscopic radical gastrectomy.

Topics: Abdominal Muscles; Adult; Anesthesia, General; Female; Gastrectomy; Humans; Laparoscopy; Male; Middle Aged; Nalbuphine; Nerve Block; Pain Measurement; Pain, Postoperative; Random Allocation; Remifentanil; Ropivacaine; Sufentanil; Ultrasonography, Interventional; Young Adult

Comparing the effect of two different. One hundred and twenty-four patients undergoing laparoscopic cholecystectomy were randomly allocated to receive nalbuphine (group N), oxycodone (group O), and morphine (group M). The three groups were all given intravenous injection (iv.) of 0.15 mg/kg injection before incision and 0.05 mg/kg injection at the end of pneumoperitoneum. The Visual Analogue Scale (VAS) scores (incision, visceral, and shoulder) and Ramsay sedation scores at 1, 2, 4, 8, 12, 16, 20, and 24 hours after surgery, the time of extubation, the incidence of postoperative adverse events, the satisfaction of pain treatment, and the duration of stay after surgery were all recorded.. Compared with group M, the VAS scores of visceral pain at rest decreased in group N and group O at 1-8 h after surgery (. Compared with morphine, prophylactic use of the

Topics: Analgesia; Analgesics, Opioid; Cholecystectomy, Laparoscopic; Female; Humans; Injections, Intravenous; Male; Middle Aged; Morphine; Nalbuphine; Oxycodone; Pain Management; Pain Measurement; Pain, Postoperative; Receptors, Opioid, kappa

The aim of this study was to compare the effects of nalbuphine and sufentanil on the gastrointestinal (GI) tract after laparoscopic surgery for gynaecological malignancies. A total of 100 patients with American Society of Anesthesiologists (ASA) physical status I-II undergoing laparoscopic radical hysterectomy under general anaesthesia were enrolled. The patients were randomized to receive sufentanil (Group S) or nalbuphine (Group N) intraoperatively and postoperatively. The time to first passage of flatus, the time to first defaecation, the time to toleration of diet, the serum gastrin level, and the duration of hospital stay of the groups were compared. The Visual Analogue Scale (VAS) score for postoperative pain, the number of dispensed patient-controlled analgaesics (PCAs), and the prevalence of postoperative nausea, vomiting, and dizziness of the groups were also compared. The time to first passage of flatus (P = .551), time to first defaecation (P = .310), time to toleration of diet (P = .182), serum gastrin level (P = .397), prevalence of postoperative nausea (P = .920) and vomiting (P = .334), number of dispensed PCAs (P = .167), and the duration of hospital stay (P = .482) of the two groups were not significantly different. The VAS scores at 6 hours (P = .008), 12 hours (P = .002), and 24 hours (P = .013) postoperatively were lower in Group N than in Group S. In conclusion, nalbuphine was not associated with improved postoperative GI dysfunction after laparoscopic surgery for gynaecological malignancies, but it was associated with reduced postoperative pain.

Topics: Analgesia, Patient-Controlled; Female; Humans; Male; Middle Aged; Nalbuphine; Pain, Postoperative; Sufentanil

To describe pain assessment, the pattern of analgesic and sedative drug use, and adverse drug reactions in a neonatal intensive care unit (NICU) during the postsurgery phase.. Demographic characteristics, pain scores, and drug use were extracted and analyzed from electronic patient medical files for infants after surgery, admitted consecutively between January 2012 and June 2013.. One hundred and sixty-eight infants were included. Acute (DAN score) and prolonged (EDIN score) pain assessment scores were used in 79% and 64% of infants, respectively, on the 1st day. This percentage decreased over the 7 days following surgery. The weekly average scores postsurgery were 2/15 (±2.2) for the EDIN score and 1.6/10 (±2.0) for the DAN score. The rates of pain control were 88% for the EDIN and 72% for the DAN. The most prescribed opiate drug was fentanyl (98 patients; 58%) with an average dose of 1.8 (±0.6) μg/kg/h. Midazolam was used in 95 patients (56%), with an average dose of 35 (±14) μg/kg/h. A bolus was administered in 7% (±7.4) of the total dose for fentanyl and 8% (±9.3) for midazolam. Similar doses were used in term and preterm neonates. Of 118 patients receiving fentanyl and/or midazolam, 40% presented urinary retention, 28% a weaning syndrome. Paracetamol (155 patients; 92%) and nalbuphine (55 patients; 33%) were the other medications most often prescribed.. The off-label use of fentanyl and midazolam was necessary to treat pain after surgery. Pain assessment should be conducted for all neonates in order to optimize their treatment. Research on analgesic and sedative medicine in vulnerable neonates seems necessary to standardize practices and reduce adverse drug reactions.

Topics: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Cohort Studies; Drug Utilization; Female; Fentanyl; France; Hospitals, University; Humans; Hypnotics and Sedatives; Infant; Infant, Newborn; Intensive Care Units, Neonatal; Male; Midazolam; Morphine; Nalbuphine; Off-Label Use; Pain Measurement; Pain, Postoperative; Retrospective Studies; Substance Withdrawal Syndrome; Sufentanil; Urinary Retention

Nalbuphine is an opioid analgesic agent widely used for control of mild-to-severe pain. However, limited data are available on the pharmacokinetics of this drug in children. The aim of this study was to characterize the population pharmacokinetics of nalbuphine in patients with ages ranging from 1 to 11 yr and to identify patient characteristics partially explaining inter-individual variability in nalbuphine pharmacokinetic parameters.. Twenty-two children were included in this study. They received nalbuphine after surgery by continuous infusion (loading dose, 0.2 mg kg(-1) over 10 min followed by continuous infusion of 0.8 mg kg(-1) over 24 h). If pain relief was not adequate, 0.1 mg kg(-1) bolus doses were allowed in 10 min. Eleven blood samples were collected per patient. The data were analysed by non-linear mixed-effect modelling with the use of a two-compartment structural model.. Twenty patients completed the study. In the final model, the parameter values were standardized for a body weight of 70 kg using an allometric model. Population parameter estimates were: clearance 130 litre h(-1) 70 kg(-1), inter-compartment clearance 75.6 litre h(-1) 70 kg(-1), central volume of distribution 210 litre 70 kg(-1), and peripheral volume of distribution 151 litre 70 kg(-1). In the children of this study, total clearance expressed in litre h(-1) kg(-1) decreased significantly with increasing age and the elimination half-life significantly increased.. The allometric power model developed in this study best reflected the data and may be useful for dose adjustment.

Topics: Aging; Analgesics, Opioid; Body Weight; Child; Child, Preschool; Drug Administration Schedule; Female; Fundoplication; Gastroesophageal Reflux; Humans; Infant; Laparoscopy; Male; Models, Biological; Nalbuphine; Pain, Postoperative; Postoperative Care

Topics: Analgesia, Patient-Controlled; Analgesics, Opioid; Female; Humans; Morphine; Nalbuphine; Pain, Postoperative

Intrathecal opioids have been shown to be safe and effective for postoperative analgesia in healthy children for spinal surgery. The aim of this study was to evaluate the applicability of intrathecal opioids in severely handicapped children scheduled for spinal surgery.. With hospital ethical committee approval, patients with physical states III and IV of the ASA classification requiring spinal surgery were retrospectively studied. In addition to inhalational anesthesia with sevoflurane or intravenous anesthesia using propofol, morphine 20 microg/kgBW and sufentanil 1.5 microg/kgBW were administered intrathecally before surgery. After surgery an infusion of nalbuphine was started. Need for additional intraoperative and postoperative analgesics, time of extubation, postoperative pain scores and p(a)CO2 values as well as adverse effects were recorded.. A total of 28 patients aged from 2.8 to 18.5 years (median 11.6 years) were studied. Immediate tracheal extubation in the operating room was possible in 17 patients and for 11 patients delayed extubation was elected. All patients were extubated within 24 h except for 1 patient who received massive postoperative transfusions. In 26 out of 28 patients (93%) the combination of intrathecal opioids with postoperative nalbuphine provided adequate analgesia. Observed side effects were post-operative nausea and vomiting (PONV), pruritus and moderate hypoventilation. In two patients a change to intravenous morphine therapy was necessary.. The use of intrathecal opioids for perioperative pain control from spinal fusion in severely handicapped children is feasible. Intrathecal opioids provide adequate postoperative analgesia and allow early extubation without persisting relevant respiratory compromise in most of these patients.

Topics: Adolescent; Analgesia; Analgesics, Opioid; Child; Child, Preschool; Disabled Children; Female; Humans; Injections, Spinal; Kaplan-Meier Estimate; Male; Nalbuphine; Pain; Pain Measurement; Pain, Postoperative; Perioperative Care; Postoperative Nausea and Vomiting; Pruritus; Retrospective Studies; Spine

The agonist-antagonist kappa-opioid nalbuphine administered for postoperative pain produces greater analgesia in females than in males. In fact, males administered nalbuphine (5 mg) experience pain greater than those receiving placebo, suggesting the existence of an anti-analgesic effect. These sexually dimorphic effects on postoperative pain can be eliminated by coadministration of a fixed ratio of the prototypical opioid receptor antagonist naloxone with nalbuphine, implying a role for opioid receptors in the anti-analgesic as well as analgesic effects of nalbuphine. In the present study, we further evaluated the role of opioid receptors in the sex-specific effects on pain produced by nalbuphine by coadministering a dose of morphine low enough that it does not produce analgesia. After extraction of bony impacted third molar teeth, nalbuphine (5 mg) was administered alone or in combination with either of 2 low doses of morphine (2 mg or 4 mg). Both doses of morphine reversed nalbuphine-induced anti-analgesia in males, but only the lower dose (2 mg) reached statistical significance. Neither dose affected nalbuphine-induced analgesia in females, and when administered alone in either males or females, morphine (2 mg) had no analgesic effect. Though not observed in females, the effect of morphine in males argues that, like naloxone, low-dose morphine may act as an anti-analgesia opioid receptor antagonist.. Previously, we reported that the nalbuphine produces both analgesic and anti-analgesic effects and that the opioid antagonist naloxone can enhance nalbuphine analgesia by selectively antagonizing the anti-analgesic effect. Here we show that morphine, given in a subanalgesic dose, reverses nalbuphine-induced anti-analgesia in males, perhaps by a similar mechanism.

Topics: Adolescent; Adult; Analgesics, Opioid; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Combinations; Drug Interactions; Female; Humans; Male; Morphine; Nalbuphine; Narcotic Antagonists; Pain, Postoperative; Receptors, Opioid; Sex Characteristics; Sex Factors

Gallbladder stones are very common in patients with sickle cell disease and are the cause of recurrent abdominal pain. Their management has been highly controversial, especially for children. Nonoperated patients and those treated on an emergency basis have a very high rate of morbidity (>50%).. We performed a retrospective review of a series of 29 homozygous SS sickle cell children who underwent laparoscopic cholecystectomy between 1991 and April 1998.. Only in one case a conversion was necessary (early in the series). Exploration of the common bile duct was done via intraoperative cholangiography. There were no mortalities. The morbidity rate was 17%; (however, of the five patients concerned, four suffered from hyperthermia for 2 days. All of the children were improved and enjoyed resolution of their abdominal pain.. We believe that elective laparoscopic cholecystectomy at the earliest time possible, along with correct perioperative management, is the treatment of choice for cholelithiasis in children with sickle cell disease.

Topics: Abdominal Pain; Acetaminophen; Acute Disease; Anemia, Sickle Cell; Child; Child, Preschool; Cholecystectomy, Laparoscopic; Cholecystitis; Cholelithiasis; Female; Humans; Male; Nalbuphine; Pain, Postoperative

Topics: Adult; Analgesics, Opioid; Anesthetics, Local; Bupivacaine; Cesarean Section; Female; Humans; Injections, Spinal; Nalbuphine; Pain, Postoperative; Pregnancy; Risk Assessment

Topics: Analgesia, Epidural; Butorphanol; Humans; Nalbuphine; Narcotic Antagonists; Narcotics; Pain, Postoperative

The aim of this prospective study was to assess peroperative and postoperative analgesia in eye enucleation or evisceration performed under peribulbar anesthesia.. We report 31 patients undergoing an eye enucleation (17 cases) or evisceration (14 cases). The surgical procedure was performed under local anesthesia alone in 22 patients. General anesthesia was associated with local anesthesia in 9 patients. Peribulbar block was achieved with the first insertion of the needle parallel to the inferior orbital floor and the second at level of supraorbital notch. A mixed anesthetic solution of equal quantity of lidocaine 2% with epinephrine (0.25 mg/20 ml) and bupivacaine 0.50% with epinephrine (0.10 mg/20 ml) was injected (total quantity 16.8 +/- 4.3 ml).. To assess the peroperative pain we considered the patients with local anesthesia only (22 patients). One of these 22 patients needed one injection (0.50 mg/kg) of propofol for cutting the optic nerve. Surgery was ended without any other drug but that case was considered as a failure. Peroperative analgesia was obtained in 21 of 22 patients (95.4%). To assess analgesia in the postoperative period we included 31 patients. Analgesia was complete from the accomplishment of the peribulbar block to the 4th hour in all patients (efficacy 100%). From the 4th to the 24th hour, pain remained absent in 11 (enucleation 10 cases and evisceration 1 case) of the 31 patients and no drug was used. In 20 patients (enucleation 7 cases and evisceration 13 cases), pain appeared between the 4th and the 10th hour and patients were relieved by paracetamol alone in 14 cases (enucleation 6 cases and evisceration 8 cases) or by its association with nalbuphine in 5 cases (enucleation 1 case and evisceration 4 cases). In one patient (evisceration) the association of the drugs was uneffective.. Peribulbar anesthesia is safe and generates major postoperative analgesia so we suggest to offer that technique to patients undergoing evisceration or enucleation.

Topics: Acetaminophen; Adult; Aged; Aged, 80 and over; Analgesia; Analgesics, Non-Narcotic; Analgesics, Opioid; Anesthesia, General; Anesthesia, Local; Anesthetics, Local; Bupivacaine; Drug Combinations; Epinephrine; Eye Enucleation; Eye Evisceration; Female; Humans; Lidocaine; Male; Middle Aged; Nalbuphine; Pain, Postoperative; Sympathomimetics

To take advantage of the laparoscopic procedure, a new minimally invasive technique of appendectomy for nonobese and uncomplicated appendicitis is presented. Initially, diagnostic laparoscopy is performed through a minimal skin incision (microceliotomy) 1.5-2.0 cm in length in the right lower abdomen to rule out other disease. Then an appendectomy is performed using conventional surgical instruments under direct vision through the previous skin incision. There were 18 women and 12 men in this series. The mean age was 22.6 years. Pathologic findings of the appendix were: 2 normal, 13 catarrhal, 10 suppurative, and 5 gangrenous type. The mean operation time was 30.7 min. The mean frequency of postoperative analgesic requirement (nalbuphine 0.2 mg/kg) was 0.9 times. The mean hospital stay was 4.1 days (range, 2-7 days), and the duration until return to full activity was 7.6 days (range, 5-14 days). There was no mortality or morbidity. This appendectomy technique is a useful method for minimizing the postoperative pain and operative scar, thus allowing the patient an early return to full activity.

Topics: Activities of Daily Living; Adolescent; Adult; Analgesics, Opioid; Appendectomy; Appendicitis; Child; Cicatrix; Female; Gangrene; Humans; Laparoscopes; Laparoscopy; Length of Stay; Male; Microsurgery; Middle Aged; Minimally Invasive Surgical Procedures; Nalbuphine; Pain, Postoperative; Postoperative Complications; Suppuration; Time Factors

To assess the intensity of postoperative pain after laryngeal surgery for cancer and the efficacy of analgesic injections at fixed hours.. A prospective clinical study performed during the 3 days following laryngeal cancer surgery.. A university medical center.. Fifteen men (age range, 38-74 years) having just undergone a partial or total laryngectomy for epidermoid carcinoma.. The analgesic treatment consisted of intravenous administrations at fixed hours (propacetamol or nalbuphine hydrochloride), with the possibility of rescue doses on demand. Pain and anxiety were assessed by means of visual analog scales (graduated from 0-10) every 3 hours on postoperative day 1, then every 6 hours on postoperative days 2 and 3. Objective criteria, ie, heart and respiratory rates and mean blood pressure, were measured with the same schedule.. Postoperative pain and anxiety intensities and their variations were analyzed. Correlations between postoperative pain and other criteria were researched.. Postoperative pain had a high initial level (maximum median, 7), then decreased and reached a score of 3 at the 30th hour. Unpredictable individual peaks of pain were reported. Anxiety was never high (maximum median, 4). No individual correlation was found between pain and objective parameters.. After laryngeal surgery for cancer, pain can reach high levels, particularly in the first hours following recovery. Analgesic administrations at fixed hours are not effective enough. Postoperative analgesic treatment should aim to prevent the high initial pain and be individually adapted.

Topics: Acetaminophen; Adult; Aged; Analgesics, Opioid; Anxiety; Blood Pressure; Carcinoma, Squamous Cell; Heart Rate; Humans; Laryngeal Neoplasms; Laryngectomy; Male; Middle Aged; Nalbuphine; Pain Measurement; Pain, Postoperative; Prospective Studies; Respiration

Topics: Analgesics, Opioid; Antipruritics; Humans; Nalbuphine; Pain, Postoperative; Piperidines; Pruritus; Remifentanil

Postoperative pain management after scoliosis surgery is based in our institution on intrathecal morphine administration. This case report describes an immediate and major postoperative respiratory depression that occurred in the recovery room, requiring the maintenance of the endotracheal tube. This respiratory depression was reversed by i.v. administration of a low dose of nalbuphine, which allowed tracheal extubation without suppression of morphine-induced analgesia.

Topics: Adolescent; Anesthesia Recovery Period; Anesthesia, Spinal; Humans; Male; Morphine; Nalbuphine; Narcotic Antagonists; Pain, Postoperative; Respiratory Insufficiency; Scoliosis

Topics: Anesthesia; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Fentanyl; Humans; Nalbuphine; Narcotics; Pain, Postoperative

This is a retrospective study covering the ten-year period 1984-1993. Single shot spinal morphine (ITM) is compared with PCA nalbuphine for postoperative pain relief in children having abdominal or thoracic procedures. The records of 52 patients meeting selection criteria were examined. Nursing and physician notations were reviewed for hourly pain assessments, evidence of associated complications, respiratory depression, nausea and or vomiting, pruritus, and urinary retention. ITM provided significantly better pain relief (2.2 h in pain) during the first 24 h postoperatively than PCA nalbuphine (9.2 h in pain). With the exception of urinary retention which was significantly more frequent following ITM (58.6%) compared to PCA nalbuphine (8.7%), narcotic related complications were not different between the two groups. No difference in duration of hospital stay or ICU stay could be demonstrated. We conclude that ITM provides better pain relief, without more serious complications, than PCA nalbuphine. We recommend it as a safe, effective technique to treat postoperative pain in children following thoracic or upper abdominal procedures.

Topics: Abdomen; Adolescent; Analgesia, Patient-Controlled; Analgesics, Opioid; Child; Child, Preschool; Critical Care; Female; Hospitalization; Humans; Injections, Spinal; Length of Stay; Male; Morphine; Nalbuphine; Nausea; Pain Measurement; Pain, Postoperative; Pruritus; Respiration; Retrospective Studies; Thoracic Surgery; Urinary Retention; Vomiting

Surgery of the anterior cruciate ligament causes severe postoperative pain. This study aimed to compare efficacy and side effects of two postoperative analgesia methods, during 24 hours. Twenty healthy patients were assigned to two groups (n = 10): the patients of the first group were given by an epidural catheter 3 mg of morphine hydrochloride, every twelve hours. The patients of the second group received 2 mg h-1 of intravenous nalbuphine. The degree of pain was studied with a visual analogue scale. After the third postoperative hour, it was significantly higher in the second group, but the nalbuphine dose was low. The incidence of respiratory depression, nausea, pruritus was not statistically different between the groups, but 7/10 patients in the first group suffered of urinary retention (the first micturition was obtained 10.5 hours after the end of surgery in the first group and 5.3 h in the second one). Two patients needed an uretral catheter. These results might tend to show a greater efficactly of epidural morphine, with a higher incidence of urinary side effects.

Topics: Analgesia, Epidural; Analgesics, Opioid; Humans; Injections, Intravenous; Knee Joint; Ligaments, Articular; Male; Morphine; Nalbuphine; Pain, Postoperative; Respiration

The therapeutical efficiency and the undesirable effects of Nalbuphine administered to control postoperative pain were compared. Two groups of patients were studied: one group received 10 mg endovenously every 4 h during the first 12 h of the postoperative phase and every 6 h during the following 12 h while the other group received 20 mg with the same intervals. The following variants were evaluated: pain, systolic arterial tension, cardiac frequency, respiratory frequency and undesirable effects. After statistical analysis, a similarity in both groups was confirmed for pain, systolic arterial tension, cardiac frequency, while a significant difference was found in two of the undesirable effects: sedation and sweating. In conclusion, the 10 mg dose is as effective as that of 20 mg to control pain and has less unwanted effects.

Topics: Adult; Aged; Aged, 80 and over; Female; Hemodynamics; Humans; Male; Middle Aged; Nalbuphine; Pain, Postoperative; Prospective Studies

Nalbuphine-midazolam ataractanalgesia has been studied in anaesthesia and postoperative analgesia. Attention has been applied to the efficiency, pharmacological activity, side effects, adverse reactions of nalbuphine as a fentanyl substitute. Preliminary results show that nalbuphine could be used safely as anaesthesia component and as postoperative analgetic.

Topics: Adult; Anesthesia; Anesthesia Recovery Period; Conscious Sedation; Drug Evaluation; Fentanyl; Humans; Midazolam; Middle Aged; Nalbuphine; Pain, Postoperative; Pancuronium

A new opioid analgetic (Nalbufin hydrochloride) was applied to 28 patients having undergone abdominal operations. The time of application of the analgetic agent was determined by the patient himself, in accordance with the five-grade classification of pain, offered by Beaver and Feise. It is pointed out that nalbufin hydrochloride has adequate analgetic power and duration of analgetic activity which makes it suitable for postoperative analgesia.

Topics: Adult; Drug Evaluation; Female; Humans; Injections, Intramuscular; Male; Middle Aged; Nalbuphine; Pain Measurement; Pain, Postoperative; Postoperative Care; Preanesthetic Medication; Time Factors

The effect of nalbufin hydrochloride (Nubain) on breathing was studied in 28 patients after abdominal operations. It was shown that, regardless of its partial effect on the mu-receptors, Nubain caused no respiratory disturbances. The authors recommend it for analgesia in abdominal operations, but only after careful evaluation of the general status and the respiratory function in the operated patient.

Topics: Abdomen; Adult; Female; Hemodynamics; Humans; Injections, Intramuscular; Male; Middle Aged; Nalbuphine; Pain, Postoperative; Postoperative Care; Respiration; Surgical Procedures, Operative; Time Factors

Pain following thoracotomy reduces pulmonary ventilation in man and a similar effect is believed to occur in animals. The effects of two analgesic regimens on arterial blood gas parameters were studied in dogs following thoracotomy. Post-Operative analgesia was provided with intermittent nalbuphine, either alone or in combination with an intercostal nerve block using bupivacaine. Arterial blood gas analysis was carried out at 4, 8 and 16 h post-operatively, both before the administration of nalbuphine and again 30 min later. Animals which received nalbuphine alone had a significant rise in arterial oxygenation following administration of this analgesic. This effect was not observed at 4 and 8 h post-operatively in dogs which had an intercostal block with bupivacaine, but was seen at 16 h post-operatively when it could be anticipated that the effects of bupivacaine would have waned. These results suggest that intercostal block with bupivacaine can provide analgesia for over 8 h, and that the duration of action of nalbuphine in controlling post-operative pain in the dog is probably less than 4 h.

Topics: Animals; Blood Gas Analysis; Bupivacaine; Dogs; Intercostal Nerves; Nalbuphine; Nerve Block; Pain, Postoperative; Respiration; Thoracotomy

Nalbuphine hydrochloride, an agonist-antagonist opioid, is reported to reverse the respiratory depression of moderate doses of fentanyl (20 micrograms.kg-1) and still provide good analgesia. We report four patients having abdominal aortic aneurysm repair in which we attempted to reverse the respiratory depression of large doses of fentanyl (50-75 micrograms.kg-1) with nalbuphine (0.3 mg.kg-1, 0.1 mg.kg-1 or 0.05 mg.kg-1). Nalbuphine reversed respiratory depression in all four patients and the respiratory rate increased from 10 to 23 breaths per minute, end-tidal CO2 decreased from 7.0 +/- 0.3 per cent to 5.6 +/- 0.7 per cent, and peak inspiratory pressure after 0.1 seconds increased from 4 +/- 1.4 to 13 +/- 2.6 mmHg. However, hypertension, increased heart rate, and significant increase in analogue pain scores accompanied reversal of respiratory depression. Agitation, nausea, vomiting, and cardiac dysrhythmias also were observed frequently. We do not recommend the use of nalbuphine to facilitate early extubation of the trachea after large doses of fentanyl for abdominal aortic surgery.

Topics: Analgesia; Anesthesia, Intravenous; Aorta, Abdominal; Aortic Aneurysm; Blood Pressure; Cardiac Output; Fentanyl; Heart Rate; Humans; Male; Nalbuphine; Pain, Postoperative; Respiration

The analgesic nalbuphine was tested in Czechoslovakia in three departments of anaesthesiology. On 94 patients during the first 24 postoperative hours 43.3% of the patients were sufficiently treated with one injection of 10 mg nalbuphine, 30% needed two injections, 20% three injections and 6.7% four injections. The average duration of the analgesic effect was about 4 hours. Repeated injections achieved prolonged action. Side-effects occurred less frequently with nalbuphine than with morphine. It was shown that it is important in the postoperative period to start with the analgetic therapy before pain occurs.

Topics: Female; Humans; Male; Morphinans; Nalbuphine; Pain, Postoperative

Nalbuphine and nicomorphine were administered intramusculary in single doses for the relief of moderate to severe pain after abdominal surgery in a group of 40 patients to compare the analgesic effect and clinical tolerance during a 2 hour period. There was no statistically significant difference of the analgesic effect. In both groups SBP, DBP and RR decreased and HR increased significantly after injection but the tolerance of nalbuphine seems to be beter. Nalbuphine is a good choice for postoperative pain.

Topics: Adult; Aged; Blood Pressure; Female; Heart Rate; Humans; Injections, Intramuscular; Male; Middle Aged; Morphinans; Morphine Derivatives; Nalbuphine; Nicotinic Acids; Pain, Postoperative; Respiration

Topics: Adult; Aged; Double-Blind Method; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Injections, Spinal; Male; Middle Aged; Morphinans; Morphine; Nalbuphine; Pain, Postoperative

Topics: Child; Child, Preschool; Humans; Morphinans; Nalbuphine; Pain, Postoperative; Tonsillectomy

Endocrine and hemodynamic changes associated with the antagonism of fentanyl by nalbuphine have not been reported. Therefore, the authors studied ten patients after anesthetic induction with thiopental, fentanyl, tracheal intubation aided by succinylcholine and maintenance with diazepam, pancuronium, N2O, and further doses of fentanyl. Eight of the patients underwent cholecystectomy, one had a hysterectomy, and another had an abdominoplasty. After reversal of neuromuscular block at the conclusion of surgery, normal ventilation was restored by 0.22 +/- 0.02 mg/kg intravenous nalbuphine (mean +/- SEM). Plasma levels of free norepinephrine, histamine, and cortisol did not increase after antagonism of the fentanyl-induced respiratory depression, but plasma concentration of epinephrine increased significantly but without significant hemodynamic changes. Minute ventilation was 1.5 +/- 0.4 L/min before and 11 +/- 1, 10 +/- 1, 11 +/- 1, and 10 +/- 1 L/min at 15, 30, 45, and 60 min after antagonism; corresponding PaCO2 levels were 56 +/- 2, 44 +/- 1, 49 +/- 7, 49 +/- 1, 42 +/- 1 mm Hg. The mean analogue pain score remained below 1.5. We conclude that nalbuphine effectively antagonizes fentanyl-induced respiratory depression without adverse endocrine and circulatory changes or loss of analgesia.

Topics: Adult; Catecholamines; Drug Evaluation; Endocrine Glands; Female; Fentanyl; Hemodynamics; Histamine; Humans; Hydrocortisone; Morphinans; Nalbuphine; Pain Measurement; Pain, Postoperative; Respiration; Time Factors

A retrospective study was carried out to review the intra-operative use of nalbuphine at the average dose of 1.5 mg/kg as a supplement to isoflurane and enflurane in balanced anaesthesia in 108 surgical patients. Intra-operative cardiovascular stability and the quality of emergence were examined. The amount of halogenated anaesthetic used was compared to the theoretical amount that would have been needed in the absence of nalbuphine. In 90% to 95% of patients, blood pressures remained within 20% of baseline for the duration of anaesthesia. At emergence, 80% of patients had no pain. Nalbuphine appeared to reduce halogenated anaesthetic requirements by approximately 50%. These promising results for the intraoperative use of nalbuphine need to be confirmed by controlled prospective studies.

Topics: Adult; Aged; Anesthesia, General; Blood Pressure; Enflurane; Female; Humans; Isoflurane; Male; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Retrospective Studies

Six male patients were studied on the morning following upper abdominal surgery for highly selective vagotomy. Nalbuphine hydrochloride was infused i.v. at different rates that increased progressively in each hour over a 4-h period. In the last 15 min of each hour, the plasma nalbuphine concentrations were almost steady (73-68, 71-82, 116-113 and 201-208 ng ml-1). Patients and an observer made hourly assessments of pain and sedation. Although the changes in the pain and sedation scores were not significant, the patients' mean pain scores increased when the mean plasma nalbuphine concentrations were greater (greater than 82 ng ml-1), which suggested that nalbuphine analgesia had been reversed. Nalbuphine caused sedation and possibly induced amnesia which could invalidate retrospective assessment, since the patients' assessment of analgesic efficacy at the end of the study was good. No cardiovascular depression or significant decrease in the ventilatory rate was recorded.

Topics: Adult; Dose-Response Relationship, Drug; Humans; Male; Middle Aged; Morphinans; Nalbuphine; Pain Measurement; Pain, Postoperative; Patient Acceptance of Health Care; Vagotomy, Proximal Gastric

Topics: Abdomen; Aged; Butorphanol; Female; Humans; Injections, Epidural; Lung; Male; Middle Aged; Morphinans; Morphine; Nalbuphine; Pain, Postoperative

Twenty-five patients with moderate to severe pain after major upper abdominal surgery chose to receive nalbuphine on demand from a Cardiff Palliator for pain relief. An initial i.v. injection of nalbuphine 20 mg was followed by 5 mg given over 90s in response to each successful demand. A maximum of 20 doses (100 mg) hr-1 of nalbuphine was available, plus additional bolus doses. Twelve patients obtained good pain relief and completed the 5 hour observation period. 13 patients withdrew from the study, 8 because of inadequate pain relief and 2 because of side-effects. At least half the patients who complained of inadequate pain relief at the time had no subsequent memory of the events. Despite high dosage in some cases (up to 200 mg in an hour) no clinically important cardiovascular or respiratory effects were observed.

Topics: Adult; Aged; Female; Humans; Male; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Receptors, Opioid; Receptors, Opioid, kappa; Respiration

Nalbuphine (Nubain; Du Pont) 0.2 mg/kg (a new semisynthetic agonist-antagonist opioid) was compared with pethidine 0.75 mg/kg intravenously for analgesia after caesarean section in 70 patients. Statistical analysis of data showed that there was equivalence for analgesia, respiratory rate, cardiovascular parameters, side-effects and patient acceptance between the two drugs.

Topics: Adult; Cesarean Section; Female; Humans; Meperidine; Morphinans; Nalbuphine; Pain, Postoperative

The effect of nalbuphine on common bile duct (CBD) pressure was studied by measurements through T-tubes on the first and second postoperative days after cholecystectomy and choledochotomy. Nalbuphine in a dose of 0.25 mg X kg-1 was injected intramuscularly in 11 patients, and changes in biliary pressure, heart and respiratory rate, blood pressure, and arterial blood gases were recorded during the subsequent four hours. The patients were free of pain, had stable common bile duct pressures and did not have any statistically significant changes in their vital signs. These results are similar to our previous observations during perioperative intravenous injection of nalbuphine. It is suggested that nalbuphine does not significantly change, or even may relax, the sphincter of Oddi, and can therefore be recommended as a safe analgesic in the postoperative period after extrahepatic biliary surgery.

Topics: Adult; Aged; Biliary Tract Diseases; Cholecystectomy; Cholelithiasis; Common Bile Duct; Female; Humans; Male; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Pressure

Patient-controlled analgesia (PCA, intravenous self-application of narcotics) has been studied during the early postoperative period in 40 ASA I-III patients recovering from elective major and minor surgery (20 abdominal and 20 orthopaedic operations). Doses of 3.7 mg of the new agonist-antagonist opioid analgesic nalbuphine were available on demand, whenever the patients felt that pain relief was necessary, delivered by a microprocessor-controlled injection pump (On-Demand Analgesia Computer, ODAC) in response to use of a patient-controlled manual switch. The maximum dose/h was set at 28.2 mg, with a refractory time of 1 minute between successful demands. A continuous nalbuphine infusion (0.44 mg X h-1) was administered in addition in order to prevent obstruction of the catheter. The duration of the PCA period was 17.9 (0.4-28.0) h (median, range). During that time, 13.3 (1-45) demands per patient were recorded, resulting in median individual nalbuphine consumptions of 51.3 (8.1-1050.5) micrograms X kg-1 X h-1. Self-administration was characterized by considerable intra- and inter-individual variability. Following abdominal surgery significantly more nalbuphine was needed compared to orthopaedic patients, but it resulted in poorer pain relief. There were no statistically significant differences in drug requirements or pain scores between the sexes. Overall efficacy and patient acceptance proved to be good. When compared with previous conventional postoperative analgesia, the effectiveness of PCA was judged superior by about 57% of patients. Side effects (nausea, sweating) occurred in about 10% of patients but were usually of minor intensity. No serious circulatory or respiratory problems were observed during the period of PCA. Patient-controlled analgesia is a promising technique for the treatment of acute pain and for clinical pain research.

Topics: Adult; Female; Humans; Infusion Pumps; Male; Microcomputers; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Patient Participation; Self Administration

Topics: Aged; Anesthesia, General; Carbon Dioxide; Female; Fentanyl; Hemodynamics; Humans; Male; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Postoperative Period; Respiration; Respiration, Artificial; Time Factors

Topics: Adult; Aged; Clinical Trials as Topic; Ethics, Medical; Female; Humans; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative

Topics: Analgesics, Opioid; Humans; Morphinans; Nalbuphine; Pain, Postoperative; Self Administration

In 60 ASA class I or II patients given intravenous fentanyl for elective operations in doses large enough to produce postoperative respiratory depression, the intravenous administration of 20 mg nalbuphine resulted in prompt reversal of respiratory depression without loss of analgesia.

Topics: Adult; Blood Gas Analysis; Blood Pressure; Female; Fentanyl; Heart Rate; Humans; Male; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Postoperative Period; Respiration; Tidal Volume

In a double-blind study with the use of subjective reports of patients as indices of analgesia, we compared the analgesic effect of oral nalbuphine and acetaminophen and determined the contribution of each to the efficacy of their combination. In this parallel 2 X 2 factorial study, 129 inpatients after surgery were randomly assigned to treatment with a single oral dose of nalbuphine hydrochloride (30 mg), acetaminophen (650 mg), the combination of nalbuphine (30 mg) and acetaminophen (650 mg), or placebo. In the factorial analysis, both the nalbuphine and acetaminophen effects were significant for virtually every measure of total and peak analgesia, whereas the interaction contrast was not significant for any measure of analgesic effect. This indicates that the analgesic effect of the combination represents the additive effect of its constituents and is consistent with the results of studies of combinations of codeine and other opioids with aspirin or acetaminophen. There were few adverse effects other than sedation, which occurred twice as frequently in patients treated with nalbuphine as in those receiving acetaminophen or placebo. Our data suggest that this combination should prove at least as effective as any currently marketed narcotic-containing combination. Since nalbuphine has less dependence liability than narcotics and exhibits a ceiling on respiratory depression, its combination with acetaminophen should also be safer than comparable narcotic combinations.

Topics: Acetaminophen; Adult; Aged; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative; Random Allocation; Sleep Stages; Time Factors

Efficacy and safety of oral nalbuphine in doses of 15 and 45 mg were compared with those of the standard oral analgesic codeine in single doses of 30 and 90 mg in 153 patients with acute postoperative pain; data on 20 more patients were excluded because they received potentially interfering medications. All patients had pain ranging from moderate to severe in intensity and most had severe pain related to orthopedic procedures or trauma. Estimates of relative potency showed that nalbuphine was three times as potent as codeine. The most common side effect was sedation, which was greatest in patients who received the higher doses of codeine and nalbuphine. The effects of oral nalbuphine are much like those of oral codeine in patients with acute postoperative pain.

Topics: Adolescent; Adult; Aged; Analysis of Variance; Codeine; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Morphinans; Nalbuphine; Pain, Postoperative