hydrocodone and Pain--Postoperative

The United States is experiencing the highest opioid overdose death rate in our nation's history. Misuse and addiction to opioids, including prescription pain relievers, is a serious national crisis that affects public health as well as social and economic welfare.. The aim of the study was to critically evaluate postoperative opioid-prescribing patterns.. The PearlDiver database (Colorado Springs, CO) was queried for body contouring patients from 2010 to 2020. We identified patients that underwent panniculectomy, abdominoplasty, brachioplasty, thighplasty, mastopexy, breast augmentation, breast reduction, and liposuction for analysis. We subsequently analyzed the opioid use, with a focus on comorbid conditions and complications that are associated with increased use of opioids.. A total of 56,773 patients underwent body contouring surgery. The most common opioid prescribed was hydrocodone with acetaminophen (37,017 patients). Average days of therapy was 17.92 days. Comorbid conditions and postoperative complications were examined for risk of increased opioid prescriptions. Patients with peripheral vascular disease and smoking were prescribed significantly more morphine milliequivalents (MME) of opioids than patients without peripheral vascular disease (871.97 vs 535.41; P < .001) and smoking (1069.57 vs 440.84; P < .001). Patients who developed surgical site infection, disruption of wound, and venous thromboembolism were prescribed a significantly higher MME of opioids (1213.63 vs 561.59; P < .001).. Our data provide information on opioid prescription patterns in the body contouring population, with focused review of comorbid conditions and complications in relation to opioid-prescribing patterns. We hope that the data will improve opioid prescription habits among plastic surgeons in the setting of a global opioid crisis.

Topics: Analgesics, Opioid; Body Contouring; Humans; Hydrocodone; Opioid-Related Disorders; Pain, Postoperative; Practice Patterns, Physicians'; United States

Pain after tonsil surgery is troublesome because it causes discomfort. In addition, handling patients with postoperative pain is challenging to otolaryngologists. Many laboratory studies have assessed the use of analgesics and surgical techniques to discover methods for effective control of postoperative pain associated with tonsil surgery. In this review article, we summarize and provide a comprehensive overview of current methods for the control of pain after tonsil surgery based on findings of recent studies. Although powered intracapsular tonsillotomy is not popular yet, it seems to be an effective option among various surgical techniques. More discussion about powered intracapsular tonsillotomy should be done in the future. On the other hand, surgery with a harmonic scalpel, fibrin glue, or cryoanalgesia seems ineffective. When reviewing medical treatment methods, the use of nonsteroidal anti-inflammatory drugs, steroids, and/or gabapentin/pregabalin seems to be effective. However, the use of opioid (especially codeine) for children should be avoided because of possible respiratory insufficiency. Ketorolac is dangerous because of the risk of hemorrhage. We should continue to focus on the development of novel postoperative pain control techniques with no or low complications.

Topics: Adrenal Cortex Hormones; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cryotherapy; Electrocoagulation; Gabapentin; Humans; Hydrocodone; Laser Therapy; Pain, Postoperative; Pregabalin; Radiofrequency Ablation; Tonsillectomy; Tramadol; Ultrasonic Surgical Procedures

The Na. After establishing the selectivity of VX-548 for Na. A total of 303 participants were enrolled in the abdominoplasty trial and 274 in the bunionectomy trial. The least-squares mean difference between the high-dose VX-548 and placebo groups in the time-weighted SPID48 was 37.8 (95% confidence interval [CI], 9.2 to 66.4) after abdominoplasty and 36.8 (95% CI, 4.6 to 69.0) after bunionectomy. In both trials, participants who received lower doses of VX-548 had results similar to those with placebo. Headache and constipation were common adverse events with VX-548.. As compared with placebo, VX-548 at the highest dose, but not at lower doses, reduced acute pain over a period of 48 hours after abdominoplasty or bunionectomy. VX-548 was associated with adverse events that were mild to moderate in severity. (Funded by Vertex Pharmaceuticals; VX21-548-101 and VX21-548-102 ClinicalTrials.gov numbers, NCT04977336 and NCT05034952.).

Topics: Acetaminophen; Acute Pain; Analgesics; Analgesics, Opioid; Double-Blind Method; Humans; Hydrocodone; Pain, Postoperative

Topics: Acetaminophen; Analgesia; Analgesics, Non-Narcotic; Drug Combinations; Humans; Hydrocodone; Ibuprofen; Pain, Postoperative

Opioid/acetaminophen combinations may be overly prescribed in many post-surgical situations where a non-steroidal anti-inflammatory drug with equal or greater efficacy, fewer central nervous system side effects, and no risk for opioid abuse could be substituted. We compared a single, non-prescription dose of naproxen sodium 440 mg (NapS) against hydrocodone plus acetaminophen 10/650 mg (HYD+APAP) in post-impaction surgery pain.. Single-center, randomized, double-blind, placebo-controlled study in moderate-severe pain after surgical removal of impacted third molars (ClinicalTrials.gov: NCT04307940). Patients (n = 212) received NapS, HYD+APAP, or placebo and were assessed over 12 hours. Primary endpoint: summed pain intensity difference from 0 to 12 hours (SPID. All 221 randomized patients formed the safety population and were included in the intention-to-treat sensitivity analysis. Nine patients discontinued treatment or had protocol violations, and 212 patients were included in the per-protocol, primary efficacy population. Both active treatments were significantly more effective than placebo. NapS was significantly more effective than HYD+APAP regarding SPID. In moderate-to-severe postsurgical dental pain, a single dose of NapS was at least as effective as HYD+APAP in the early hours, significantly more effective at reducing pain intensity and providing greater pain relief over 12 hours, and was better tolerated. When not contraindicated, NapS should be considered a preferred alternative to opioid combinations for acute pain. (ClinicalTrials.gov, Identifier: NCT04307940; https://clinicaltrials.gov/ct2/show/NCT04307940).

Topics: Acetaminophen; Analgesics; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Drug Combinations; Humans; Hydrocodone; Naproxen; Pain, Postoperative; Tooth, Impacted

Endoscopic sinus surgery (ESS) and septoplasty are commonly performed procedures without standardized postoperative pain regimens. There is reluctance to prescribe opioids for postoperative pain given their potential for abuse. Nonsteroidal anti-inflammatory drugs (NSAIDs) have been demonstrated to reduce or even obviate the need for opioid pain medications after otolaryngologic surgeries, but prospective validation is lacking.. A randomized, controlled study comparing the efficacy of diclofenac sodium to hydrocodone/acetaminophen (APAP) after ESS with or without septoplasty was performed. Participants were given a 100-mm visual analog pain scale (VAS) at postoperative days (PODs) 1, 2, 3, and 5 after ESS. Two-sample t tests were used to compare pain scores between groups.. One hundred patients enrolled, and 74 patients provided pain scores to the survey. Pain was greatest for both groups on POD 1. Treatment with diclofenac sodium vs hydrocodone/APAP did not statistically impact pain scores at PODs 1, 2, 3, or 5. No cases of epistaxis requiring an emergency room visit or return to the operating room were noted during the study period.. Diclofenac sodium may be non-inferior to hydrocodone/APAP in treating pain after ESS with or without septoplasty in opioid naive patients without pre-existing pain conditions. Further studies with larger samples are warranted to investigate the potential superiority of diclofenac to hydrocodone/APAP in certain patients after ESS and septoplasty.

Topics: Acetaminophen; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Humans; Hydrocodone; Pain, Postoperative

North American surgeons continue to routinely order narcotic medication for postoperative pain relief after carpal tunnel surgery. For some patients, this instigates persistent use. This double-blind, multicenter trial investigated whether over-the-counter medications were inferior to opioid pain control after carpal tunnel release.. Patients undergoing carpal tunnel release in five centers in Canada and the United States (n = 347) were randomly assigned to postoperative pain control with (opioid) hydrocodone/acetaminophen 5/325 mg versus over-the-counter ibuprofen/acetaminophen 600/325 mg. The two primary outcome measures were the Numeric Pain Rating Scale (0 to 10) and the six-item Patient-Reported Outcome Measurement Information System Pain Interference T-score. Secondary outcome measures were total medication used and overall satisfaction with pain medication management.. The authors found no significant differences between opioid and over-the-counter patients in the Numeric Pain Rating Scale scores, Pain Interference T-scores, number of doses of medication, or patient satisfaction. The highest Numeric Pain Rating Scale group difference was the night of surgery, when opiate patients had 0.9/10 more pain than over-the-counter patients. The highest group difference in Pain Interference T-scores (2.1) was on the day of surgery, when the opiate patients had more pain interference than the over-the-counter group. Patient nationality or sex did not generate significant pain score differences.. Pain management is not inferior for patients managed with over-the-counter acetaminophen/ibuprofen versus opioids. This study provides high-quality evidence that U.S. and Canadian surgeons should stop the routine prescription of narcotics after carpal tunnel surgery for patients who are not taking pain medicines daily before surgery.. Therapeutic, II.

Topics: Acetaminophen; Adult; Aged; Analgesics, Non-Narcotic; Analgesics, Opioid; Canada; Carpal Tunnel Syndrome; Double-Blind Method; Female; Humans; Hydrocodone; Ibuprofen; Male; Middle Aged; Pain Measurement; Pain, Postoperative; Practice Patterns, Physicians'; Prospective Studies; United States; Young Adult

To examine the effects of preoperative gabapentin administration on postoperative pain in pediatric patients undergoing tonsillectomy/adenoidectomy (T/A) in a single ambulatory surgery location within a pediatric healthcare organization.. This randomized, controlled pilot study enrolled patients age 3-18 years with American Society of Anesthesiologists (ASA) scores of I-II undergoing T/A.. Both gabapentin and placebo groups were given study medication preoperatively and received standard opiate regimens intraoperatively and postoperative pain instructions. Outcome measurements included: time to first analgesic medication in the postanesthesia care unit (PACU), mean acetaminophen, ibuprofen, and opiate doses in mg/kg. Additionally, we examined pain scores, medication use, and side effects reported by daily pain diaries completed by patients/families for 3 days postoperatively.. Forty-nine patients were included in final analysis (gabapentin n = 26, placebo n = 23). Demographic and clinical characteristics of both groups were similar; the majority (46 of 49) were under the age of 13. Both groups received opiates in PACU. Some patients in both groups received hydrocodone/acetaminophen postoperatively. There were no reported differences in side effects between groups. Gabapentin group reported less use of opiates, acetaminophen, and ibuprofen post-discharge. We identified small effect sizes for opiates and acetaminophen, and medium effect size for ibuprofen (80.1% gabapentin versus 100% placebo, RR 0.81 [95% CI 0.67-0.97]). Median pain scores were 4 on a scale of 10 for both groups for all 3 days of follow-up. Overall median satisfaction score was 9, with a mean difference of 0.35 (95% CI -0.78 - 1.37). Analysis of variance revealed no difference in pain scores or satisfaction per pain diaries between the groups in general and no difference in score trajectory.. We were able to establish a rigorous process and feasibility to launch a larger, multi-center trial to examine this important issue. There remain few evidence-based options for acute pain relief in pediatric surgical populations besides opiates

Topics: Acetaminophen; Adenoidectomy; Adolescent; Aftercare; Analgesics; Analgesics, Opioid; Child; Child, Preschool; Double-Blind Method; Gabapentin; Humans; Hydrocodone; Ibuprofen; Pain Measurement; Pain, Postoperative; Patient Discharge; Pilot Projects; Premedication; Tonsillectomy

Opioid prescribing for postoperative pain management is challenging because of inter-patient variability in opioid response and concern about opioid addiction. Tramadol, hydrocodone, and codeine depend on the cytochrome P450 2D6 (CYP2D6) enzyme for formation of highly potent metabolites. Individuals with reduced or absent CYP2D6 activity (i.e., intermediate metabolizers [IMs] or poor metabolizers [PMs], respectively) have lower concentrations of potent opioid metabolites and potentially inadequate pain control. The primary objective of this prospective, multicenter, randomized pragmatic trial is to determine the effect of postoperative CYP2D6-guided opioid prescribing on pain control and opioid usage. Up to 2020 participants, age ≥8 years, scheduled to undergo a surgical procedure will be enrolled and randomized to immediate pharmacogenetic testing with clinical decision support (CDS) for CYP2D6 phenotype-guided postoperative pain management (intervention arm) or delayed testing without CDS (control arm). CDS is provided through medical record alerts and/or a pharmacist consult note. For IMs and PM in the intervention arm, CDS includes recommendations to avoid hydrocodone, tramadol, and codeine. Patient-reported pain-related outcomes are collected 10 days and 1, 3, and 6 months after surgery. The primary outcome, a composite of pain intensity and opioid usage at 10 days postsurgery, will be compared in the subgroup of IMs and PMs in the intervention (n = 152) versus the control (n = 152) arm. Secondary end points include prescription pain medication misuse scores and opioid persistence at 6 months. This trial will provide data on the clinical utility of CYP2D6 phenotype-guided opioid selection for improving postoperative pain control and reducing opioid-related risks.

Topics: Acute Pain; Analgesics, Opioid; Codeine; Cytochrome P-450 CYP2D6; Humans; Hydrocodone; Pain, Postoperative; Practice Patterns, Physicians'; Prospective Studies; Tramadol

To compare the efficacy of opioid versus nonopioid analgesic regimens after elective, soft tissue hand surgery. We hypothesized that there would be no difference in patient-perceived pain relief between these 2 groups.. This prospective, randomized, double-blinded controlled trial included patients undergoing elective soft tissue hand procedures (carpal tunnel release, trigger finger release, first dorsal compartment release, or ganglion cyst excision). Patients were randomized before surgery into 2 treatment groups: acetaminophen/hydrocodone 325/5 mg (AH, opioid group) or acetaminophen/ibuprofen 500/400 mg (AIBU, nonopioid group) and followed for 2 weeks after surgery evaluating daily pain intensity scores-visual analog scale (VAS), medication pain relief (Likert pain relief score), need for rescue opioid prescription at 1 week, and days until pain-free.. Sixty patients were randomized, 30 in the AH group and 30 in the AIBU group. There was no difference in the average VAS score. There was improved pain relief in the AIBU group, but the difference did not reach significance. There was no difference in time until pain-free, with a median of 5 days in the AH group and 3 days in the AIBU group. Two patients in each group required rescue opioid medication. Side effects were significantly more common in the AH group (n = 7; 23%) than the AIBU group (n = 1; 3%), but none were severe.. We recommend surgeons consider a combination of acetaminophen and ibuprofen as a safe and effective postoperative pain regimen for soft tissue hand surgery procedures.. Therapeutic I.

Topics: Acetaminophen; Adolescent; Adult; Aged; Aged, 80 and over; Analgesics, Non-Narcotic; Analgesics, Opioid; Carpal Tunnel Syndrome; Double-Blind Method; Drug Therapy, Combination; Female; Ganglion Cysts; Humans; Hydrocodone; Ibuprofen; Male; Middle Aged; Pain, Postoperative; Prospective Studies; Trigger Finger Disorder; Visual Analog Scale; Wrist Joint; Young Adult

To evaluate the prevention of opioid-induced nausea and vomiting (OINV) and the relief of moderate to severe acute pain by CL-108, a novel drug combining a low-dose antiemetic (rapid-release promethazine 12.5 mg) with hydrocodone 7.5 mg/acetaminophen 325 mg (HC/APAP) was used.. This was a multicenter, randomized, double-blind, placebo- and active-controlled multidose study. After surgical extraction of two or more impacted third molar teeth (including at least one mandibular impaction), 466 patients with moderate to severe pain (measured on a categorical pain intensity scale [PI-CAT]) were randomized to CL-108, HC/APAP, or placebo. Over the next 24 hours, patients used the PI-CAT to assess pain at regular intervals whereas nausea, vomiting, and other opioid-related side effects were also assessed prospectively. Study medications were taken every four to six hours as needed; supplemental rescue analgesic and antiemetic medications were permitted. Co-primary end points were the incidence of OINV and the time-weighted sum of pain intensity differences over 24 hours (SPID24).. Relative to HC/APAP treatment alone, CL-108 treatment reduced OINV by 64% (P < 0.001). Treatment with CL-108 significantly reduced pain intensity compared with placebo (SPID24 = 16.2 vs 3.5, P < 0.001). There were no unexpected or serious adverse events.. CL-108 is a safe and effective combination analgesic/antiemetic for the prevention of OINV during treatment of moderate to severe acute pain.

Topics: Acetaminophen; Acute Pain; Adolescent; Adult; Analgesics, Opioid; Antiemetics; Drug Combinations; Female; Humans; Hydrocodone; Male; Molar, Third; Nausea; Pain Measurement; Pain, Postoperative; Promethazine; Tooth Extraction; Tooth, Impacted; Treatment Outcome; Vomiting; Young Adult

To compare the efficacy of pain control and opioid consumption between patients who receive opioid as primary analgesic therapy and those who receive ibuprofen.. Prospective randomized trial.. Tertiary care academic hospital.. Adult patients undergoing outpatient otolaryngology surgery were assigned to take hydrocodone/acetaminophen or ibuprofen for postoperative analgesia. Patient-recorded pain scores and analgesic consumption were analyzed.. Out of 185 recruits, 108 (58%) completed responses. Fifty-six patients (52%) received opioid medication for primary analgesic treatment versus 52 (48%) who received ibuprofen. There was no difference in reported pain scores between the treatment groups. Those who received ibuprofen as primary therapy reported a significantly lower consumption of opioid medication at 2.04 tablets/pills (95% CI, 0.9-3.1) versus 4.86 (3.6-6.1; P = .001). Based on multivariate analysis, male sex and older age exhibited lower reported pain scores, while older age and use of ibuprofen as primary therapy exhibited lower opioid requirements.. For postoperative pain management in outpatient otolaryngology procedures, ibuprofen as primary therapy can provide equally effective pain control as compared with hydrocodone/acetaminophen while decreasing overall opioid requirement. Prescription pill counts are further described to help guide physician practices in the era of an opioid epidemic.

Topics: Acetaminophen; Adolescent; Adult; Aged; Aged, 80 and over; Ambulatory Surgical Procedures; Analgesics, Opioid; Drug Combinations; Female; Humans; Hydrocodone; Ibuprofen; Male; Middle Aged; Otorhinolaryngologic Surgical Procedures; Pain Measurement; Pain, Postoperative; Prospective Studies; Single-Blind Method; Young Adult

To determine the efficacy of oral extended-release hydrocodone compared with oral firocoxib for analgesia following tibial plateau leveling osteotomy surgery in dogs in a hospital setting.. Prospective, randomized, blinded, clinical trial.. Thirty-six client-owned dogs weighing 25-43 kg with unilateral hindlimb lameness and cranial cruciate ligament rupture.. Dogs were assigned to 1 of 2 groups (n = 18/group). Group 1 received hydrocodone 3 mg/kg orally every 24 hours, and group 2 received firocoxib 5 mg/kg orally every 24 hours. Both hydrocodone and firocoxib (according to group assignment) were provided as preemptive analgesia 10 hours before induction to anesthesia and then every 24 hours for the remainder of the study period The level of analgesia was compared between treatments on the basis of a modified Glasgow Composite Pain Score (mGCPS) in each dog, the number of dogs requiring rescue analgesia (hydromorphone 0.05 mg/kg subcutaneously), pressure platform stance data, and number of adverse events.. Nine of 18 dogs that received hydrocodone and 2/18 dogs that received firocoxib had an mGCPS ≥6 (P = .02). Two dogs had an mGCPS ≥6 three times, and 1 had an mGCPS ≥6 two times; all 3 of these dogs were in the hydrocodone group. Average postoperative peak pressure placed on the affected limb was lower in dogs that received hydrocodone (P = .01). Regurgitation and decreased appetite were more common in the dogs that received hydrocodone.. Dogs that were treated with hydrocodone exhibited higher pain scores and lower limb function than dogs treated with firocoxib under the conditions of our study.. Our results do not provide evidence to justify the administration of extended-release hydrocodone at 3 mg/kg orally every 24 hours rather than firocoxib at 5 mg/kg orally every 24 hours in dogs undergoing tibial plateau leveling osteotomy.

Topics: 4-Butyrolactone; Analgesia; Animals; Anterior Cruciate Ligament Injuries; Delayed-Action Preparations; Dogs; Female; Hydrocodone; Male; Osteotomy; Pain Management; Pain, Postoperative; Prospective Studies; Sulfones; Tibia

Celecoxib is a cyclooxygenase-2-specific inhibitor indicated to treat acute pain and pain secondary to osteoarthritis and rheumatoid arthritis. Surgical models of acute pain have demonstrated superior pain relief to placebo. The objective of this study was to test the safety and efficacy of celecoxib for pain relief after tonsillectomy compared to placebo.. Adult subjects were randomized to 200 mg celecoxib versus placebo with a loading dose the night before surgery then twice daily for 10 days. Subjects were instructed to supplement the study drug with hydrocodone/acetaminophen liquid or acetaminophen for pain as needed. Subjects completed a daily diary regarding their pain, nausea, vomiting, diet, and activity.. Seventeen subjects enrolled. Intraoperative blood loss was similar between groups, and no subject had postoperative bleeding. Three patients returned to the emergency department for treatment, and 2 patients could not complete the diaries, all in the placebo group. Subjects in the placebo group required statistically significant (P < .05) higher doses of narcotic and acetaminophen to control pain. Pain and diet rating scores were slightly better in the celecoxib group compared to placebo.. In this small cohort, celecoxib reduced postoperative narcotic and acetaminophen requirements compared to placebo without complications.

Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Celecoxib; Chronic Disease; Cyclooxygenase 2 Inhibitors; Double-Blind Method; Drug Combinations; Female; Humans; Hydrocodone; Male; Pain Management; Pain Measurement; Pain, Postoperative; Prospective Studies; Recurrence; Tonsillectomy; Tonsillitis; Young Adult

The purpose of this prospective, double-blind, randomized clinical trial was to evaluate the postoperative healing of endodontic periapical microsurgery after local administration of dexamethasone.. Sixty patients were divided into 2 groups. The dexamethasone group received a single local submucosal injection of 4 mg dexamethasone, and the placebo group received a submucosal injection of saline solution at the conclusion of standardized periapical microsurgery. Acetaminophen and hydrocodone/acetaminophen were prescribed for pain relief. A Likert-like 6-point scale was used for self-evaluation of pain, bruising, swelling, and wound healing at 24, 48, 72, 96 hours and at 1 week. The number of tablets taken was registered. Data were analyzed using the chi-square and Fisher exact tests at a significance level of P < .05.. No improvements in pain, bruising, and wound healing were registered at any time interval. No difference was found in the number of tablets taken for pain relief. Subjects who received the dexamethasone injection reported less swelling 24 hours after periapical microsurgery (P < .05) but showed no significant benefit for the longer follow-up periods.. This study shows that a 4-mg dose of dexamethasone administered through a local submucosal injection after periapical microsurgery has minimal impact on pain, bruising, and apparent wound healing at any time over a 7-day interval, and the impact on swelling seems limited.

Topics: Acetaminophen; Adrenal Cortex Hormones; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Anesthesia, Local; Anti-Inflammatory Agents; Apicoectomy; Contusions; Dexamethasone; Double-Blind Method; Drug Combinations; Edema; Female; Humans; Hydrocodone; Inflammation; Male; Microsurgery; Pain, Postoperative; Periapical Tissue; Prospective Studies; Wound Healing

Lortab® Elixir, a proprietary combination product containing hydrocodone and acetaminophen, is approved in the US for the treatment of moderate to moderately severe pain in children. Despite this approval, pediatric pharmacokinetic data using this product have not been previously published. Using a single-dose open-label study approach, we evaluated the pharmacokinetics, tolerability, and safety of this product in 17 healthy children 6-17 years of age. Results showed that the body weight-normalized oral clearance (L/h/kg) of hydrocodone and acetaminophen were 42% and 27% higher, respectively when compared to data from healthy adults. This suggests that a higher mg/kg dose would be required in children to achieve exposures similar to adults. We found adjustment of hydrocodone and acetaminophen dose by body surface area to be more optimal than body weight-based dose adjustments for achieving similar systemic exposure in children and adults. However, body weight-based hydrocodone and acetaminophen dosing regimens provided close approximation of adult exposures in pediatric patients with approximately 22% to 24% lower hydrocodone and acetaminophen dose/BW-normalized AUC in pediatric patients compared to adults. Finally, the adverse event profile in our pediatric cohort was consistent with that expected of opioid-naive subjects receiving opioid-combination therapy.

Topics: Acetaminophen; Adolescent; Analgesics, Opioid; Area Under Curve; Body Surface Area; Body Weight; Child; Dose-Response Relationship, Drug; Drug Combinations; Female; Humans; Hydrocodone; Male; Pain, Postoperative

A fixed-dose combination biphasic immediate-release (IR)/extended-release (ER) hydrocodone bitartrate (HB)/acetaminophen (APAP) tablet is being developed for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate.. This Phase III, randomized, double-blind, placebo-controlled, parallel-group study evaluated the analgesic efficacy and safety of IR/ER HB/APAP (n = 201) versus placebo (n = 202) over a period of 48 hours in patients with acute moderate to severe pain following unilateral bunionectomy. Patients received three tablets of placebo or IR/ER HB/APAP as an initial dose (hour 0) followed by two tablets every 12 hours for a total daily dose of 37.5/1625 mg HB/APAP on day 1 and 30/1300 mg HB/APAP thereafter. The primary efficacy outcome was the summed pain intensity difference (SPID) over the first 48 hours (SPID48) after the first dose.. SPID48 was significantly greater with IR/ER HB/APAP versus placebo (p < 0.001). SPID dosing interval analyses demonstrated consistent, superior pain relief with IR/ER HB/APAP for each dosing interval (all p < 0.001). Mean PID was greater with IR/ER HB/APAP versus placebo beginning 30 minutes after the first dose (p < 0.05), and IR/ER HB/APAP demonstrated faster median time to the onset of perceptible, meaningful, and confirmed pain relief (all p < 0.001). Mean total pain relief scores also indicated greater pain relief with IR/ER HB/APAP versus placebo throughout the 48-hour period (p = 0.012) for all comparisons. A greater proportion of IR/ER HB/APAP versus placebo patients was either "very satisfied" or "satisfied" with their pain relief (69.3% vs 49.4%; p < 0.001). Nausea was the most common treatment-emergent adverse event (TEAE; IR/ER HB/APAP, 25%; placebo, 7.9%). All TEAEs in IR/ER HB/APAP-treated patients were mild or moderate in severity.. IR/ER HB/APAP provided rapid, significant, and consistent analgesic efficacy over a period of 48 hours in an established model of acute pain and was tolerated with a safety profile similar to other low-dose opioids.

Topics: Acetaminophen; Acute Pain; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Delayed-Action Preparations; Double-Blind Method; Drug Combinations; Female; Humans; Hydrocodone; Male; Middle Aged; Nausea; Orthopedic Procedures; Pain Management; Pain Measurement; Pain, Postoperative; Tablets; Treatment Outcome

To evaluate the pharmacokinetics of hydrocodone (delivered in combination with acetaminophen) and tramadol in dogs undergoing tibial plateau leveling osteotomy (TPLO).. 50 client-owned dogs.. Dogs were randomly assigned to receive tramadol hydrochloride (5 to 7 mg/kg, PO, q 8 h; tramadol group) or hydrocodone bitartrate-acetaminophen (0.5 to 0.6 mg of hydrocodone/kg, PO, q 8 h; hydrocodone group) following TPLO with standard anesthetic and surgical protocols. Blood samples were collected for pharmacokinetic analysis of study drugs and their metabolites over an 8-hour period beginning after the second dose of the study medication.. The terminal half-life, maximum serum concentration, and time to maximum serum concentration for tramadol following naïve pooled modeling were 1.56 hours, 155.6 ng/mL, and 3.90 hours, respectively. Serum concentrations of the tramadol metabolite O-desmethyltramadol (M1) were low. For hydrocodone, maximum serum concentration determined by naïve pooled modeling was 7.90 ng/mL, and time to maximum serum concentration was 3.47 hours. The terminal half-life for hydrocodone was 15.85 hours, but was likely influenced by delayed drug absorption in some dogs and may not have been a robust estimate. Serum concentrations of hydromorphone were low.. The pharmacokinetics of tramadol and metabolites were similar to those in previous studies. Serum tramadol concentrations varied widely, and concentrations of the active M1 metabolite were low. Metabolism of hydrocodone to hydromorphone in dogs was poor. Further study is warranted to assess variables that affect metabolism and efficacy of these drugs in dogs.

Topics: Acetaminophen; Analgesics, Opioid; Animals; Area Under Curve; Dogs; Half-Life; Hydrocodone; Hydromorphone; Osteotomy; Pain, Postoperative; Tramadol

To evaluate clinical efficacy of hydrocodone-acetaminophen and tramadol for treatment of postoperative pain in dogs undergoing tibial plateau leveling osteotomy (TPLO). ANIMALS 50 client-owned dogs.. Standardized anesthetic and surgical protocols were followed. Each patient was randomly assigned to receive either tramadol hydrochloride (5 to 7 mg/kg, PO, q 8 h; tramadol group) or hydrocodone bitartrate-acetaminophen (0.5 to 0.6 mg of hydrocodone/kg, PO, q 8 h; hydrocodone group) for analgesia after surgery. The modified Glasgow composite measure pain scale was used to assess signs of postoperative pain at predetermined intervals by an investigator who was blinded to treatment group. Scoring commenced with the second dose of the assigned study analgesic. Pain scores and rates of treatment failure (ie, dogs requiring rescue analgesia according to a predetermined protocol) were compared statistically between groups.. 12 of 42 (29%; 5/19 in the hydrocodone-acetaminophen group and 7/23 in the tramadol group) dogs required rescue analgesic treatment on the basis of pain scores. Median pain score for the hydrocodone group was significantly lower than that of the tramadol group 2 hours after the second dose of study analgesic. The 2 groups had similar pain scores at all other time points.. Overall, differences in pain scores between dogs that received hydrocodone-acetaminophen or tramadol were minor. The percentage of dogs with treatment failure in both groups was considered unacceptable.

Topics: Acetaminophen; Analgesia; Analgesics; Analgesics, Opioid; Animals; Anti-Inflammatory Agents, Non-Steroidal; Dog Diseases; Dogs; Drug Combinations; Hydrocodone; Osteotomy; Pain Measurement; Pain, Postoperative; Tramadol; Treatment Outcome

DepoDur, an extended-release epidural morphine, has been used effectively for postoperative pain control following many orthopaedic and general surgery procedures and has provided prolonged analgesia when compared with Duramorph. The goal of this article was to compare the safety and analgesic efficacy of DepoDur versus Duramorph after lumbar spine surgery. A prospective, randomized, double-blind clinical study was completed at a single extended-stay ambulatory surgery center. All patients over 18 undergoing posterior lumbar spine fusions were considered for the study. Sixty patients were randomly assigned to a control or treatment group. The control group received DepoDur before surgery, while the treatment group received Duramorph. Although results show no significant differences between the two groups in postoperative visual analog pain scale scores, use of pain medication, and adverse events, subjects receiving DepoDur were less likely to receive Naloxone and oxygen supplementation, experience nausea or fever, and were more likely to experience hypotension. DepoDur proved to be safe and effective, offering similar prolonged analgesic activity when compared with Duramorph.

Topics: Analgesia, Epidural; Analgesics, Opioid; Double-Blind Method; Humans; Hydrocodone; Lumbar Vertebrae; Middle Aged; Morphine; Pain Measurement; Pain, Postoperative; Postoperative Complications; Prospective Studies; Spinal Fusion

This study investigates the importance of communication in surgery and how delivering preoperative patient education can lead to better health outcomes postoperatively, via promoting tolerable pain scores and minimizing the use of narcotics after surgery. Patients who underwent outpatient surgery were randomly divided into groups to compare the pain scores of those who received preoperative patient education, the experimental group, and those who did not receive any form of patient education, the control group. Two weeks before surgery, the experimental group subjects received oral and written forms of patient education consisting of how the body responds to pain, and how endorphins cause natural analgesia. Moreover, patients were educated on the negative effects narcotics have on endorphin production and activity, as well as mechanisms of non-opioid analgesics. Of the 69 patients in the experimental group, 90% declined a prescription for hydrocodone after receiving preoperative education two weeks prior to surgery. The control group consisted of 66 patients who did not receive preoperative patient education and 100% filled their hydrocodone prescriptions. Patients in both groups were offered and received gabapentin and celecoxib preoperatively for prophylaxis of postoperative pain unless they declined. The control groups were found to have average pain scores significantly greater (P <.05) than the experimental groups and also a significantly longer (P <.005) duration of pain. This study illustrates the power of patient education via oral, written and visual communication, which can serve as an effective means to minimize narcotic analgesia after surgery.

Topics: Acetaminophen; Adult; Amines; Analgesics; Analgesics, Opioid; Celecoxib; Communication; Cyclohexanecarboxylic Acids; Drug Prescriptions; Endorphins; Gabapentin; gamma-Aminobutyric Acid; Humans; Hydrocodone; Middle Aged; Pain Management; Pain Measurement; Pain, Postoperative; Patient Education as Topic; Patient Preference; Preoperative Care; Pyrazoles; Sulfonamides; Young Adult

The purpose of this study, in a sample of preschool children (ages 3-5 years; N = 47), was to evaluate the feasibility of scheduled analgesic dosing following outpatient tonsillectomy in order to optimize pain management.. Parents were instructed to give their child acetaminophen with hydrocodone (167 mg/5 mL) every 4 hours around the clock for the first 3 days following surgery. Parents recorded ratings of their child's pain with/without swallowing using the Faces, Legs, Activity, Cry, and Consolability (FLACC) behavioral pain scale, pain relief ratings, and severity of analgesic side effects in a home diary. Audiotaped interviews were conducted with parents to document descriptions of their experiences in managing their child's pain at home.. Mean FLACC scores with/without swallowing were less than two at each measurement time and pain relief scores increased over time. Total analgesic dose decreased, and the number of missed doses increased over the first 3 days after surgery. Moderate-to-severe daytime sedation, nausea, vomiting, and constipation were reported by parents.. Study results suggest that acetaminophen with hydrocodone is effective in relieving preschool children's pain following tonsillectomy and that parental adherence to a scheduled analgesic regimen decreases over time. Time-contingent dosing was associated with moderate to severe side effects and should be addressed in discharge teaching with parents. Findings provide insight into parents' perspective of pain management at home following tonsillectomy and methods for relieving their child's pain.

Topics: Acetaminophen; Administration, Oral; Analgesics, Opioid; Caregivers; Child, Preschool; Drug Combinations; Feasibility Studies; Home Care Services; Humans; Hydrocodone; Medication Adherence; Pain Management; Pain, Postoperative; Parents; Tonsillectomy

Although hydrocodone-acetaminophen is commonly used for pain control in first-trimester abortion, the efficacy of oral opioids for decreasing pain has not been established. Our objective was to estimate the effect of hydrocodone-acetaminophen on patient pain perception during first-trimester surgical abortion.. We conducted a randomized, double-blinded, placebo-controlled trial. Patients (before 11 weeks of gestation) received standard premedication (ibuprofen and lorazepam) and a paracervical block with the addition of 10 mg hydrocodone and 650 mg acetaminophen or placebo 45-90 minutes before surgical abortion. A sample size of 120 was calculated to provide 80% power to show a 15-mm difference (α=0.05) in the primary outcome of pain with uterine aspiration (100-mm visual analog scale). Secondary outcomes were pain at additional time points, satisfaction, side effects, adverse events, and need for additional pain medications.. There were no significant differences in demographics or baseline pain between groups. There were no differences in pain scores between patients receiving hydrocodone-acetaminophen compared with placebo during uterine aspiration (65.7 mm compared with 63.2 mm, P=.59) or other procedural time points. There were no differences in satisfaction or need for additional pain medications. Patients who received hydrocodone-acetaminophen had more postoperative nausea than those receiving placebo (P=.03) when controlling for baseline nausea. No medication-related adverse events were noted.. Hydrocodone-acetaminophen does not decrease pain during first-trimester abortion and may increase postoperative nausea.. Clinicaltrials.gov, www.clinicaltrials.gov, NCT01330459.. I.

Topics: Abortion, Induced; Acetaminophen; Adolescent; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Double-Blind Method; Drug Combinations; Female; Humans; Hydrocodone; Pain Management; Pain Perception; Pain, Postoperative; Pregnancy; Pregnancy Trimester, First; Young Adult

Previous studies have addressed post-operative pain management after ACL reconstruction by examining the use of intra-articular analgesia and/or modification of anesthesia techniques. To our knowledge, however, no previous studies have evaluated the effect of zolpidem on post-operative narcotic requirements, pain, and fatigue in patients undergoing outpatient arthroscopic ACL reconstruction. The purpose of this prospective, blinded, randomized, controlled clinical study was to evaluate the effect of zolpidem on post-operative narcotic requirements, pain, and fatigue in patients undergoing outpatient arthroscopic ACL reconstruction.. Twenty-nine patients undergoing arthroscopic ACL reconstruction were randomized to a treatment group or placebo group. Both groups received post-operative hydrocodone/acetaminophen bitartrate (Vicodin ES). Patients in the treatment group received a single dose of zolpidem for the first seven post-operative nights. Patients in the placebo group received a gelatin capsule similar in appearance to zolpidem. The amount of Vicodin used in each group, the amount of post-operative pain, and the amount of post-operative fatigue were analyzed.. Following ACL reconstruction, a 28% reduction was seen in the total amount of narcotic consumed with zolpidem (P = 0.047) when compared to placebo. There were no significant differences in post-operative pain or fatigue levels between zolpidem and placebo.. Adding zolpidem to the post-operative medication regimen after arthroscopic ACL reconstruction helps to lower the amount of narcotic pain medication required for adequate analgesia.. Randomized controlled clinical trial, Level I.

Topics: Acetaminophen; Adult; Analgesics, Opioid; Analysis of Variance; Anterior Cruciate Ligament; Anti-Inflammatory Agents, Non-Steroidal; Arthroscopy; Drug Combinations; Female; Humans; Hydrocodone; Hypnotics and Sedatives; Ibuprofen; Magnetic Resonance Imaging; Male; Pain Measurement; Pain, Postoperative; Placebos; Plastic Surgery Procedures; Prospective Studies; Pyridines; Surveys and Questionnaires; Treatment Outcome; Zolpidem

To determine the efficacy of preoperatively administered nicotine nasal spray (3 mg) for analgesia after third molar (TM) surgery.. A single-center, prospective, randomized, double-blind, crossover trial was conducted. The study population consisted of 20 nonsmoking patients referred to the Department of Oral and Maxillofacial Surgery of Columbia University College of Dental Medicine for extraction of all 4 TMs. Each patient received nicotine nasal spray or placebo spray before TM surgery. At a subsequent visit the contralateral TMs were removed with prior administration of the alternate treatment. For an hour postoperatively, subjects reported information on pain and nausea, and hemodynamic variables were recorded at 15-minute intervals. Telephone follow-up was recorded for 5 days postoperatively, where patients reported information on pain, nausea, and use of hydrocodone/acetaminophen as rescue analgesia.. Nicotine treatment was associated with a highly significant decrease in pain reported during the 5 days after TM surgery. There was no difference in the amount of hydrocodone/acetaminophen used or amount of nausea reported. There was a small but significant increase in heart rate after nicotine treatment compared with placebo during the first hour after surgery. There was no difference in blood pressure between groups.. Pain is well controlled by hydrocodone/acetaminophen in most patients after TM surgery. However, there is significant variability in pain reported. Nicotinic agonists represent a new class of analgesic that can be considered for patients who are expected to have significant opioid-resistant pain after TM surgery. Caution should be used with patients in whom a small increase in heart rate would be deleterious.

Topics: Acetaminophen; Administration, Intranasal; Adolescent; Adult; Analgesics; Analgesics, Non-Narcotic; Analgesics, Opioid; Blood Pressure; Cross-Over Studies; Double-Blind Method; Female; Follow-Up Studies; Ganglionic Stimulants; Heart Rate; Humans; Hydrocodone; Male; Middle Aged; Molar, Third; Nicotine; Pain, Postoperative; Placebos; Postoperative Nausea and Vomiting; Premedication; Prospective Studies; Treatment Outcome; Young Adult

The purpose of this prospective, randomized, double-blind study was to determine ibuprofen versus ibuprofen/acetaminophen use for postoperative endodontic pain in symptomatic patients with a pulpal diagnosis of necrosis and an associated periapical radiolucency who were experiencing moderate to severe preoperative pain. We also recorded escape medication use.. Seventy-one adult patients presenting for emergency endodontic treatment with a symptomatic maxillary or mandibular tooth with a pulpal diagnosis of necrosis, periapical radiolucent area, and moderate to severe pain participated in this study. The patients were randomly divided into 2 groups by random assignment and numeric coding. An emergency debridement of the tooth was completed with hand and rotary instrumentation. At the end of the appointment, the patients randomly received capsules of either 600 mg ibuprofen or 600 mg ibuprofen combined with 1000 mg acetaminophen (blinded to both operator and patient). Patients also received a 6-day diary to be completed after anesthesia wore off and every morning for 5 days. Patients were asked to record pain, symptoms, and the number of capsules taken. Patients received escape medication (Vicodin) if the study medication did not control their pain. Postoperative data were analyzed by randomization test and step-down Bonferroni method of Holm.. There were decreases in pain levels and analgesic use over time for the ibuprofen and ibuprofen/acetaminophen groups. There was no statistically significant difference between the 2 groups for analgesic use or escape medication use. Approximately 20% of patients in both groups required escape medication to control pain.

Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Calcium Sulfate; Dental Cements; Dental Pulp Necrosis; Double-Blind Method; Drug Combinations; Female; Follow-Up Studies; Humans; Hydrocodone; Ibuprofen; Male; Medical Records; Pain, Postoperative; Periapical Diseases; Polyvinyls; Prospective Studies; Root Canal Filling Materials; Root Canal Irrigants; Root Canal Preparation; Zinc Oxide

To determine the effectiveness of around-the-clock (ATC) analgesic administration, with or without nurse coaching, compared with standard care with as needed (PRN) dosing in children undergoing outpatient tonsillectomy.. Children 6 to 15 years of age were randomized to receive acetaminophen and hydrocodone (167 mg/2.5 mg/5 mL) for 3 days after surgery: Group A (N=39)-every 4 hours PRN, with standard postoperative instructions; Group B (N=34)-every 4 hours ATC, with standard postoperative instructions, without nurse coaching; and Group C (N=40)-every 4 hours ATC, with standard postoperative instructions, with coaching. Parents completed a medication log, and recorded the presence and severity of opioid-related adverse effects and children's reports of pain intensity using a 0 to 10 numeric rating scale.. No differences were found in analgesic administration or pain intensity scores between the 2 ATC groups. Therefore, they were combined for comparison with the PRN group. Children in the ATC group received more analgesic than those in the PRN group (P<0.0001). Children in the PRN group had higher pain intensity scores compared to children in the ATC group, both at rest (P=0.017) and with swallowing (P=0.017). Pain intensity scores for both groups were higher in the morning compared with the evening (P<0.0001). With the exception of constipation, scheduled analgesic dosing did not increase the frequency or severity of opioid-related adverse effects.. Scheduled dosing of acetaminophen and hydrocodone is more effective than PRN dosing in reducing pain intensity in children after tonsillectomy. Nurse coaching does not impact parent's adherence to ATC dosing.

Topics: Acetaminophen; Adolescent; Analgesics, Non-Narcotic; Analgesics, Opioid; Analysis of Variance; Child; Double-Blind Method; Dreams; Drug Administration Schedule; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Hydrocodone; Male; Nausea; Pain Measurement; Pain, Postoperative; Tonsillectomy; Treatment Outcome; Vomiting

Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC) is a rapidly absorbed formulation of diclofenac potassium developed for the treatment of mild to moderate acute pain.. The present study was conducted to assess the efficacy and safety profile of DPSGC 25 mg in patients with pain after first-metatarsal bunionectomy.. This was a Phase III, multicenter, randomized, double-blind, parallel-group, placebo-controlled study conducted over 5 days. Patients experiencing the requisite level of pain (score > or = 4 on an 11-point numeric pain rating scale [NPRS] from 0 = no pain to 10 = worst possible pain) on the day after bunionectomy were randomized to receive DPSGC 25 mg or matching placebo. A second dose was given when patients requested additional medication for pain. Subsequent doses were given every 6 hours over a 48-hour inpatient multiple-dose period and continued over an additional 48-hour outpatient multiple-dose period. Opioid rescue medication was available as needed after the second dose of study medication. The primary efficacy end point was the mean NPRS score over the 48-hour inpatient multiple-dose period. Additional measures included NPRS scores at predefined times over 48 hours, the summed pain intensity difference over 48 hours (SPID48), the time-weighted sum of pain relief scores over the first 8 hours, the mean dosing interval (the time from dosing to the time rescue medication or the next dose of study medication was administered, whichever was less), the proportion of patients requiring rescue medication, and the onset of perceptible and meaningful pain relief (2-stopwatch method). Tolerability was assessed based on physician monitoring and patient reporting of adverse events (AEs) and the results of standard laboratory tests.. Of 201 randomized patients (102 DPSGC 25 mg, 99 placebo; 86.6% female; 58.2% white; mean [SD] age, 45.2 [11.5] years; weight range, 49.4-108.0 kg), 198 completed the study. Mean baseline NPRS scores did not differ significantly between the DPSGC and placebo groups (6.9 and 7.3, respectively). DPSGC was associated with significant improvements compared with placebo in mean NPRS score over 48 hours (2.5 vs 5.6, respectively; P < 0.001), mean SPID48 (210.0 vs 90.3; P < 0.001), and overall mean dosing interval (331.5 vs 263.9 min; P < 0.001). Significant differences in NPRS scores between DPSGC 25 mg and placebo were noted at all time points from baseline through 48 hours (P < 0.001). The proportion of patients requiring rescue medication was significantly lower in the DPSGC group compared with the placebo group (39.2% vs 87.9% on day 1; 21.6% vs 64.6% on day 2; both, P < 0.001). Patients receiving DPSGC had a significantly faster onset of meaningful pain relief compared with those receiving placebo (P = 0.008). The most commonly reported AEs were nausea (7.8% vs 18.2%), headache (5.9% vs 9.1%), vomiting (3.9% vs 9.1%), and constipation (3.9% vs 2.0%). The overall incidence of AEs occurring in > or = 2% of patients was significantly lower in the DPSGC group than in the placebo group (20.6% vs 44.4%; P < 0.05); no patient receiving DPSGC had a serious AE.. DPSGC 25 mg taken every 6 hours was effective in reducing postbunionectomy pain in the patients studied. DPSGC was well tolerated, suggesting that it may be a practicable option for the treatment of mild to moderate acute pain. ClinicalTrials. gov identifier: NCT00366444.

Topics: Acetaminophen; Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Analgesics, Opioid; Anesthesia; Anti-Inflammatory Agents, Non-Steroidal; Capsules; Diclofenac; Double-Blind Method; Female; Gelatin; Hallux Valgus; Humans; Hydrocodone; Male; Middle Aged; Osteotomy; Pain Measurement; Pain, Postoperative; Young Adult

The aim of the study was to evaluate the long-term effect of the use of a pain pump after arthroscopic subacromial decompression.. This prospective, randomized study included 50 patients: 25 patients had a 24-hour pain pump with 0.375% ropivacaine infusion and a continuous rate of 5 mL/h in the subacromial space after arthroscopic subacromial decompression, and 25 patients did not. Rehabilitation was similar in both groups. Evaluation methods were clinical examination, radiographic evaluation, and isometric elevation strength measurements, as well as the University of California, Los Angeles and Constant shoulder scores. All the operations were done by 1 experienced orthopaedic surgeon, and all the evaluations at follow-up were done by 1 independent, blinded examiner. There were no differences between the study groups preoperatively. Of the patients, 47 (94%) were available at a minimum follow-up of 2 years (range, 24 to 32 months).. Concerning the duration of sick leave (P = .053) and ability to return to work (P = .321), the group differences were not statistically significant. At follow-up, the shoulder scores (University of California, Los Angeles and Constant) were significantly better than preoperatively (P < .001) in both groups, although no differences were found between the groups. The isometric elevation strengths of the operated shoulders were equally good in both groups (P = .976) as well, and no significant differences were observed between the operated shoulders and nonoperated shoulders at follow-up.. According to this study, the use of a pain pump after arthroscopic subacromial decompression did not have any long-term effects on the patients' recovery, return to work, or final result at the minimum 2-year follow-up. The results were significantly better at follow-up than preoperatively in both groups.. Level II, prospective, randomized therapeutic study lacking statistical significance and narrow confidence intervals.

Topics: Adult; Amides; Analgesics, Opioid; Decompression, Surgical; Female; Follow-Up Studies; Humans; Hydrocodone; Infusion Pumps, Implantable; Male; Middle Aged; Muscle Strength; Pain Measurement; Pain, Postoperative; Prospective Studies; Ropivacaine; Shoulder Dislocation; Shoulder Impingement Syndrome; Treatment Outcome; Weight-Bearing

To compare the efficacy and tolerability of rofecoxib, hydrocodone/acetaminophen 7.5 mg/750 mg (H/A) and placebo in treating pain after arthroscopy of the knee.. A randomized, double-blind, placebo-controlled, single dose study enrolling patients experiencing moderate or severe pain after knee arthroscopy. Patients with moderate-to-severe postoperative pain received either rofecoxib 50 mg (n = 151), H/A (n = 145), or placebo (n = 147). Pain was measured over 24 h. The primary endpoint was total pain relief at 6 h for rofecoxib 50 mg compared with placebo.. H/A (p = 0.003), but not rofecoxib (p = 0.256) was significantly more effective than placebo for total pain relief at 6 h (TOPAR6). Although analgesic onset and peak were significantly better for H/A than for both rofecoxib (p < 0.01, p < 0.05, respectively) and placebo (p < 0.05, p < 0.001, respectively), rofecoxib patients used significantly less rescue analgesia (p < 0.001) over 24 h. Rofecoxib also provided better Brief Pain Inventory Severity (p = 0.008) and Interference Domain (p = 0.045) scores at 24 h compared to placebo and had lower 24-h Pain Severity scores than H/A (p < 0.05). Treatments were generally well tolerated, with no significant difference in the frequency of patient-reported adverse events between groups.. Rofecoxib 50 mg did not provide significantly different pain relief than placebo at 6 h, and the primary endpoint TOPAR was not attained, although it did show several efficacy benefits at 24 h, including a significant opioid-sparing effect. All treatments were well tolerated, with no significant differences observed. The limited efficacy of rofecoxib in this study contrasts to the results of previous surgical studies evaluating rofecoxib, and may be partially explained by the postoperative dosing in this arthroscopic surgical model.

Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Analysis of Variance; Arthroscopy; Cyclooxygenase 2 Inhibitors; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Hydrocodone; Knee Joint; Lactones; Logistic Models; Male; Pain Measurement; Pain, Postoperative; Sulfones; Treatment Outcome

The search for an effective post-tonsillectomy analgesic has been disappointing. This study tests the hypothesis that rofecoxib improves pain scores in children for 72 hours post-tonsillectomy when compared to hydrocodone with acetaminophen elixir.. Prospective, randomized, double-blind, active comparison of postoperatively administered rofecoxib or hydrocodone with acetaminophen in 60 healthy children scheduled for elective tonsillectomy.. Sixty ASA I and II children scheduled for elective tonsillectomy were enrolled to receive either rofecoxib or hydrocodone with acetaminophen, commencing at discharge from day surgery. Active and passive pain scores and side effects were assessed for 3 days.. Rofecoxib significantly reduced active pain scores at all time intervals after 6 hours following surgery when compared to hydrocodone with acetaminophen without detectable differences in adverse effects. This difference was not apparent in passive pain scores. A review of analgesic strategies is presented. Study results and review of the literature support the development of pediatric formulations of NSAIDs with greater COX-2 selectivity to improve postsurgical pain relief for children.

Topics: Acetaminophen; Adolescent; Ambulatory Surgical Procedures; Analgesics, Non-Narcotic; Analgesics, Opioid; Child; Child, Preschool; Cyclooxygenase 2 Inhibitors; Double-Blind Method; Drug Combinations; Elective Surgical Procedures; Follow-Up Studies; Humans; Hydrocodone; Lactones; Pain Measurement; Pain, Postoperative; Prospective Studies; Sulfones; Time Factors; Tonsillectomy; Treatment Outcome

Continuous femoral nerve blocks have been recommended for postoperative pain control after anterior cruciate ligament reconstruction.. A pain control protocol involving a continuous ropivacaine femoral nerve block will decrease pain and narcotic use in the first 24 hours after surgery compared with a postoperative pain control protocol involving an intra-articular injection of bupivacaine/morphine.. Randomized controlled clinical trial; Level of evidence, 2.. Ninety subjects, aged 15 years or older, who were receiving arthroscopically assisted bone-patellar tendon-bone anterior cruciate ligament reconstruction were randomly assigned to 2 groups. The first group received a ropivacaine continuous femoral nerve block and oral hydrocodone (block group). The second group received an intra-articular bupivacaine/morphine injection and oral oxycodone (injection group). Patients in both groups could receive intramuscular injection of hydromorphone for breakthrough pain; most patients in the block group also received bolus doses of ropivacaine through the femoral catheter. Subjects rated their worst, average, and current pain levels using a visual analog scale and category-ratio scale the morning after surgery. Postoperative narcotic pain medication use was converted to morphine-equivalent doses.. Postoperative pain ratings did not differ between the treatment groups. The largest difference in pain ratings between the groups was 0.5 cm for worst pain level (P = .345). Total narcotic use did not differ significantly between groups (1.1 morphine-equivalent doses in both groups; P = .671).. Continuous femoral block with ropivacaine appeared to have no clinical advantage in the immediate postoperative period after anterior cruciate ligament reconstruction when compared with an intra-articular injection of bupivacaine/morphine. Both methods are effective for pain control after anterior cruciate ligament reconstruction.

Topics: Administration, Oral; Adolescent; Adult; Amides; Analysis of Variance; Anesthetics, Local; Anterior Cruciate Ligament; Anterior Cruciate Ligament Injuries; Arthroscopy; Bone-Patellar Tendon-Bone Grafting; Drug Therapy, Combination; Female; Femoral Nerve; Humans; Hydrocodone; Injections, Intra-Articular; Injections, Intramuscular; Male; Morphine; Narcotics; Nerve Block; Oxycodone; Pain Measurement; Pain, Postoperative; Patient Satisfaction; Ropivacaine; Rupture; Treatment Outcome

Functional endoscopic sinus surgery (FESS) is less invasive and more tissue sparing than extirpative techniques, with an assumed benefit of diminished postoperative pain. Oral opioids are commonly prescribed after sinus surgery but are associated with adverse effects, including gastrointestinal and neurologic symptoms. Nonopioid analgesics have been suggested to offer similar pain control efficacy with fewer adverse effects.. To investigate postoperative analgesia in FESS, a prospective randomized, double-blinded comparison of hydrocodone/acetaminophen 7.5/750 mg (an opioidderivative) with rofecoxib 50 mg (a cyclooxygenase-2 inhibitor) was performed.. Forty subjects were enrolled, of which 28 successfully completed the study. Subjects recorded peak pain levels and requirement for rescue analgesia on the day of surgery and for 4 days thereafter. On postoperative day 5, subjects completed an exit survey in which adverse effects and overall satisfaction with pain control were recorded.. In this study, there were no statistical differences in peak pain levels between the groups at any point in the postoperative period, regardless of extent of surgery. Adverse effect profiles were also similar for the two groups.. The use of nonopioid analgesics after FESS may provide similar pain control to oral opioids.

Topics: Acetaminophen; Adolescent; Adult; Aged; Aged, 80 and over; Analgesia; Analgesics, Non-Narcotic; Analgesics, Opioid; Cyclooxygenase 2 Inhibitors; Double-Blind Method; Endoscopy; Female; Follow-Up Studies; Humans; Hydrocodone; Lactones; Male; Middle Aged; Pain Measurement; Pain, Postoperative; Paranasal Sinus Diseases; Prospective Studies; Sulfones; Treatment Outcome

Sixty-eight patients undergoing outpatient knee arthroscopy for treatment of meniscal tears or loose bodies were divided into three treatment groups (zolpidem [24 patients], control [24 patients], and placebo [20 patients]). All groups received postoperative hydrocodone and ibuprofen. Patients in the zolpidem group received a single dose of zolpidem tartrate for the first seven postoperative nights. Patients in the placebo group received a gelatin capsule similar in appearance to zolpidem and patients in the control group received only hydrocodone and ibuprofen. Patients in the control group demonstrated significantly worse mean daily postoperative pain and more daily postoperative fatigue on visual analog scales when compared with the zolpidem group (P=.03 and P=.04, respectively). Patients in the placebo group had worse daily postoperative pain and more daily postoperative fatigue when compared to the zolpidem group, although these differences did not reach statistical significance (P=.15, power=0.6; and P=.27, power=0.48, respectively). Patients in the control group consumed significantly higher quantities of hydrocodone/acetaminophen postoperatively (P=.04) than patients in the zolpidem group. Finally, patients in the placebo group consumed higher quantities of hydrocodone/acetaminophen than the zolpidem group although the difference did not reach statistical significance (P=.4; power=0.15). Power was calculated for each insignificant relationship based on observed effect and sample sizes and variances. This study demonstrates that sleep and fatigue may be an important factor in the effective pain management following knee arthroscopy. Future postoperative treatment regimens should address sleep and fatigue to maximize analgesic effects in these patients.

Topics: Acetaminophen; Arthroscopy; Double-Blind Method; Drug Combinations; Fatigue; Female; Humans; Hydrocodone; Hypnotics and Sedatives; Joint Loose Bodies; Knee Joint; Male; Middle Aged; Narcotics; Pain Measurement; Pain, Postoperative; Postoperative Period; Prospective Studies; Pyridines; Tibial Meniscus Injuries; Zolpidem

Combination therapy has been widely used for the clinical management of acute pain. By combining 2 drugs with different mechanisms of action, such therapy provides additive analgesic effects while reducing the risk for adverse effects.. This study compared the efficacy and tolerability of oxycodone 5 mg/ibuprofen 400 mg with those of oxycodone 5 mg/acetaminophen 325 mg, hydrocodone 7.5 mg/acetaminophen 500 mg, and placebo in a dental pain model.. This was a multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group, single-dose study in patients experiencing moderate to severe pain after surgical removal of > or = 2 ipsilateral impacted third molars. Patients were randomly assigned to receive oxycodone 5 mg/ibuprofen 400 mg, oxycodone 5 mg/acetaminophen 325 mg, hydrocodone 7.5 mg/acetaminophen 500 mg, or placebo. The primary outcome measures were total pain relief through 6 hours after dosing (TOTPAR6), sum of pain intensity differences through 6 hours (SPID6), and adverse events. Secondary efficacy measures included SPID3 and TOTPAR3, peak pain relief, peak pain intensity difference, time to onset of pain relief, time to use of rescue medication, proportion of patients reporting pain half gone, and the patient's global evaluation.. Two hundred forty-nine patients (43.5% male; 87.5% white; mean age, 19.1 years; mean body weight, 153.6 pounds) were randomized to treatment as follows: 62 to oxycodone 5 mg/ibuprofen 400 mg, 61 to oxycodone 5 mg/acetaminophen 325 mg, 63 to hydrocodone 7.5 mg/acetaminophen 500 mg, and 63 to placebo. Oxycodone 5 mg/ibuprofen 400 mg provided significantly greater analgesia compared with oxycodone 5 mg/acetaminophen 325 mg, hydrocodone 7.5 mg/acetaminophen 500 mg, and placebo (mean [SD] TOTPAR6, 14.98 [5.37], 9.53 [6.77], 8.36 [6.68], and 5.05 [6.49], respectively; P < 0.001, oxycodone 5 mg/ibuprofen 400 mg vs all other treatments). SPID6 values also differed significantly for oxycodone 5 mg/ibuprofen 400 mg compared with all other treatments (mean: 7.78 [4.11], 3.58 [4.64], 3.32 [4.73], and 0.69 [4.85]; P < 0.001). Oxycodone 5 mg/ibuprofen 400 mg was significantly more effective compared with the other treatments on all secondary end points (P < 0.001, all variables except peak PID vs oxycodone 5 mg/acetaminophen 325 mg [P = 0.006]), with the exception of the time to onset of analgesia. The lowest frequency of nausea and vomiting occurred in the groups that received oxycodone 5 mg/ibuprofen 400 mg (6.5% and 3.2%, respectively) and placebo (3.2% and 1.6%). Rates of nausea and vomiting were significantly lower with oxycodone 5 mg/ibuprofen 400 mg compared with oxycodone 5 mg/acetaminophen 325 mg (P = 0.011 and P = 0.009, respectively) but not with hydrocodone 7.5 mg/acetaminophen 500 mg.. In this study in patients with moderate to severe pain after surgery to remove impacted third molars, oxycodone 5 mg/ibuprofen 400 mg provided significantly better analgesia throughout the 6-hour study compared with the other opioid/nonopioid combinations tested, and was associated with fewer adverse events.

Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Drug Combinations; Female; Humans; Hydrocodone; Ibuprofen; Male; Molar, Third; Oxycodone; Pain, Postoperative

Women undergoing postoperative postpartum tubal ligation (PPTL) often experience considerable pain. We hypothesized that epidural morphine, as part of a multi-modal analgesic regimen, would decrease postoperative pain and the need for systemic analgesia after PPTL. In a double-blinded study, patients were randomized to receive epidural saline or morphine 2 mg, 3 mg, or 4 mg after epidural anesthesia for PPTL. Postoperatively, ibuprofen 600 mg was administered every 6 h and patients could request acetaminophen 325 mg/hydrocodone 10 mg. The primary outcome variable was time to first request for supplemental analgesia. Verbal rating scores for pain and the incidence and severity of side effects were recorded for 24 h. Morphine group subjects requested supplemental analgesia later and received fewer doses compared with the saline group subjects. Peak cramping and incisional verbal rating scores for pain and the area under the verbal rating scores for pain x time curve for cramping pain were less after epidural morphine compared with saline, but there were no differences among morphine groups. Nausea, vomiting, and pruritus occurred more often in all morphine groups and subjects who received morphine 4 mg required treatment for these side effects more frequently than the saline or morphine 2 mg groups. In conclusion, epidural morphine 2 mg as part of a multi-modal analgesic regimen improved analgesia and decreased the need for supplemental analgesics after PPTL. The need to treat side effects with morphine 2 mg was not increased compared to a regimen of oral acetaminophen/opioid/nonsteroidal antiinflammatory analgesics.

Topics: Acetaminophen; Administration, Oral; Adult; Analgesia, Epidural; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Female; Humans; Hydrocodone; Ibuprofen; Morphine; Pain Measurement; Pain, Postoperative; Postoperative Nausea and Vomiting; Preanesthetic Medication; Pruritus; Respiratory Mechanics; Sterilization, Tubal

This study assessed the efficacy of local, continuous infusion of bupivacaine for pain control following total knee arthroplasty. Eleven men and 19 women with an average age of 65 years (range: 43-83 years) randomly received either 0.25% bupivacaine or normal saline by local infusion pump. Standard wound drainage also was implemented. Pain was assessed with a visual analog scale along with patient-controlled analgesia demand, narcotic delivery, and nonsteroidal anti-inflammatory administration. Drug lost to drainage also was assessed. Mean preoperative visual analog scores were similar between the saline and bupivacaine groups (6.5 +/- 1.4 and 6.1 +/- 2.0, respectively; P = .535). By the end of the second postoperative day, scores decreased to 3.4 +/- 3.2 for the saline group and 2.5 +/- 1.6 for the bupivacaine group. Although postoperative reductions were statistically significant (P = .007), the main treatment effect was not (P = .404). Mean narcotic demand and usage were 87 +/- 114.1 requests with usage of 11.8 +/- 12.3 mg for the saline group and 96 +/- 104.8 requests with usage of 7.5 +/- 3.8 mg for the bupivacaine group (P = .505). Cumulative ketorolac administration was 47 +/- 52.2 mg for the saline group and 83.6 +/- 64.9 mg for the bupivacaine group (P=.100). Hydrocodone-acetaminophen usage also was similar between the saline and bupivacaine groups (88 +/- 43.9 mg and 64.6 +/- 35 mg, respectively) (P = .112). Drug lost to drainage was estimated to be 27%. These findings suggest continuous local analgesic infusion after total knee arthroplasty does not offer significant improvements in either pain relief or medication use. Drug loss from drainage may exceed 25% and may compromise analgesic effectiveness.

Topics: Acetaminophen; Adult; Aged; Aged, 80 and over; Analgesia, Patient-Controlled; Analgesics, Opioid; Analysis of Variance; Anesthetics, Local; Arthroplasty, Replacement, Knee; Bupivacaine; Female; Humans; Hydrocodone; Infusion Pumps; Ketorolac; Male; Middle Aged; Pain Measurement; Pain, Postoperative; Statistics, Nonparametric

Previous studies have shown that non-steroidal anti-inflammatory drugs (NSAIDs) have significant benefits in the control of postoperative pain after periodontal or oral surgical procedures. The combination of a peripherally acting NSAID with a centrally acting opioid drug is found to be more effective. The purpose of this study was to compare an alternative combination of ibuprofen 400 mg with 5 mg of hydroxycodone to ibuprofen 400 mg used alone in the management of pain following periodontal surgery.. This study used a double-masked cross-over design with the patients acting as their own controls. Twelve patients underwent two periodontal surgeries in different quadrants of the same dental arch at least 2 weeks apart. A standardized amount of local anesthetic and similar extent and duration of surgery for each side was required. The patients received four doses of medication at predetermined intervals and filled out a visual analog pain scale every 2 hours for the first 12 hours after surgery.. The overall pain reported by the patients on visual analog scale was 1.55 (SE +/- 0.16), out of a possible 10. More pain was reported with ibuprofen alone, 1.81 (SE +/- 0.12), compared to the ibuprofen with hydrocodone combination, 1.30 (SE +/- 0.16). The difference was statistically significant (P<0.05).. The findings suggest that a combination analgesic preparation of ibuprofen (400 mg) with hydrocodone (5 mg) results in better pain control compared to ibuprofen used alone.

Topics: Adult; Aged; Analgesics, Opioid; Analysis of Variance; Anti-Inflammatory Agents, Non-Steroidal; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Drug Combinations; Facial Pain; Female; Humans; Hydrocodone; Ibuprofen; Male; Middle Aged; Pain Measurement; Pain, Postoperative; Periodontium

Opioids are associated with numerous adverse effects. It is unclear if reduced postoperative opioid consumption lowers the incidence and severity of opioid-related adverse effects. This analysis -- from a multicenter, randomized, double-blind trial -- tested if the reduction of opioid consumption among patients who received intravenous preoperative parecoxib 40 mg, followed by oral valdecoxib 40 mg qd postoperatively, in Days 1-4 after outpatient laparoscopic cholecystectomy surgery, reduced opioid-related symptoms.. Patients received intravenous fentanyl for pain before discharge, and oral acetaminophen 500 mg hydrocodone 5 mg q 4-6 h prn postdischarge for up to 7 days postsurgery. Patients also received intravenous parecoxib 40 mg administered 30-45 min preoperatively, and valdecoxib 40 mg qd up to Day 4 and prn Days 5-7 postsurgery, or placebo. Patients completed an opioid-related Symptoms Distress Scale (SDS) questionnaire every 24 h for 7 days. Opioid use was converted to morphine-equivalent doses (MEDs). Clinically meaningful events (CMEs) for 12 opioid-related symptoms were assessed by three ordinal measures: frequency, severity, and bothersomeness. Reduction of CMEs on Day 1 and number of patient-days with CMEs on Days 1-4 were examined.. Cumulative MEDs on Day 0, Day 1, and Days 1-4 were significantly lower in the parecoxib/valdecoxib group compared with the placebo group (P < 0.001). At the end of Day 1, parecoxib/valdecoxib-treated patients had significantly lower SDS scores (P < 0.02), a significantly reduced incidence of CMEs (P < 0.05), and significantly fewer patient-days with CMEs in Days 1-4 than placebo patients (P < 0.05). Patients in the parecoxib/valdecoxib group were less likely to have CMEs for multiple symptoms than those in the placebo group (P < 0.001).. Treatment with parecoxib and valdecoxib significantly reduced the cumulative MED requirements, the incidence of opioid-related adverse effects, and patient-days with CMEs.

Topics: Administration, Oral; Adolescent; Adult; Aged; Analgesics, Opioid; Cholecystectomy, Laparoscopic; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Double-Blind Method; Female; Humans; Hydrocodone; Injections, Intravenous; Isoenzymes; Isoxazoles; Male; Membrane Proteins; Middle Aged; Pain Measurement; Pain, Postoperative; Prostaglandin-Endoperoxide Synthases; Sulfonamides

Randomized controlled trials are the gold standard for the evaluation of new therapies and surgical procedures and as such require strict attention to study design and statistical analysis. There are, however, multiple challenges in conducting a well-designed clinical trial. This article describes the difficulties encountered at a single institution participating in a multicenter drug study and reviews the challenges involved in developing a high-quality randomized controlled study.

Topics: Acetaminophen; Adolescent; Adult; Aged; Analgesics; Cholecystectomy, Laparoscopic; Clinical Trials, Phase III as Topic; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Drug Combinations; Humans; Hydrocodone; Informed Consent; Isoenzymes; Membrane Proteins; Middle Aged; Multicenter Studies as Topic; Pain, Postoperative; Patient Selection; Prostaglandin-Endoperoxide Synthases; Randomized Controlled Trials as Topic

Postoperative pain control has received increasing attention by health care providers in the new millennium. In fact, pain was called the "sixth vital sign" by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in 2001. The continued challenge of effective, safe analgesia in the outpatient setting has promoted the use of various devices designed to deliver local anesthetic directly to the surgical site. We endeavored to evaluate the efficacy of one such device currently in use.. Prospective, randomized, placebo-controlled, double-blinded study.. In this study, 49 consecutive patients were prospectively enrolled and randomly assigned to 1 of 3 groups after anterior cruciate ligament (ACL) reconstruction. Patients and investigators were blinded to group assignment. Group 1 (control group) received no catheter. Group 2 (placebo group) received an infusion catheter filled with saline. Group 3 (experimental group) received the same catheter filled with 0.25% bupivacaine solution. All patients received an ipsilateral femoral nerve block with 30 mL 0.25% bupivacaine and 20 mL 0.25% bupivacaine intra-articular injection. Patients recorded narcotic consumption and pain levels on visual analogue scales twice a day for 4 days after surgery. The catheters were removed on day 4 and physical therapy performance was recorded. The patients were then asked to continue to record pain ratings and medication consumption for an additional 4 days after catheter removal. All patients underwent bone-patellar tendon-bone ACL reconstruction by the senior author (P.D.F.). Seven patients were excluded from the study for ineffective femoral nerve block or catheter disconnection or occlusion. Narcotic consumption and the maximum, minimum, and median pain ratings were analyzed by analysis of variance.. Median pain ratings show lower pain levels (P <.03) for both catheter groups versus the control group. No significant differences were found between the catheter groups for the median pain ratings, but lower maximum pain ratings were seen in the bupivacaine group compared with both placebo and no-catheter control subjects. Postoperative narcotic consumption was also lower in both catheter groups versus control subjects (P <.03). Physical therapy data revealed no difference in range of motion on postoperative day 4. More patients were able to perform straight leg raises during the first therapy session in both the saline placebo catheter group (70%) and bupivacaine group (72%) compared with the control group (50%).. The data suggest some element of placebo benefit at median pain ratings but a protective effect of the bupivacaine at maximum pain levels.

Topics: Acetaminophen; Adolescent; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Anterior Cruciate Ligament; Anterior Cruciate Ligament Injuries; Bone Transplantation; Bupivacaine; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Hydrocodone; Ibuprofen; Infusions, Intravenous; Injections, Intra-Articular; Male; Middle Aged; Pain Measurement; Pain, Postoperative; Patellar Ligament; Placebo Effect; Prospective Studies; Reproducibility of Results

Improved clinical outcomes have been documented with combinations of oral analgesic agents, particularly those with complementary activities. However, because not all combinations or dose ratios lead to enhanced analgesia or reduced adverse events (AEs), each combination and dose ratio must be evaluated individually in carefully designed preclinical and clinical trials.. The goal of the study was to compare the efficacy and safety of 37.5 mg tramadol/325 mg acetaminophen tablets (T/APAP), 10 mg hydrocodone bitartrate/650 mg acetaminophen tablets (HC/APAP), and placebo in the treatment of postoperative dental pain.. This was a single-center, double-blind, parallel-group, placebo- and active-controlled study in adults with at least moderate pain (score > or =50 on a 100-mm pain visual analog scale) after extraction of > or =2 impacted third molars. Patients were randomized to receive 1 or 2 T/APAP tablets, 1 HC/APAP tablet, or placebo. Scores for hourly pain relief (PAR), pain intensity difference (PID), and combined PAR and PID (PRID) were based on reported pain at 30 minutes and each successive hour for 8 hours. Primary efficacy measures were summary pain intensity and pain relief scores (total pain relief [TOTPAR], sum of pain intensity differences [SPID], and sum of pain relief and pain intensity differences [SPRIDI) for 0 to 4 hours, 4 to 8 hours, and 0 to 8 hours. Secondary efficacy measures were hourly PAR, PID, and PRID scores; onset and duration of pain relief; time to remedication with a supplemental analgesic agent; and patients' overall assessment of medication.. Two hundred adults took part in the study (50 per treatment group) and were included in the efficacy and safety analyses. T/APAP 75/650 mg and HC/APAP were statistically superior to placebo on the primary efficacy measures of TOTPAR, SPID, and SPRID (P < or = 0.024), as well as on hourly PAR, PID, and PRID over 6 hours (P < or = 0.045). All active treatments were statistically superior to placebo in terms of onset of pain relief (P < or = 0.001), duration of pain relief (P < or = 0.024), time to remedication (P < 0.001), and patients' overall assessment of medication (P < 0.001). A statistically significant dose response with T/APAP (2 tablets > 1 tablet > placebo) was seen for TOTPAR, SPID, and SPRID (all, P < or = 0.018). The median time to onset of pain relief was approximately 34.0 minutes with 2 T/APAP tablets and 25.4 minutes with HC/APAP. Although the median time to onset of pain relief was shorter with HC/APAP, two T/APAP tablets had comparable efficacy to HC/APAP. The median time to remedication with a supplemental analgesic agent was 169.0 minutes in the T/APAP 75/650 mg group and 204.0 minutes in the HC/APAP group. However, the duration of pain relief, as defined by time to remedication, was not significantly different between these 2 groups. The overall incidence of AEs was lower with T/APAP (0% treatment-related AEs) than with HC/APAP (4%) or placebo (10%). The incidence of nausea (18% T/APAP, 36% HC/APAP) and vomiting (12% T/APAP, 30% HC/APAP) was approximately 50% lower with 2 T/APAP tablets than with HC/APAP (P < 0.05).. T/APAP tablets provided effective, rapid (< or = 34 minutes), dose-dependent analgesia for the treatment of postoperative dental pain. Two T/APAP tablets provided analgesia comparable to that provided by HC/APAP with better tolerability.

Topics: Acetaminophen; Adolescent; Adult; Analgesia; Analgesics, Non-Narcotic; Analgesics, Opioid; Double-Blind Method; Drug Combinations; Female; Humans; Hydrocodone; Male; Molar, Third; Pain, Postoperative; Time Factors; Tramadol

To evaluate the effectiveness of an anesthetic continuous-infusion device on postoperative pain after outpatient shoulder surgery.. Double-blinded randomized trial.. A prospective, double-blinded, randomized study of 50 consecutive patients undergoing outpatient arthroscopic shoulder surgery was performed. Patients were assigned by computer-generated randomized permuted block of four to 2 groups (25 each) receiving either a saline or 0.5% bupivacaine solution via an infusion pump after surgery. All patients gave informed consent and were randomized immediately before surgery. The surgical team, patient, clinic staff, and data collector were blinded to the randomization. Procedures performed included arthroscopic rotator cuff repairs, SLAP lesion repairs, subacromial decompressions, and capsular reefings. The infusion pump that was tested was used continuously for 48 hours and administered 2 mL each hour. For subacromial and rotator cuff surgery, the catheter was placed in the subacromial space. For glenohumeral surgery, the catheter was placed in the glenohumeral joint. Routine pain-control efforts were continued. Interviews were conducted at 1, 2, and 8 hours after surgery, followed by daily telephone interviews for 1 week. Visual analog scale (VAS), categorical pain scale (Likert) data, and oral medication use data were recorded.. Complete data sets were collected from 25 bupivacaine and 24 saline patients because 1 pump malfunctioned and was removed early. The average age of the bupivacaine group patients was 47.4 +/- 16.3 years (range, 16 to 84); patients in the saline group had an average age of 46.0 +/- 15.5 years (range, 19 to 73). There were 17 men and 8 women in the bupivacaine group and 16 men and 8 women in the saline group. The Likert and VAS mean values showed lower pain scores for the patients using the pump containing bupivacaine than for the saline group at all recorded times (P <.05) throughout the 7 days of data collection. The interval of greatest pain was on day 2. Postoperative oral medication use was always greater for the saline group than for those receiving bupivacaine.. Postoperative pain control after arthroscopic shoulder surgery is essential so that these procedures can be successfully carried out in an outpatient setting. The first 2 postoperative days is the period of greatest pain. Continuous postoperative bupivacaine infusion is effective during this critical period, and the effect lingers even after the infusion is discontinued. The administration of bupivacaine via a continuous-infusion anesthetic pump statistically reduced postoperative pain after outpatient arthroscopic rotator cuff repairs, SLAP lesion repairs, subacromial decompressions, and capsular reefings.

Topics: Acetaminophen; Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Analgesics, Non-Narcotic; Analgesics, Opioid; Anesthetics, Local; Arthroscopy; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Hydrocodone; Infusion Pumps; Linear Models; Male; Middle Aged; Pain, Postoperative; Prospective Studies; Shoulder

Current outpatient management of postoperative pain includes the use of oral opioid analgesics or nonsteroidal anti-inflammatory drugs; however, both types of medications are associated with side effects that can limit their usefulness in the outpatient setting.. Two studies with identical protocols assessed the single- and multiple-dose analgesic efficacy and tolerability of celecoxib, a specific cyclooxygenase-2 inhibitor, in the treatment of acute pain after orthopedic surgery.. These were multicenter, randomized, placebo- and active-controlled, double-blind, parallel-group trials conducted between January and June 1998. Both consisted of a single-dose assessment period (SDAP) and a multiple-dose assessment period (MDAP). In the SDAP, patients who had undergone orthopedic surgery received a single oral dose of celecoxib 200 mg, hydrocodone 10 mg/acetaminophen 1000 mg, or placebo within 24 hours after the end of anesthesia, with pain assessments conducted over the following 8-hour period. In the MDAP, extending from 8 hours after the first dose of study medication up to 5 days, patients who had received < or =1 dose of rescue medication during the SDAP continued on study medication (placebo recipients were rerandomized to active treatment), which could be taken up to 3 times a day as needed.. A total of 418 patients were enrolled in the 2 trials. During the SDAP, 141 patients received celecoxib, 136 received hydrocodone/acetaminophen, and 141 received placebo. During the MDAP, 185 patients received celecoxib and 181 received hydrocodone/acetaminophen. When the combined data were analyzed, mean pain intensity difference (PID) scores generally favored the active treatments over placebo from 1 to 6 hours (with the exception of 1.5 hours) after dosing (P < or = 0.016) and favored celecoxib over the other treatments at 7 and 8 hours after dosing (P < 0.001). The active treatments demonstrated superior summed PID scores through 8 hours (P < 0.001), significantly shorter median times to onset of analgesia (P < 0.05), and significantly longer median times to first use of rescue medication (P < 0.05). During the MDAP, more hydrocodone/acetaminophen-treated patients (20%) than celecoxib-treated patients (12%) required rescue medication (P < 0.05), and the celecoxib group had significantly lower maximum pain intensity scores (P < 0.001, days 2-5), required fewer doses of study medication (P < or = 0.01, days 3-5), and had superior scores on a modified American Pain Society Patient Outcome Questionnaire (P < or = 0.013). In addition, a significantly lower proportion of celecoxib-treated patients experienced adverse events (43%) compared with hydrocodone/acetaminophen-treated patients (89%; P < 0.001).. Over 8 hours, patients with moderate to severe pain after orthopedic surgery experienced comparable analgesia with single doses of celecoxib and hydrocodone/acetaminophen. Over a 5-day period, oral doses of celecoxib 200 mg taken 3 times a day demonstrated superior analgesia and tolerability compared with hydrocodone 10 mg/acetaminophen 1000 mg taken 3 times a day. Most patients required no more than 2 daily doses of celecoxib 200 mg for the control of their postorthopedic surgical pain.

Topics: Acetaminophen; Adult; Ambulatory Surgical Procedures; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Double-Blind Method; Drug Administration Schedule; Drug Combinations; Female; Humans; Hydrocodone; Male; Middle Aged; Orthopedics; Pain Measurement; Pain, Postoperative; Pyrazoles; Sulfonamides

In recent studies of acute pain and primary dysmenorrhea, rofecoxib, a nonsteroidal anti-inflammatory drug that selectively targets the cyclooxygenase-2 enzyme, was found to be similar in efficacy to ibuprofen and naproxen sodium.. The purpose of this study was to determine the analgesic efficacy of a single oral dose of rofecoxib 50 mg compared with the combination of codeine 60 mg/acetaminophen 600 mg in a model of postsurgical dental pain.. In this double-blind, placebo- and active comparator-controlled, parallel-group study, patients experiencing moderate or severe pain after the surgical extraction of > or = 2 third molars, at least 1 of which was a mandibular impaction, were randomized to receive placebo, rofecoxib 50 mg, or codeine 60 mg/acetaminophen 600 mg. Patient evaluations of pain intensity, pain relief, and global assessments were recorded throughout the 24-hour period after dosing. The 2-stopwatch method was used to determine time to confirmed perceptible pain relief. The primary end point assessing overall analgesic effect was total pain relief over 6 hours (TOPAR6). Secondary end points were patient global assessment of response to therapy (PGART) at 6 hours, onset of analgesia, peak analgesic effect, and duration of analgesia.. A total of 393 patients were enrolled; 182 received rofecoxib, 180 received codeine/acetaminophen, and 31 received placebo. The overall analgesic effect of rofecoxib 50 mg was greater than that of codeine 60 mg/acetaminophen 600 mg for TOPAR6 (12.4 vs 7.0; P < 0.001) and PGART at 6 hours (P < 0.001). The onset of analgesic effect was similar for rofecoxib and codeine/acetaminophen. Peak analgesic effect as measured by peak pain relief scores during the first 6 hours was significantly greater in the rofecoxib group compared with the codeine/acetaminophen group (P < 0.001), as was the duration of analgesic effect measured by the time to rescue analgesia (9.6 hours vs 2.3 hours, P < 0.001). Adverse events were reported in 33.0%, 46.1%, and 32.3% of patients treated with rofecoxib, codeine/acetaminophen, and placebo, respectively. The most common adverse events were nausea (6.0%, 25.0%, and 9.7%, respectively) and vomiting (3.8%, 18.3%, and 6.5%, respectively). Significantly more patients in the codeine/acetaminophen group than in the rofecoxib group experienced adverse events overall (P < 0.050) and nausea in particular (P < 0.001).. In this study of moderate to severe postoperative dental pain, the analgesic efficacy of rofecoxib 50 mg was greater than that of codeine/acetaminophen, with a lower incidence of adverse events and nausea.

Topics: Acetaminophen; Adolescent; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Codeine; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Hydrocodone; Lactones; Male; Pain Measurement; Pain, Postoperative; Sulfones; Time Factors; Tooth Extraction; Treatment Outcome

The purpose of this double-blind, randomized study was to compare the efficacy and safety of a single dose of the following medications: 2 tablets of Vicoprofen (ibuprofen 200 mg/hydrocodone 7.5 mg; Knoll Pharmaceutical Co, Mount Olive, NJ), 2 tablets ofp6 acetaminophen with codeine phosphate (acetaminophen 300 mg/codeine 30 mg), and 2 tablets of placebo in the management of moderate to severe postoperative dental pain after surgical extraction of at least one impacted mandibular third molar.. One hundred twenty-five patients (75 women, 50 men) participated in the study. The time of first perceptible pain relief and meaningful pain relief were measured using a stopwatch technique. Pain intensity and pain relief scores were recorded using standard verbal descriptors at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after dosing. At the conclusion of the study, patients completed a global evaluation for the effectiveness of the study medication.. Both active treatments were superior to placebo for all analgesic measures. Pain relief scores were significantly better for Vicoprofen than placebo throughout the study and significantly better than for acetaminophen with codeine from 2 through 8 hours after dosing. The duration of analgesia (time to remedication) was significantly longer for Vicoprofen (median, 5.50 hours) compared with acetaminophen with codeine (median, 3.03 hours) and placebo (median, 1.00 hours). Mean global evaluation for Vicoprofen was significantly better than for placebo and acetaminophen with codeine. Overall, there were no significant differences in the adverse event profile among the 3 treatment groups.. Vicoprofen was found to be an effective postoperative analgesic medication in the management of acute postoperative dental pain. Its total analgesic effect, duration of analgesia, and global evaluation were superior to acetaminophen with codeine and placebo in this study model.

Topics: Acetaminophen; Adolescent; Adult; Analgesics; Analysis of Variance; Chi-Square Distribution; Codeine; Double-Blind Method; Drug Combinations; Drug Evaluation; Facial Pain; Female; Humans; Hydrocodone; Ibuprofen; Male; Molar, Third; Pain Measurement; Pain, Postoperative; Statistics, Nonparametric; Tooth Extraction; Tooth, Impacted

The objective of this study was to compare the effectiveness of combination hydrocodone and ibuprofen with that of combination oxycodone and acetaminophen in the treatment of moderate to severe postoperative obstetric or gynecologic pain.. Hydrocodone 7.5 mg with ibuprofen 200 mg is the only approved fixed-dose combination analgesic containing an opioid and ibuprofen.. This randomized, double-blind, parallel-group, single-dose, active-comparator, placebo-controlled study compared the effects of a 2-tablet dose of hydrocodone 7.5 mg and ibuprofen 200 mg with those of a 2-tablet dose of oxycodone 5 mg and acetaminophen 325 mg and placebo. Analgesia was assessed over 8 hours.. Mean pain relief (PR) scores were similar for the hydrocodone with ibuprofen and oxycodone with acetaminophen groups (n = 61 and 59, respectively) at 0.5, 1, 1.5, 2, 2.5, 3, 4, and 7 hours and significantly greater for the hydrocodone with ibuprofen group at 5, 6, and 8 hours (P < or = 0.05). Mean pain intensity difference (PID) scores were similar for hydrocodone with ibuprofen and oxycodone with acetaminophen at 0.5, 1, 1.5, 2, 2.5, 3, and 4 hours and significantly greater for hydrocodone with ibuprofen at 5, 6, 7, and 8 hours (P < or = 0.05). Total PR scores were similar for hydrocodone with ibuprofen and oxycodone with acetaminophen for the 0- to 3- and 0- to 4-hour intervals and significantly greater for hydrocodone with ibuprofen for the 0- to 6- and 0- to 8-hour intervals (P < 0.05). The sum of the PID scores was similar for hydrocodone with ibuprofen and oxycodone with acetaminophen for the 0- to 3-, 0- to 4-, 0- to 6-, and 0- to 8-hour intervals. The median estimated time to onset of analgesia, mean peak PR score, median time to remedication, and mean global assessment score were similar for hydrocodone with ibuprofen and oxycodone with acetaminophen. Assay sensitivity was demonstrated by the presence of statistically significant differences between both active treatments and placebo (n = 60). The number of patients experiencing adverse events was similar for each of the 3 groups (11 [18.0%], hydrocodone with ibuprofen; 7 [11.9%], oxycodone with acetaminophen; and 6 [10.0%], placebo).. In this study, a 2-tablet dose of combination hydrocodone 7.5 mg and ibuprofen 200 mg was as effective as a 2-tablet dose of combination oxycodone 5 mg and acetaminophen 325 mg in the treatment of moderate to severe postoperative obstetric or gynecologic pain. Both treatments were superior to placebo. The results of this study suggest that the combination of hydrocodone 7.5 mg and ibuprofen 200 mg may offer prescribers an additional option in combination pain therapy.

Topics: Acetaminophen; Administration, Oral; Adult; Analgesia, Obstetrical; Analgesics, Non-Narcotic; Analgesics, Opioid; Double-Blind Method; Drug Combinations; Female; Gynecologic Surgical Procedures; Humans; Hydrocodone; Ibuprofen; Oxycodone; Pain, Postoperative; Placebos; Tablets

The objective of this study was to demonstrate a dose-response effect with 1- and 2-tablet doses of combination hydrocodone 7.5 mg with ibuprofen 200 mg and placebo in patients with moderate to severe postoperative abdominal or gynecologic pain.. Hydrocodone 7.5 mg with ibuprofen 200 mg is the only approved fixed-dose combination analgesic containing an opioid and ibuprofen. Previous studies with this combination have demonstrated that the components have an additive analgesic effect as well as efficacy compared with other fixed-dose combination analgesics.. This randomized, parallel-group, double-blind, single-dose, placebo-controlled study compared 1 tablet of hydrocodone 7.5 mg with ibuprofen 200 mg (n = 60), 2 tablets of hydrocodone 7.5 mg with ibuprofen 200 mg (n = 60), and placebo (n = 60) in patients with moderate or severe pain after abdominal or gynecologic surgery. Analgesia was evaluated over 8 hours.. Mean pain relief (PR) scores were significantly greater for the 2-tablet dose than for the 1-tablet dose at 80 (P = 0.027) and 100 (P = 0.017) minutes and at 2 (P = 0.013), 2.5 (P = 0.012), 3 (P = 0.006), 4 (P = 0.029), 5 (P = 0.002), 6 (P = 0.032), 7 (P = 0.036), and 8 (P = 0.01) hours. Mean pain intensity difference scores were significantly greater for the 2-tablet dose than for the 1-tablet dose at 80 (P = 0.013) and 100 (P = 0.007) minutes and at 2 (P = 0.003), 2.5 (P = 0.002), 3 (P = 0.002), 4 (P = 0.009), 5 (P < 0.001), 6 (P = 0.004), 7 (P = 0.009), and 8 (P = 0.001) hours. Mean total PR scores were significantly greater for the 2-tablet dose than for the 1-tablet dose for all measured time intervals (0 to 3 hours, P = 0.01; 0 to 4 hours, P = 0.006; 0 to 6 hours, P = 0.003; 0 to 8 hours, P = 0.003). Mean sum of pain intensity differences was significantly greater for the 2-tablet dose than for the 1-tablet dose for all measured time intervals (0 to 3 hours, P = 0.004; 0 to 4 hours, P < 0.001; 0 to 6 hours, P < 0.001; 0 to 8 hours, P < 0.001). Mean peak PR score and median time-to-remedication were significantly greater for the 2-tablet dose than for the 1-tablet dose (P < 0.029 and P = 0.017, respectively). Both doses were superior to placebo. There were no significant differences in the number of patients experiencing adverse events between the 2-tablet dose (n = 6 [10.0%]), the 1-tablet dose (n = 4 [6.7%]), and placebo (n = 1 11.7%]). Adverse events were not serious, and none of the patients discontinued therapy because of side effects.. This study demonstrated that a 2-tablet dose of hydrocodone with ibuprofen provided significantly more analgesia than a 1-tablet dose (a positive dose-response effect) and that both doses were superior to placebo.

Topics: Dose-Response Relationship, Drug; Double-Blind Method; Drug Combinations; Humans; Hydrocodone; Ibuprofen; Pain, Postoperative; Placebos

Two randomized, double-blind, parallel-group single-dose 2 x 2 factorial analgesic studies compared a single-dose or a 2-tablet dose of a combination of 7.5 mg hydrocodone bitartrate with 200 mg ibuprofen with each constituent alone and with a placebo in women with moderate or severe postoperative pain from abdominal or gynecologic surgery. A nurse-observer recorded patient reports of pain intensity and pain relief periodically for 8 hours. In both studies, the combination was significantly superior to placebo for sum of the pain intensity differences (SPID), total pain relief (TOTPAR), peak pain intensity difference (PID) and pain relief, global evaluation, and time to remedication. The combination was likewise significantly superior to both hydrocodone and ibuprofen for most of these summary measures of analgesia. In a factorial analysis, both the hydrocodone and ibuprofen effects were significant for most summary measures of analgesia, whereas results of the interaction contrast were consistent with the concept that the analgesic effect of the combination represents the additive analgesia of its 2 constituents.

Topics: Adult; Aged; Analgesics, Non-Narcotic; Analgesics, Opioid; Double-Blind Method; Drug Synergism; Drug Therapy, Combination; Female; Humans; Hydrocodone; Ibuprofen; Middle Aged; Pain Measurement; Pain, Postoperative; Time Factors; Treatment Outcome

Very small doses of intrathecal (i.t.) morphine (25-200 microg) have been used in an effort to provide effective postoperative pain relief while minimizing side effects after cesarean delivery. We performed a double-blinded study in 40 patients presenting for elective cesarean delivery in which i.t. morphine was administered along with oral hydrocodone/acetaminophen and other medications commonly administered after cesarean delivery. We administered i.t. morphine by up-down sequential allocation of doses. For the purposes of this study, adequate postoperative analgesia was defined as comfort not requiring i.v. morphine for 12 h after spinal anesthesia with bupivacaine, fentanyl, and morphine. In addition, a time and cost comparison was performed for study patients receiving intrathecal morphine compared with a historical group of patients receiving patient-controlled analgesia with i.v. morphine. We were unable to determine with meaningful precision a dose of i.t. morphine to provide analgesia in this context. However, very small doses of i.t. morphine combined with oral hydrocodone/acetaminophen and other medications commonly prescribed after cesarean delivery provided postoperative pain relief with no more time commitment than patient-controlled analgesia (148 +/- 61 vs 150 +/- 57 min) and with significantly less acquisition cost ($15.13 +/- $4.40 vs $34.64 +/- $15.55).. When used along with oral analgesics, very small doses of spinal morphine provide adequate pain relief after cesarean delivery. Spinal anesthetics, oral analgesics, and other medications commonly prescribed to treat side effects after cesarean delivery contribute significantly to this analgesia. When small doses of spinal morphine are used in this setting, they provide adequate analgesia and patient satisfaction that is time- and cost-effective.

Topics: Acetaminophen; Administration, Oral; Analgesia, Epidural; Analgesia, Obstetrical; Analgesia, Patient-Controlled; Analgesics, Non-Narcotic; Analgesics, Opioid; Anesthesia, Obstetrical; Anesthesia, Spinal; Anesthetics, Intravenous; Anesthetics, Local; Bupivacaine; Cesarean Section; Costs and Cost Analysis; Double-Blind Method; Elective Surgical Procedures; Female; Fentanyl; Humans; Hydrocodone; Injections, Spinal; Morphine; Pain, Postoperative; Patient Satisfaction; Pregnancy

This prospective, randomized study evaluated continuous-flow cold therapy for postoperative pain in outpatient arthroscopic anterior cruciate ligament (ACL) reconstructions. In group 1, cold therapy was constant for 3 days then as needed in days 4 through 7. Group 2 had no cold therapy. Evaluations and diaries were kept at 1, 2, and 8 hours after surgery, and then daily. Pain was assessed using the VAS and Likert scales. There were 51 cold and 49 noncold patients included. Continuous passive movement (CPM) use averaged 54 hours for cold and 41 hours for noncold groups (P=.003). Prone hangs were done for 192 minutes in the cold group and 151 minutes in the noncold group. Motion at 1 week averaged 5/88 for the cold group and 5/79 the noncold group. The noncold group average visual analog scale (VAS) pain and Likert pain scores were always greater than the cold group. The noncold group average Vicodin use (Knoll, Mt. Olive, NJ) was always greater than the cold group use (P=.001). Continuous-flow cold therapy lowered VAS and Likert scores, reduced Vicodin use, increased prone hangs, CPM, and knee flexion. Continuous-flow cold therapy is safe and effective for outpatient ACL reconstruction reducing pain medication requirements.

Topics: Acetaminophen; Adult; Ambulatory Surgical Procedures; Analgesics; Analgesics, Opioid; Anterior Cruciate Ligament; Anterior Cruciate Ligament Injuries; Arthroscopy; Cryotherapy; Drug Combinations; Endoscopy; Female; Humans; Hydrocodone; Male; Motion Therapy, Continuous Passive; Oxycodone; Pain Measurement; Pain, Postoperative; Plastic Surgery Procedures; Prospective Studies; Time Factors

The analgesic effectiveness of ketorolac tromethamine was compared with hydrocodone and acetaminophen for pain from an arthroscopically assisted patellar-tendon autograft anterior cruciate ligament reconstruction. There were 125 patients evaluated in a double-blind, randomized, multicenter, and multidose study. A loading dose of parental ketorolac tromethamine was administered and subjects were later given two staged doses of the same "unknown" drug with pain evaluations conducted after each dose. For group 1, dose 1 consisted of ketorolac tromethamine 20 mg orally and dose 2 was ketorolac tromethamine 10 mg. For group 2, both dose 1 and dose 2 consisted of hydrocodone 10 mg plus acetaminophen 1,000 mg orally. Efficacy was evaluated by standard analgesic measures. Subjects treated as outpatients showed lower categorical pain intensity for ketorolac tromethamine than hydrocodone and acetaminophen at 1 hour (P=.03), 2 hours (P=.006), and 3 hours (P=.02); lower summed intensity differences for ketorolac tromethamine than hydrocodone and acetaminophen at 3 hours (P=.014) and 4 hours (P=.019); and better total pain relief for ketorolac tromethamine than hydrocodone and acetaminophen at 3 hours (P=.014) and 4 hours (P=.013). With an effective loading dose administered before the subsequent oral dosage, there was statistically better pain reduction with ketorolac tromethamine than with hydrocodone and acetaminophen. Moreover, ketorolac tromethamine was no more likely to cause digestive complaints than hydrocodone and acetaminophen. No bleeding problems were observed in either group. In the outpatient setting, ketorolac tromethamine controls postoperative pain better than hydrocodone and acetaminophen in the immediate postsurgery period.

Topics: Adolescent; Adult; Analgesics, Non-Narcotic; Analgesics, Opioid; Anterior Cruciate Ligament; Anterior Cruciate Ligament Injuries; Arthroscopy; Double-Blind Method; Endoscopy; Female; Humans; Hydrocodone; Ketorolac Tromethamine; Knee Injuries; Male; Middle Aged; Pain, Postoperative; Tolmetin; Treatment Outcome; Tromethamine

This multicenter study compared the analgesic efficacy and side effects of ketorolac and hydrocodone-acetaminophen when administered orally after ambulatory arthroscopic or laparoscopic tubal ligation procedures. After awakening from general anesthesia, 252 patients experiencing moderate or severe postoperative pain were randomly assigned to receive one of three analgesic treatments according to a placebo-controlled, double-blind protocol. Group 1 (n = 83) received oral ketorolac 10 mg every 6 h for up to 3 days, Group 2 (n = 82) received hydrocodone 7.5 mg plus acetaminophen 750 mg every 6 h for up to 3 days, and Group 3 (n = 87) received placebo capsules followed by ketorolac 10 mg every 6 h for up to 3 days. Severity of pain was recorded using a 4-point categorical score and visual analog scale (VAS) at 0.5 h and subsequently at hourly intervals for 6 h, as well as daily for up to 3 days. Pain relief was recorded using a 5-point categorical scale at the same time points. In the patients undergoing arthroscopic surgery, both ketorolac and hydromorphone-acetaminophen provided superior pain relief compared with the placebo. Although the categorical summed pain intensity difference (SPID), VAS SPID, and total pain relief scores were higher in the ketorolac group compared with the hydrocodone-acetaminophen group, the differences were not statistically significant. In the patients undergoing laparoscopic tubal ligation surgery, the three treatment groups displayed similar responses to the study medications. However, the ketorolac group scored higher in terms of overall tolerability than the hydrocodone-acetaminophen group. In conclusion, there was no difference in the efficacy between oral ketorolac and hydrocodone-acetaminophen combination in controlling pain after outpatient arthroscopic surgery procedures. Neither oral analgesic proved to be very effective after laparoscopic tubal ligation.

Topics: Acetaminophen; Administration, Oral; Adult; Ambulatory Surgical Procedures; Analgesics, Non-Narcotic; Analgesics, Opioid; Arthroscopy; Double-Blind Method; Drug Therapy, Combination; Endoscopy; Female; Humans; Hydrocodone; Ketorolac; Male; Pain Measurement; Pain, Postoperative; Sterilization, Tubal; Tolmetin

The aim of this study was to compare ketoprofen to acetaminophen with hydrocodone (A/H) in a postoperative periodontal pain model. A double-blind protocol was used. Thirty minutes prior to each procedure, subjects were given orally either 100 mg ketoprofen or a placebo tablet. Four hours later, the subjects took either 50 mg ketoprofen (ketoprofen group) or 1000 mg acetaminophen with 10 mg hydrocodone (placebo group). Subjects reported levels of overall discomfort and pain using visual analog scales at eight hourly intervals following the first dose of ketoprofen or placebo. Information about adverse side effects was requested from the patients in the form of a checklist. The results revealed only small differences between the two drug regimens with respect to levels of pain or overall discomfort. A/H provided significantly better pain relief at Hours 5 and 6, while overall discomfort levels were significantly higher with ketoprofen than with placebo at Hours 3 and 4. Pain levels were low for both groups. It is recommended that additional analgesics for mild to moderate pain should be tested.

Topics: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Anesthesia, Dental; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Humans; Hydrocodone; Ketoprofen; Pain, Postoperative; Palliative Care; Periodontal Diseases; Pilot Projects

Hydrocodone is a semisynthetic opioid with analgesic and antitussive properties qualitatively similar to other opioid agonists. Ibuprofen is a nonsteroidal antiinflammatory agent with analgesic and antipyretic activity and is an effective, primarily peripheral-acting antiinflammatory analgesic. The objective of this clinical trial was to determine the additive analgesic effect of the combination of 15 mg hydrocodone bitartrate with 400 mg ibuprofen, relative to 400 mg ibuprofen alone and placebo, in the treatment of postoperative pain. The single-dose analgesic efficacy of the combination of hydrocodone bitartrate with ibuprofen was compared with ibuprofen alone and placebo in 120 patients with moderate or severe postoperative pain after abdominal surgery. Analgesia was measured during the 6-hour period after dosing based on onset of relief, hourly and summary variables, and duration of effect. A significantly greater proportion of patients treated with the hydrocodone/ibuprofen combination reported onset of relief compared with ibuprofen or placebo; however, the distribution functions for time to onset of relief did not differ among treatments. Hydrocodone with ibuprofen and ibuprofen alone were significantly more effective than placebo for all measures of analgesia. The combination of hydrocodone with ibuprofen was significantly superior to ibuprofen for all hourly analgesic evaluations, weighted sum of pain intensity differences (SPID), total pain relief (TOTPAR), and global rating of study medication. No patients in the hydrocodone with ibuprofen group required analgesic remedication during the 6-hour study period, compared with 25% and 82% in the ibuprofen and placebo groups, respectively. The analgesic superiority of 15 mg hydrocodone bitartrate combined with 400 mg ibuprofen compared with 400 mg ibuprofen alone was demonstrated across many efficacy variables.

Topics: Adolescent; Adult; Analgesia, Obstetrical; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Cesarean Section; Double-Blind Method; Drug Combinations; Female; Humans; Hydrocodone; Ibuprofen; Labor, Obstetric; Pain, Postoperative; Pregnancy; Treatment Outcome

A single blind study of 24 patients compared the postoperative periodontal pain relief and adverse effects associated with a pretreatment regimen with etodolac, a nonsteroidal anti-inflammatory drug (NSAID), to a typical pro re nada (prn) regimen with a combination of acetaminophen with hydrocodone. Patients selected required one or more periodontal osseous surgeries that were judged to involve relatively similar degrees of surgical manipulation. Patients in the etodolac group received two 300 mg capsules 30 minutes prior to surgery and then redosed themselves prn. Patients who received the combination drug were not premedicated and followed a prn regimen. The subjects used a verbal analogue scale to report levels of pain hourly for the first 8 hours (starting 30 minutes prior to surgery) and also indicated any side effects experienced during the first week after surgery. Specific parameters monitored were the mean sum of hourly pain scores, mean hourly pain scores, time to first medication, number of postoperative doses, and adverse effects. Of the parameters studied, the only one that showed a statistically significant difference was the time to first medication. The time span from 30 minutes prior to the beginning of surgery to the first postsurgical dose was greater for etodolac than for the combination drug. However, the total number of medications taken under both regimens was similar. The side effects were minimal for both of the drugs studied. It was concluded that the analgesic regimens tested under clinical practice conditions were comparable in providing analgesia with minimum side effects in uncomplicated periodontal osseous surgery. Studies with larger numbers of patients are needed to definitively address whether these regimens are truly equivalent.

Topics: Acetaminophen; Administration, Oral; Adult; Alveolectomy; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Capsules; Drug Combinations; Etodolac; Female; Humans; Hydrocodone; Male; Pain Measurement; Pain, Postoperative; Periodontal Diseases; Premedication; Time Factors

The analgesic efficacy of a hydrocodone-acetaminophen combination, a codeine-acetaminophen combination, a codeine-APC (aspirin, phenacetin, and caffeine) combination, and a placebo was evaluated in outpatients who had moderate or severe pain after the surgical removal of impacted third molars. Each of the active medications had a significant effect on essentially all measures of total and peak analgesia; they did not differ significantly on any measure of analgesia. Adverse effects were transitory and, in general, appear to have been related to the centrally acting component of each combination analgesic.

Topics: Acetaminophen; Adolescent; Adult; Analgesics; Aspirin; Codeine; Drug Combinations; Female; Humans; Hydrocodone; Male; Molar; Pain, Postoperative; Phenacetin

This study investigates the impact of postoperative gabapentin on opioid consumption and pain control following endoscopic sinus surgery (ESS) and/or septoplasty.. Patients who underwent ESS and/or septoplasty at a single institution from 2021 to 2022 were enrolled. All patients received postoperative hydrocodone-acetaminophen for pain control. Half of the patients were also prescribed gabapentin for the first postoperative day in addition to hydrocodone-acetaminophen. Subjects completed the Revised American Pain Society Patient Outcome Questionnaire 24 h and 7 days after surgery. We conducted a multivariable regression analysis to assess opioid consumption and improvement in pain scores in the first week between gabapentin and non-gabapentin groups.. A total of 102 subjects, 51 in each arm, were enrolled. The mean age was 52 years and 53% of participants were female. Controlling for important baseline demographic, clinical, and surgically related variables, the addition of postoperative gabapentin was associated with a 44% (9.5 mg from 21.6 mg) reduction in opioids consumed in the first postoperative week (B = -9.54, 95% C.I. = [-17.84, -1.24], p = 0.025). In addition, patients in both arms exhibited similar improvement in pain severity and sleep interference in the first 7 days (B = -1.59, 95% C.I. = [-5.03, 1.84], p = 0.36).. To the best of our knowledge, this is the first study to investigate the impact of postoperative gabapentin on opioid consumption and pain control following ESS and/or septoplasty. Our analysis demonstrated that postoperative gabapentin effectively reduced opioid use during the first postoperative week without compromising pain control.. 3 Laryngoscope, 133:1065-1072, 2023.

Topics: Acetaminophen; Analgesics, Opioid; Female; Gabapentin; Humans; Hydrocodone; Male; Middle Aged; Pain Management; Pain, Postoperative

Topics: Analgesics, Opioid; Celecoxib; Humans; Hydrocodone; Oxycodone; Pain; Pain, Postoperative; Tramadol

Veterans have disproportionate risk of opioid misuse and abuse compared to the civilian population. Managing acute postoperative pain without opioids is of the utmost importance for the Veteran patient population. This pilot study evaluates a novel multimodal opioid-free pain control regimen by assessing postoperative pain in Veterans undergoing robotic-assisted radical prostatectomy (RARP).. Prospective data was collected from patients undergoing RARP at a Department of Veterans Affairs Medical Center. Patients in the opioid-cohort received tramadol, hydrocodone-acetaminophen, or oxycodone-acetaminophen postoperatively. The opioid-free novel multimodal approach consisted of 100 mg gabapentin TID, 15 mg ketorolac Q6 hours, and 1 mg scheduled IV acetaminophen Q6 hours. Pain scores were collected using a visual analogue pain scale on postoperative days 0 and 1.. Data was collected from 57 patients, 33 treated with opioids and 24 with the opioid-free pathway. There were no significant differences in demographics (P > .05) between cohorts. No significant differences were observed for preoperative and intraoperative variables (P > .05). Average postoperative day 0 pain scores for opioid-free (2.2 ± 3.1) and opioid treatments (3.1 ± 3.1) were not statistically different (P = .1321). Postoperative day 1 differences of average pain scores for opioid-free (0.9 ± 1.9) and opioid (1.6 ± 3.1) treatments were not statistically significant (P = .1647).. The novel multimodal opioid-free treatment in this study may be effectively utilized for postoperative pain during hospital recovery of Veterans undergoing RARP. Future directions include a randomized control clinical trial in the general population.

Topics: Acetaminophen; Analgesics, Opioid; Gabapentin; Humans; Hydrocodone; Ketorolac; Male; Pain, Postoperative; Pilot Projects; Prospective Studies; Prostatectomy; Robotic Surgical Procedures; Tramadol; Veterans

To determine the incidence of and predictors for serious opioid-related adverse drug events (ORADEs) in postoperative inpatients.. A retrospective cohort study design of serious ORADEs in surgical inpatients between 2015 and 2017, who were abstracted from the electronic health record, in an 800-bed academic medical health center.. A total of 27,942 surgery patients met the inclusion criteria. Of those, 25,208 patients (90%) were exposed to opioids after surgery. A total of 25,133 (99.7%) patients exposed to opioids did not experience a serious ORADE while 75 (0.3%) patients did experience a serious ORADE and required naloxone. The predictors for ORADEs include age (OR = 1.040, P-value < .0001); gender (OR = 0.394, P-value = .0006); psychiatric disorder (OR = 4.440, CI: 2.435, 8.095); morphine level with respect to hydrocodone-acetaminophen (OR = 5.841, P-value = .0384); and were almost six times more likely to experience a serious ORADE when morphine is prescribed and 4.44 times more likely in patients with a psychiatric disorder (P-value < .0001).. Once a baseline incidence is known, predictors for serious ORADEs in surgical inpatients are useful in guiding medical-surgical nurses' opioid safety practices, with more frequent focused respiratory assessments before opioid dosing and closer monitoring when opioids are prescribed postoperatively, especially in higher-risk surgical inpatients.

Topics: Acetaminophen; Analgesics, Opioid; Drug-Related Side Effects and Adverse Reactions; Humans; Hydrocodone; Incidence; Length of Stay; Naloxone; Pain, Postoperative; Retrospective Studies

This study was designed to test the hypothesis that patients prescribed hydrocodone consume a similar number of tablets as those prescribed oxycodone after surgery.. In October 2017, the Michigan Opioid Prescribing Engagement Network released opioid prescribing guidelines for surgeries. For each procedure, these guidelines recommended prescribing 50% more tablets of hydrocodone than tablets of oxycodone to adjust for potency differences. These guidelines were simplified in January 2019 to recommend the same number of 5 mg hydrocodone tablets as 5 mg oxycodone tablets for each procedure.. Retrospective, observational analysis of opioid-naïve adults who underwent surgical procedures across 64 hospitals in Michigan and were prescribed 5 mg tablets of hydrocodone or oxycodone between January 1, 2018 and May 31, 2019. The primary outcome was number of tablets consumed. We defined a meaningful difference in consumption as 5 pills a priori. Secondary outcomes included self-reported pain, satisfaction, and opioid refills.. A total of 6842 patients were included. Adjusting for covariates, patients prescribed hydrocodone consumed 7 tablets (95% confidence interval 6.79-7.18) while patients prescribed oxycodone consumed 6 tablets (95% confidence interval 5.58-6.40.) Comparing patients prescribed oxycodone with those prescribed hydrocodone, there were no differences in satisfaction, pain, or refills.. Although patients prescribed hydrocodone consumed more tablets than patients prescribed oxycodone, this difference was not clinically significant and did not result in differences in satisfaction, pain, or refills. Perioperative opioid prescribing guidelines may recommend the same number of 5 mg oxycodone and hydrocodone tablets without sacrificing patient-reported outcomes.

Topics: Adult; Analgesics, Opioid; Humans; Hydrocodone; Oxycodone; Pain, Postoperative; Practice Patterns, Physicians'; Retrospective Studies

Historically, opioid pain medications have been overprescribed following thyroid and parathyroid surgery. Many narcotic prescriptions are incompletely consumed, creating waste and opportunities for abuse.. To determine whether limiting opioid prescriptions after outpatient thyroid and parathyroid surgery to patients who opt in to narcotic treatment reduces opioid consumption without increasing postoperative pain compared with usual care (routine narcotic prescriptions).. A randomized clinical trial of Postoperative Opt-In Narcotic Treatment (POINT) or routine narcotic prescription (control) was conducted at a single tertiary referral center from June 1 to December 30, 2020. A total of 180 adults undergoing ambulatory cervical endocrine surgery, excluding patients currently receiving opioids, were assessed for eligibility. POINT patients received perioperative pain management counseling and were prescribed opioids only on patient request. Patients reported pain scores (0-10) and medication use through 7 daily postoperative surveys. Logistic regression was used to determine factors associated with opioid consumption.. Patients in the POINT group were able to opt in or out of receiving prescriptions for opioid pain medication on discharge. Control patients received routine opioid prescriptions on discharge.. Daily peak pain score through postoperative day 7 was the primary outcome. Noninferiority was defined as a difference less than 2 on an 11-point numeric rating scale from 0 to 10. Analysis was conducted on the evaluable population.. Of the 180 patients assessed for eligibility, the final study cohort comprised 102 patients: 48 randomized to POINT and 54 to control. Of these, 79 patients (77.5%) were women and median age was 52 (interquartile range, 43-62) years. A total of 550 opioid tablets were prescribed to the control group, and 230 tablets were prescribed to the POINT group, in which 23 patients (47.9%) opted in for an opioid prescription. None who opted out subsequently required rescue opioids. In the first postoperative week, 17 POINT patients (35.4% of survey responders in the POINT group) reported consuming opioids compared with 27 (50.0%) control patients (P = .16). Median peak outpatient pain scores were 6 (interquartile range, 4-8) in the control group vs 6 (interquartile range, 5-7) in the POINT group (P = .71). In multivariate analysis, patients with a history of narcotic use were 7.5 times more likely to opt in (95% CI, 1.61-50.11; P = .02) and 4.8 times more likely to consume opioids (95% CI, 1.04-1.52; P = .01). Higher body mass index (odds ratio, 1.11; 95% CI, 1.01-1.23; P = .03) and highest inpatient postoperative pain score (odds ratio, 1.24; 95% CI, 1.04-1.52; P = .02) were also associated with opioid consumption.. In this trial, an opt-in strategy for postoperative narcotics reduced opioid prescription without increasing pain after cervical endocrine surgery.. ClinicalTrials.gov Identifier: NCT04710069.

Topics: Acetaminophen; Adult; Aged; Ambulatory Surgical Procedures; Analgesics, Non-Narcotic; Analgesics, Opioid; Codeine; Female; Humans; Hydrocodone; Male; Middle Aged; Pain Measurement; Pain, Postoperative; Parathyroidectomy; Patient Preference; Patient-Centered Care; Quality of Life; Thyroidectomy; Tramadol

To determine whether a postoperative prescription for opioids affects parental assessment of pain control following pediatric circumcision.. This postoperative survey assessed the parental assessment of pain control in 199 patients, ages<18 years undergoing circumcision. This study was conducted at a quaternary care children's hospital in Houston, Texas from December 2018 to January 2020. Postoperative pain regimens included acetaminophen and ibuprofen or combination hydrocodone/acetaminophen in addition to ibuprofen for postoperative analgesia based on the surgical preference. The primary study outcome was identification of the proportion of parents rating their child's analgesia following pediatric circumcision as poor or inadequate based on the postoperative analgesic regimen.. Of the 502 surveys sent, the response rate was 40% (199/502) of those who received the survey email, and 64% (199/308) for those who opened the email. Between the opioid and nonopioid groups, there was no difference in, race/ethnicity (Caucasian; 28% vs 37%; P = .43) or insurance status (insured; 51% vs 45%; P = .44). The proportion of parents who rated their child's pain as poor or inadequately controlled following circumcision was relatively rare:5.5% and 1.1% in the nonopioid and opioid groups, respectively. Parents rating their child's pain as excellent with regards to pain control following circumcision were 61% and 53% in the nonopioids and opioid groups, respectively.. The results of this study indicate that nonopioid analgesic regimens following pediatric circumcision were not associated with decreased parental satisfaction or an increasing assessment of poor or inadequately controlled pain. Limiting opioid exposure following pediatric circumcision is feasible and does not result in worse parental satisfaction with the analgesic plan.

Topics: Acetaminophen; Adolescent; Analgesics, Non-Narcotic; Analgesics, Opioid; Child; Child, Preschool; Circumcision, Male; Drug Combinations; Drug Therapy, Combination; Humans; Hydrocodone; Ibuprofen; Infant; Male; Pain Measurement; Pain, Postoperative; Parents; Patient Satisfaction; Surveys and Questionnaires

To describe opioid stewardship in ambulatory otologic surgery from 2005 to 2017.. Descriptive study of US private insurance claims.. Nationwide deidentified private insurance claims database (Clinformatics DataMart; Optum).. A total of 17,431 adult opioid-naïve outpatients were included in the study. Patients were identified from. The mean prescribed perioperative dose over the examined period was 203.03 MMEs (95% CI, 200.27-205.79; 5-mg hydrocodone pill equivalents, 40.61). In multivariate analysis, patients undergoing mastoid surgery were prescribed more opioids than those undergoing middle ear surgery (mean difference, 39.89 MME [95% CI, 34.37-45.41],. While the amount of opioids prescribed perioperatively has declined in recent years, otologists should continue to be cognizant of potential overprescribing in light of previous studies of patients' relatively low opioid intake.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ambulatory Surgical Procedures; Analgesics, Opioid; Drug Prescriptions; Drug Utilization; Female; Humans; Hydrocodone; Male; Middle Aged; Otologic Surgical Procedures; Pain, Postoperative; Retrospective Studies; Time Factors; United States; Young Adult

Hydrocodone is the most prescribed opioid in the US. The objective was to evaluate associations between genetic, intrinsic, and extrinsic patient factors, plasma hydrocodone and metabolites, common side effects, and pain scores in a cohort of orthopedic surgery patients.. Data for each patient was collected by review of the electronic hospital record (EHR), and patient interview. Patients were recruited from those with trauma or undergoing scheduled elective surgery for total knee replacement or total hip at the University of Louisville Hospital, Baptist East Hospital, and Jewish Hospital, Louisville, KY. Plasma opiate concentrations and a targeted genotyping panel was performed.. There were statistically significant correlations with daily (p < 0.001) and total dose (p = 0.002) of hydrocodone in hospital and duration of opioid therapy. The length of opioid administration was significantly shorter in CYP2D6 EM/UM versus CYP2D6 PM/IM patients (p = 0.018). Subjects with the OPRM1 c.118G variant were also on opioids longer (p = 0.022). The effect of co-administration of a CYP2D6 inhibitor had a significant effect on the length of opioid therapy (P < 0.001). And not surprisingly the effect of the inhibitor adjusted CYP2D6 phenotype was greater in both the hospital stay period and days of opioid use post hospital discharge (p < 0.001).. Based on this study, patients should be evaluated for the use of inhibitors of CYP2D6, during hydrocodone therapy can alter the phenotype of the patient (phenocopy) and increase the probability that the patient will be on opioids for longer periods of time.

Topics: Analgesics, Opioid; Cytochrome P-450 CYP2D6; Humans; Hydrocodone; Pain, Postoperative

To examine differences in outcomes after tonsillectomy in children who received outpatient narcotics prescriptions compared to those who did not.. The MarketScan database was analyzed for claims made for 14 days following tonsillectomy/adenotonsillectomy between 2008 and 2012 for privately insured children 1 to 17 years. Post-op bleeding, dehydration, emergency department (ED) visits, readmissions, and mean total costs for the 14 days after tonsillectomy were compared.. Of the 294 795 patients included, 60.9% received a narcotic prescription. Acetaminophen/hydrocodone bitartrate was received by 53.2% of the group receiving narcotic drugs, 42.5% received acetaminophen/codeine phosphate, 3.0% received acetaminophen/oxycodone hydrochloride, and 0.5% received oxycodone hydrochloride alone. Children who had been prescribed narcotics had significantly higher percentages of bleeding complications (2.7% vs 2.5%,. In this large-scale study, we found small but statistically significant differences in outcomes related to use of narcotics. The only outcome that benefitted the narcotics group was a lower readmission rate.

Topics: Acetaminophen; Adolescent; Analgesics; Child; Child, Preschool; Codeine; Databases, Factual; Drug Combinations; Emergency Service, Hospital; Female; Humans; Hydrocodone; Infant; Male; Narcotics; Pain, Postoperative; Patient Readmission; Postoperative Hemorrhage; Prescriptions; Tonsillectomy; Treatment Outcome

There is increasing need to avoid excess opioid prescribing after surgery. We prospectively assessed overprescription in our hospital system and used these data to design a quality improvement intervention to reduce overprescription.. Beginning in January 2017, an e-mail-based survey to assess the quantity of opioids used postoperatively as well as patient-reported pain control was sent to all surgical patients in a 23-hospital system. In January 2018, as a quality improvement initiative, guidelines were given to surgeons based on patient consumption data. Prescription and consumption were then tracked prospectively. Wilcoxon signed-rank, analysis of variance, and Cuzick trend tests were used to assess for overprescription and changes over time in opioid prescribing and consumption.. We included 2239 patients in our cohort. The amount prescribed (median [IQR]: 30 [24-45] versus 18 [12-30], P < 0.001) and consumed (median [IQR]: 12 [7-20] versus 8 [3-15], P < 0.001) each decreased between the first and last quarter studied. Academic hospitals prescribed fewer opioids than nonacademic hospitals (median [IQR]: 24[15-40] versus median [IQR]: 30 [20-45], P < 0.001). There was no difference in the quantity of opioids consumed between patients treated at academic and nonacademic facilities (median [IQR]: 10[3-19] versus 10.5 [4-20], P = 0.08). Patients consumed a median of 42% of the opioids prescribed, and there was no significant trend in the percent consumed over time (P = 0.8).. Patients used far fewer opioids than prescribed after common adult general surgery procedures. When surgeons were provided with patient consumption data, the number of opioids prescribed decreased significantly.

Topics: Adult; Aged; Analgesics, Opioid; Female; Health Plan Implementation; Humans; Hydrocodone; Male; Medical Overuse; Middle Aged; Opioid Epidemic; Pain Management; Pain Measurement; Pain, Postoperative; Patient Reported Outcome Measures; Postoperative Care; Practice Guidelines as Topic; Practice Patterns, Physicians'; Prospective Studies; Quality Improvement; Surgical Procedures, Operative; Tablets

In 2014, the U.S. Drug Enforcement Agency reclassified hydrocodone from Schedule III to Schedule II of the Controlled Substances Act, resulting in new restrictions on refills. The authors hypothesized that hydrocodone rescheduling led to decreases in total opioid dispensing within 30 days of surgery and reduced new long-term opioid dispensing among surgical patients.. The authors studied privately insured, opioid-naïve adults undergoing 10 general or orthopedic surgeries between 2011 and 2015. The authors conducted a differences-in-differences analysis that compared overall opioid dispensing before versus after the rescheduling rule for patients treated by surgeons who frequently prescribed hydrocodone before rescheduling (i.e., patients who were functionally exposed to rescheduling's impact) while adjusting for secular trends via a comparison group of patients treated by surgeons who rarely prescribed hydrocodone (i.e., unexposed patients). The primary outcome was any filled opioid prescription between 90 and 180 days after surgery; secondary outcomes included the 30-day refill rate and the amount of opioids dispensed initially and at 30 days postoperatively.. The sample included 65,136 patients. The percentage of patients filling a prescription beyond 90 days was similar after versus before rescheduling (absolute risk difference, -1.1%; 95% CI, -2.3% to 0.1%; P = 0.084). The authors estimated the rescheduling rule to be associated with a 45.4-mg oral morphine equivalent increase (difference-in-differences estimate; 95% CI, 34.2-56.7 mg; P < 0.001) in initial opioid dispensing, a 4.1% absolute decrease (95% CI, -5.5% to -2.7%; P < 0.001) in refills within 30 days, and a 37.7-mg oral morphine equivalent increase (95% CI, 20.6-54.8 mg; P = 0.008) in opioids dispensed within 30 days.. Among patients treated by surgeons who frequently prescribed hydrocodone before the Drug Enforcement Agency 2014 hydrocodone rescheduling rule, rescheduling did not impact long-term opioid receipt, although it was associated with an increase in opioid dispensing within 30 days of surgery.

Topics: Adult; Analgesics, Opioid; Controlled Substances; Drug and Narcotic Control; Drug Prescriptions; Female; Humans; Hydrocodone; Insurance Claim Review; Male; Middle Aged; Pain, Postoperative; Retrospective Studies; United States

Patient-reported pain scores and opioid use have not been quantified after outpatient adolescent anterior cruciate ligament reconstruction (ACLR).. Patients aged 12 to 18 years undergoing primary isolated ACLR, with or without meniscal treatment, were prospectively recruited. Patients actively taking opioids or with previous extended use of opioids were excluded. Two orthopaedic surgeons performed ACLR and determined the use of a hamstring or bone-patellar tendon-bone autograft. For postoperative pain management, patients were prescribed 40 tablets of hydrocodone/acetaminophen 5/325 mg. Patients were instructed to document daily pill consumption and side effects through a daily log for 6 weeks. Patients completed the American Pain Society Patient Outcome Questionnaire at the end of weeks 1 and 6.. One hundred three patients were enrolled, with age: 12.5 to 18.9 years (mean 16.2 y ± 1.3), weight: 41.3 to 113.6 kg (mean 72.4 kg ± 17.2), and body mass index: 17.8 to 40.1 (mean 25.9 ± 4.9). Sixty-nine patients received a hamstring autograft, and 34 received a bone-patellar tendon-bone autograft. Fifty-six received additional meniscal procedures. The median number of postoperative opioids taken by patients was 17 (range 0 to 40). No notable differences were found in total pill consumption with regard to age, weight, body mass index, sex, block type, autograft type, or meniscal treatment at 1 week post-op or 6 weeks post-op. No correlation was found between the self-reported "worst pain in the past 24 hours" at the end of the first postoperative week or after 6 weeks (r = 0.112, P = 0.26, and r = 0.093, P = 0.36). No correlation was found between the level of satisfaction with pain treatment and total number of pills taken during the first postoperative week or at the end of 6 weeks (r = -0.090, P = 0.37, and r = -0.172, P = 0.08).. Patients take most pain medication during the first postoperative week after adolescent ACLR, although patient and surgical variables had no notable influence on pill consumption.. Level IV, case series.

Topics: Acetaminophen; Adolescent; Age Factors; Analgesics, Opioid; Anterior Cruciate Ligament; Child; Drug Therapy, Combination; Drug Utilization; Female; Humans; Hydrocodone; Male; Orthopedic Procedures; Pain Management; Pain, Postoperative; Patient Reported Outcome Measures; Plastic Surgery Procedures; Prospective Studies; Surveys and Questionnaires; Tablets

Initial opioid exposure for most individuals with substance use disorder comes from the healthcare system, and overprescription of opioids in ambulatory operations is common. This report describes an academic medical center's experience implementing opioid-free thyroid and parathyroid operations.. This is a retrospective chart review of patients undergoing a thyroid or parathyroid operation before and after implementation of an opioid-free analgesia protocol. The primary endpoint was new postoperative opioid prescription. Secondary endpoints included prescription characteristics and predictors of new opioid prescription.. A total of 515 patients were enrolled in the study: 240 in the control or "pre-intervention" cohort (May through October 2017) and 275 in the intervention or "post" cohort (May through October 2018). Patients in the intervention cohort were significantly less likely to receive an opioid prescription (12.0% versus 59.6%, P < 0.001). When opioids were prescribed, they were used for shorter durations and at lower doses in the intervention cohort. Among the patients prescribed opioids in the intervention cohort (N = 33), the only significant predictor of postoperative opioid use was preoperative opioid use (P = 0.001).. Opioids may not be required after thyroidectomy and parathyroidectomy, especially for opioid-naïve patients. Future research should examine patient satisfaction with opioid-sparing analgesia.

Topics: Academic Medical Centers; Acetaminophen; Aged; Analgesics, Opioid; Drug Combinations; Drug Prescriptions; Drug Utilization; Feasibility Studies; Female; Health Plan Implementation; Humans; Hydrocodone; Male; Middle Aged; Opioid Epidemic; Pain Management; Pain Measurement; Pain, Postoperative; Parathyroidectomy; Patient Satisfaction; Practice Patterns, Physicians'; Retrospective Studies; Thyroidectomy; Treatment Outcome

Postoperative prescribing of opioids following pediatric adenotonsillectomy can have negative consequences including unnecessary opioid exposure and potential for respiratory depression. While guidelines from The American Academy of Otolaryngology/Head & Neck Surgery recommend treatment of post adenotonsillectomy pain using acetaminophen and ibuprofen, many providers continue to prescribe opioids and may do so, in part with concern for parental dissatisfaction with post-operative analgesia. Our aim was to determine whether a post-operative prescription for opioids affects parental assessment of pain control following pediatric adenotonsillectomy.. This post-operative survey assessed the parental assessment of pain control in 324 patients, ages 1-17 years undergoing adenotonsillectomy. This study was conducted at a quaternary care children's hospital in Houston, Texas from December 1, 2018 through March 31, 2019. Post-operative pain regimens included acetaminophen and ibuprofen or combination hydrocodone/acetaminophen in addition to ibuprofen for post-operative analgesia based on the attending surgeons prescribing preferences. The primary study outcome was identification of the proportion of parents rating their child's analgesia following pediatric adenotonsillectomy as poor or inadequate based on the post-operative analgesic regimen including opioids.. Of the 798 surveys sent, the response rate was 42% (324/775) of those who received the survey email, and 69% (324/470) for those who opened the email. Between the opioid and non-opioid groups, there was no difference in gender (male; 48% vs. 51.3%; p = 0.58), race/ethnicity (white; 53% vs. 46%; p = 0.35) or insurance status (insured; 62% vs. 50.9%; p = 0.06). The proportion of parents who rated their child's pain as poor or inadequately controlled following adenotonsillectomy was relatively rare: 9% and 5% in the non-opioid and opioid groups, respectively. Parents rating their child's pain as excellent with regards to pain control following adenotonsillectomy were 58% and 50% in the non-opioids and opioid groups respectively.. The results of this study indicate that non-opioid analgesic regimens following pediatric adenotonsillectomy were not associated with decreased parental satisfaction or an increasing assessment of poor or inadequately controlled pain. Limiting opioid exposure following pediatric adenotonsillectomy is feasible and does not result in worse parental satisfaction with the analgesic plan.

Topics: Acetaminophen; Adenoidectomy; Adolescent; Analgesics, Non-Narcotic; Analgesics, Opioid; Child; Child, Preschool; Drug Combinations; Female; Humans; Hydrocodone; Ibuprofen; Infant; Male; Otolaryngology; Pain Management; Pain Measurement; Pain, Postoperative; Parents; Patient Satisfaction; Tonsillectomy

Topics: Acetaminophen; Analgesics, Opioid; Drug Combinations; Humans; Hydrocodone; Ophthalmologic Surgical Procedures; Pain, Postoperative; Pilot Projects; Practice Patterns, Physicians'; Retrospective Studies; Self Report

Post-operative pain is a common concern following elective foot and ankle surgery. NSAIDs used for pain relief have led to bone-healing complications in animal models and in vitro studies. This retrospective study examined the rate of bone-healing complications in post-surgical patients using NSAIDs.. Participants underwent elective foot surgeries between January 2016 and May 2018. Radiographs were used to identify bony nonunion at osteotomy sites 12 weeks post-surgery.. Two-hundred thirty-two patients were evaluated; 59 (25.43%) were prescribed ibuprofen, 62 (27%) ketorolac, 15 (6.47%) acetaminophen, and 92 (40%) hydrocodone-acetaminophen. Two-hundred and twelve (91.38%) patients exhibited radiographic evidence of osseous union at 12 weeks and 20 (8.62%) had radiographic evidence of non-union of the osteotomy sites. There was no significant relationship between NSAID use and osseous non-union (p<0.05).. Short-term use of oral ibuprofen and ketorolac in the post-operative period was not associated with bony non-union.

Topics: Acetaminophen; Adult; Aged; Aged, 80 and over; Ankle Joint; Anti-Inflammatory Agents, Non-Steroidal; Drug Combinations; Female; Foot Joints; Humans; Hydrocodone; Joint Diseases; Ketorolac; Male; Middle Aged; Osteotomy; Pain Management; Pain, Postoperative; Postoperative Care; Retrospective Studies; Young Adult

Genetic polymorphisms of cytochrome P450 are contributors to variability in individual response to drugs. Within the P450 family, CYP2D6 is responsible for metabolizing hydrocodone, a widely prescribed opioid for pain management. Alternatively, CYP3A4 and CYP3A5 can form norhydrocodone and dihydrocodeine. We have previously found that in a postcesarean section cohort, the rate of hydromorphone formation was dependent on the genotype of. Blood was obtained from a postcesarean cohort that were surveyed for pain response and common side effects. Plasma samples were genotyped for. Two-way ANOVA between CYP3A4/A5 and CYP2D6 phenotypes revealed that the former variants did not have a statistical significance on the outcomes, and only CYP2D6 phenotypes had a significant effect on total dosage (. With respect to total dosages in a cesarean section population, these results confirm that CYP2D6 phenotypes are predictors for plasma hydromorphone concentration and pain relief, but CYP3A4/A5 phenotypes have no influence on pain relief or on side effects.

Topics: Analgesics, Opioid; Biomarkers, Pharmacological; Cesarean Section; Cytochrome P-450 CYP2D6; Cytochrome P-450 CYP3A; Dose-Response Relationship, Drug; Female; Humans; Hydrocodone; Hydromorphone; Pain Management; Pain, Postoperative; Pharmacogenomic Testing; Polymorphism, Genetic

Managing postoperative pain is important for patients and surgeons. However, there is concern over opioid dependency. Cubital tunnel decompression is among the most common upper extremity surgeries. Our study aimed to analyze opioid use after cubital tunnel decompression to guide postoperative opioid prescribing.. We prospectively collected opioid consumption for 16 consecutive months (February 2016 to June 2017) for cubital tunnel decompression patients. Data on demographics, insurance type, surgery performed, functional questionnaires (Quick Disabilities of the Arm, Shoulder and Hand [QuickDASH]), and electrodiagnostics (electromyography) were collected. Opioid consumption was reported at first postoperative visits.. One hundred patients consumed a mean of 50 morphine equivalent units (MEUs) (range, 0-300), or 7 oxycodone 5-mg pills, postoperatively. Cubital tunnel release (CuTR) patients consumed fewer than ulnar nerve transposition (UNT) patients (40.4 vs 62.5 MEUs or 5.4 vs 8.3 pills, P = .08). Patients undergoing submuscular UNT consumed more than CuTR (115.0 vs 40.4 MEUs or 15.3 vs 5.4 pills, p = 0.003) and more than subcutaneous UNT patients (37.8 MEU or 5.0 pills, p = 0.03). Medicare patients consumed less than privately insured (42.7 vs 54.1 MEUs, 5.7 vs 7.2 pills, P = .02) and less than workers' compensation patients (76.8 MEU or 10.2 pills, P = .04). Older patients consumed fewer than younger patients ( P = .03). Postoperative QuickDASH score was positively related to opioid intake ( P = .009).. Patients consumed 7 oxycodone 5-mg pills after cubital tunnel decompression. Younger, privately insured, and workers' compensation patients, and those with worse functional scores and those undergoing UNT (specifically the submuscular technique) consumed more opioids.

Topics: Acetaminophen; Adult; Age Factors; Aged; Aged, 80 and over; Analgesics, Opioid; Cubital Tunnel Syndrome; Decompression, Surgical; Disability Evaluation; Drug Combinations; Drug Utilization; Humans; Hydrocodone; Insurance, Health; Medicare; Middle Aged; Oxycodone; Pain, Postoperative; Prospective Studies; Ulnar Nerve; United States; Workers' Compensation; Young Adult

Whether for research or quality improvement, assessment of postoperative quality of life outcomes faces a challenge in reliable data collection. Typical coordinator-led studies cite response rates from 35% to 70%. This study evaluates the utility of a digital patient engagement platform to track patient-reported outcome measures (PROMs) following septoplasty and functional endoscopic sinus surgery (FESS).. A prospective cohort was recruited at a tertiary care center from January 2017 to March 2018. A mobile phone application relayed PROMs, including pain (assessed on a 0 to 10 visual analogue scale [VAS] every other day for 2 weeks, as well as the patient-reported outcome measure information system [PROMIS] pain interference short form 4a at baseline, 2 weeks, and 3 months) and timing of return to work.. Of 288 patients enrolled, 249 (86.5%) provided clinical data, including 208 who underwent septoplasty or FESS. Granular VAS scores, submitted by 195 patients, demonstrated 80% of these patients achieved minimal pain by postoperative day 8. A nonsignificant trend of increased days to pain relief by procedure emerged: septoplasty (mean ± standard deviation [SD], 3.60 ± 2.44), FESS (3.96 ± 3.25), FESS with septoplasty (4.40 ± 3.04), and FESS with drilling (4.86 ± 3.68). Across procedures, PROMIS pain interference increased at 2 weeks (9.17 ± 4.15) and decreased at 3 months (5.32 ± 2.61) compared with baseline (7.09 ± 4.63), with greater improvement noted in the FESS subgroup at 3 months. Patients returned to work at mean 7.1 days regardless of procedure.. With its high response rate, mobile digital patient engagement platforms may effectively track postoperative outcomes with the potential for reduced sample bias.

Topics: Acetaminophen; Adult; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Drug Combinations; Endoscopy; Female; Humans; Hydrocodone; Male; Middle Aged; Nasal Surgical Procedures; Pain, Postoperative; Patient Reported Outcome Measures; Prospective Studies; Return to Work; Telemedicine; Visual Analog Scale

Widely-prescribed prodrug opioids (e.g., hydrocodone) require conversion by liver enzyme CYP-2D6 to exert their analgesic effects. The most commonly prescribed antidepressant, selective serotonin reuptake inhibitors (SSRIs), inhibits CYP-2D6 activity and therefore may reduce the effectiveness of prodrug opioids. We used a machine learning approach to identify patients prescribed a combination of SSRIs and prodrug opioids postoperatively and to examine the effect of this combination on postoperative pain control. Using EHR data from an academic medical center, we identified patients receiving surgery over a 9-year period. We developed and validated natural language processing (NLP) algorithms to extract depression-related information (diagnosis, SSRI use, symptoms) from structured and unstructured data elements. The primary outcome was the difference between preoperative pain score and postoperative pain at discharge, 3-week and 8-week time points. We developed computational models to predict the increase or decrease in the postoperative pain across the 3 time points by using the patient's EHR data (e.g. medications, vitals, demographics) captured before surgery. We evaluate the generalizability of the model using 10-fold cross-validation method where the holdout test method is repeated 10 times and mean area-under-the-curve (AUC) is considered as evaluation metrics for the prediction performance. We identified 4,306 surgical patients with symptoms of depression. A total of 14.1% were prescribed both an SSRI and a prodrug opioid, 29.4% were prescribed an SSRI and a non-prodrug opioid, 18.6% were prescribed a prodrug opioid but were not on SSRIs, and 37.5% were prescribed a non-prodrug opioid but were not on SSRIs. Our NLP algorithm identified depression with a F1 score of 0.95 against manual annotation of 300 randomly sampled clinical notes. On average, patients receiving prodrug opioids had lower average pain scores (p<0.05), with the exception of the SSRI+ group at 3-weeks postoperative follow-up. However, SSRI+/Prodrug+ had significantly worse pain control at discharge, 3 and 8-week follow-up (p < .01) compared to SSRI+/Prodrug- patients, whereas there was no difference in pain control among the SSRI- patients by prodrug opioid (p>0.05). The machine learning algorithm accurately predicted the increase or decrease of the discharge, 3-week and 8-week follow-up pain scores when compared to the pre-operative pain score using 10-fold cross validation (mean a

Topics: Adult; Aged; Antidepressive Agents; Depression; Drug Prescriptions; Electronic Health Records; Female; Humans; Hydrocodone; Machine Learning; Male; Middle Aged; Models, Biological; Natural Language Processing; Pain Management; Pain, Postoperative; Postoperative Period; Selective Serotonin Reuptake Inhibitors

The purpose of this study was to evaluate current surgical practice patterns, the factors that influence these patterns, and overall trends in the treatment of thumb carpometacarpal osteoarthritis.. An online survey containing 14 questions was sent to all active members of the American Society for Surgery of the Hand. Information on demographics and treatments was collected. Results were anonymously uploaded to an online spreadsheet.. A total of 823 responses were recorded. Trapeziectomy with ligament reconstruction and tendon interposition (LRTI) using whole flexor carpi radialis was the most popular technique at 37.44%. In all, 26.38% of surgeons with fewer than 5 years of experience utilize trapeziectomy with suture suspension (bone anchor based or tendon based); 55.76% choose a particular procedure because of "Personal Clinical Experience" over "Current Evidence" and "Training." In addition, 24.17% of surgeons who have been practicing for longer than 5 years have changed procedures in the last 5 years. In the United States, 97.2% of hand surgeons prescribe either oxycodone or hydrocodone postoperatively compared with just 23.75% of international hand surgeons.. The results show that trapeziectomy with LRTI remains the most popular treatment of choice. The use of trapeziectomy with suture suspension is on the rise, particularly in younger surgeons. International hand surgeons rely more on current evidence, utilize less postoperative therapy and opioid medications, and change procedures more often than US hand surgeons.

Topics: Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Carpometacarpal Joints; Clinical Competence; Drug Prescriptions; Humans; Hydrocodone; Immobilization; Orthopedic Procedures; Osteoarthritis; Oxycodone; Pain, Postoperative; Postoperative Care; Practice Patterns, Physicians'; Surgeons; Surveys and Questionnaires; Thumb; United States

Topics: Acetaminophen; Aged; Analgesics, Opioid; Cholecystectomy, Laparoscopic; Drug Prescriptions; Evidence-Based Medicine; Female; Humans; Hydrocodone; Ibuprofen; Interrupted Time Series Analysis; Male; Middle Aged; Pain Measurement; Pain, Postoperative; Postoperative Care; Practice Guidelines as Topic; Surveys and Questionnaires

Prescription opioid abuse is an epidemic in the United States; multimodal analgesia has been suggested as a potential solution to decrease postoperative opioid use. The primary aim of this study was to determine the effect of perioperative celecoxib on opioid intake. Secondary goals were to determine whether perioperative administration of celecoxib decreased postoperative patient-reported pain and whether patient demographic characteristics could predict postoperative pain and opioid intake.. This prospective cohort study enrolled patients undergoing mass excision or carpal tunnel, trigger finger, or de Quervain release by 1 of 3 fellowship-trained hand surgeons. Patients in the experimental group were given 200 mg celecoxib tablets taken twice a day starting the day before surgery and continued for 5 days after surgery. Both groups received hydrocodone-acetaminophen tablets 5 mg/325 mg as needed after surgery. After surgery, patients completed daily opioid consumption and pain logs for 7 days and underwent a pill count. Outcomes included morphine milligram equivalents (MME) consumed and postoperative pain.. A total of 123 patients were enrolled: 68 control patients and 54 celecoxib patients. Fifty (74%) and 37 (69%) patients, respectively, completed the study. Overall, the median number of MMEs consumed was 25 (range, 0-330). During the first postoperative week, patients in the celecoxib and control groups were similar with respect to postoperative pain experienced (median visual analog scale score, 2.0 vs 1.4, respectively) and amount of opioid taken (median MMEs = 30 vs 20, respectively).. Patients taking perioperative celecoxib had similar postoperative pain and opioid intake compared with patients not prescribed celecoxib in the study. Regardless of study group, 4 to 10 hydrocodone tablets were sufficient to control postoperative pain for most patients undergoing soft tissue ambulatory hand surgery. This may be the result of the limited duration and mild nature of pain after outpatient elective hand surgery.. Therapeutic II.

Topics: Acetaminophen; Age Factors; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Carpal Tunnel Syndrome; Case-Control Studies; Celecoxib; Cohort Studies; De Quervain Disease; Drug Utilization; Female; Ganglion Cysts; Humans; Hydrocodone; Linear Models; Male; Middle Aged; Pain Threshold; Pain, Postoperative; Perioperative Care; Trigger Finger Disorder; Visual Analog Scale

Multimodal analgesic protocols are increasingly favored over traditional opioid regimens due to decreased adverse side effects and reduced opioid consumption. Concomitant use of selective cyclooxygenase (COX)-2 inhibitor celecoxib and anticonvulsant gabapentin have been proposed to adequately control acute postoperative pain.. To determine efficacy of postoperative pain control using nonopioid pain regimen vs traditional opioids for all aesthetic plastic surgery procedures.. A retrospective chart review was performed on 462 consecutive outpatient plastic surgery procedures by a single surgeon between November 2015 and July 2017. Procedures in the historical control group (n = 275) received traditional postoperative narcotic, hydrocodone-acetaminophen. Patients in the more recent nonopioid study group (n = 187) received a pre-, peri-, and postoperative regimen of celecoxib and gabapentin.. Similar demographic characteristics between the control and study groups were observed: mean age, 39.7 vs 39.5 years; BMI, 24.6 vs 24.4 kg/m2; and ratio of female patients 92.7% vs 92.4%. A significant reduction in rescue analgesia (meperidine 44.6% vs 14.9%, P < 0.001) and antiemetic use (ondansetron 24.2% vs 16.3%, P < 0.05; promethazine 17.0% vs 4.7%, P < 0.001) in postanesthesia recovery unit (PACU) was noted in the nonopioid group compared to the control. The average stay in PACU also decreased in the study group (82 ± 39 min vs 70 ± 22 min, P < 0.001). Both groups reported low numbers of adverse events and need for additional pain prescriptions. These findings were reproducible in the breast subgroup.. This nonopioid regimen is as effective as traditional opioid use for acute postoperative pain control and decreased recovery time for outpatient aesthetic plastic breast surgeries.

Topics: Acetaminophen; Adult; Aged; Analgesics, Opioid; Anticonvulsants; Celecoxib; Cyclooxygenase 2 Inhibitors; Drug Combinations; Drug Therapy, Combination; Female; Gabapentin; Humans; Hydrocodone; Male; Middle Aged; Pain Management; Pain Measurement; Pain, Postoperative; Perioperative Care; Plastic Surgery Procedures; Retrospective Studies; Treatment Outcome; Young Adult

In 2014, hydrocodone was moved from Schedule III to II, thus it could no longer be "called in" to a pharmacy. We analyzed current postoperative opioid prescribing patterns and the impact of the schedule change on the type and amount prescribed.. Opioid prescriptions for common surgeries at 1 medical center from 2013 to 2016 were analyzed retrospectively. Milligram morphine equivalents prescribed before and after the schedule change were compared by t tests, and interrupted time series models and drug frequencies were compared by χ. Data from 7,046 patients (7,361 prescriptions) after 29 different operations were analyzed. Milligram morphine equivalents prescribed for minor open procedures ranged from 211 to 342 milligram morphine equivalents, from 323 to 1297 for major open procedures, from 238 to 359 for basic laparoscopic procedures, and from 221 to 868 for complex laparoscopic procedures. Mean milligram morphine equivalents prescribed were not affected for most procedures, but over the entire population, milligram morphine equivalents prescribed began decreasing after the rule change. The percentage of hydrocodone prescriptions decreased after the rule change (from 33.8% down to 27.0%) and oxycodone and tramadol prescriptions increased.. Before versus after the rule change, hydrocodone prescriptions decreased and oxycodone and tramadol prescriptions increased. Milligram morphine equivalents prescribed varied considerably across and within classes of procedures, but the schedule change did not affect mean milligram morphine equivalents prescribed for most procedures.

Topics: Analgesics, Opioid; Drug Administration Schedule; Humans; Hydrocodone; Pain, Postoperative; Postoperative Period; Practice Patterns, Physicians'; Retrospective Studies; United States

In 2014, the US Drug Enforcement Administration moved hydrocodone-containing analgesics from schedule III to the more restrictive schedule II to limit prescribing and decrease nonmedical opioid use. The association of this policy change with postoperative prescribing is not well understood.. To examine the hypothesis that the amount of opioids prescribed following surgery is associated with the rescheduling of hydrocodone.. An interrupted time series analysis of outpatient opioid prescriptions was conducted to examine the trends in the amount of postoperative opioids filled before and after the schedule change. Opioid prescriptions filled between January 2012 and October 2015 were analyzed using insurance claims data from the Michigan Value Collaborative, which includes data from 75 hospitals across Michigan. A total of 21 955 adult inpatients 18 to 64 years of age who underwent 1 of 19 common elective surgical procedures and filled an opioid prescription within 14 days of discharge to home were eligible for inclusion.. The primary outcome was the trends in the mean amount of opioids filled in oral morphine equivalents (OMEs) for the initial postoperative prescriptions before and after the schedule change date of October 6, 2014, compared using interrupted time series and multivariable regression analyses. Secondary outcomes included the total amount of opioids filled and the refill rate for the 30-day postoperative period. Subgroup analyses were performed by hydrocodone prescriptions, nonhydrocodone prescriptions, surgical procedure, and prior opioid use.. Data from 21 955 patients undergoing surgical procedures across 75 hospitals and 5120 prescribers were analyzed. Cohorts before and after the schedule change were equivalent with respect to sex (10 197 of 15 791 [64.6%] vs 3966 of 6169 [64.3%] female; P = .69) and mean (SE) age (47.9 [11.2] vs 47.7 [11.3] years; P = .19). After the schedule change, the mean OMEs filled in the initial opioid prescription increased by approximately 35 OMEs (β = 35.1 [13.2]; P < .01), equivalent to 7 tablets of hydrocodone (5 mg). There were no significant differences in the total OMEs filled during the 30-day postoperative period before and after the schedule change (β = 18.3 [30.5]; P = .55), but there was a significant decrease in the refill rate (β = -5.2% [1.3%]; P < .001).. Changing hydrocodone from schedule III to schedule II was associated with an increase in the amount of opioids filled in the initial prescription following surgery. Opioid-related policies require close follow-up to identify and address early unintended effects given the multitude of competing factors that influence health care professional prescribing behaviors.

Topics: Adolescent; Adult; Aged; Analgesics, Opioid; Drug Administration Schedule; Drug Prescriptions; Female; Humans; Hydrocodone; Interrupted Time Series Analysis; Male; Middle Aged; Pain, Postoperative; Practice Patterns, Physicians'; Prescription Drug Diversion; Regression Analysis; Retrospective Studies; Young Adult

Opioids are an effective, and often necessary, treatment of postoperative pain after total knee arthroplasty (TKA). However, it is often difficult to know how much medication patients will need after discharge. The purpose of this study was to determine if patients discharged with greater quantities of opioids after TKA are more likely to request refills.. This is a retrospective review of 105 primary TKAs performed with at least 1 year of follow-up. Exclusion criteria included bilateral TKA, preoperative opioid use, or reoperation within the first 3 months. Data collected included opioid refills, Knee Society Score, and total and daily morphine equivalent dose (MED) prescribed.. Patients were most commonly discharged on oxycodone (90%), hydromorphone (5%), and hydrocodone/acetaminophen (1%). The average total prescribed MED was 1405 ± 616 mg (range, 273-3250 mg). Patients requiring refills did not differ in the total prescribed MED (1521 ± 624 vs 1349 ± 609 mg; P = .1), daily prescribed MED (153 ± 10 vs 155 ± 7 mg; P = .8), or preoperative Knee Society Score (63 ± 16 vs 60 ± 13; P = .3). Average follow-up time was 2.4 ± 0.5 years.. The quantity of opioids prescribed after TKA varied widely, ranging from a total MED of 273-3250 mg. The refill rate did not differ between large prescriptions (≥1400 mg) and smaller prescriptions. Excessive opioid prescriptions should be avoided as they did not decrease the number of refills and pose the risk of divergence and subsequent abuse.

Topics: Acetaminophen; Aged; Aged, 80 and over; Analgesics, Opioid; Arthroplasty, Replacement, Knee; Drug Combinations; Drug Prescriptions; Female; Follow-Up Studies; Humans; Hydrocodone; Hydromorphone; Knee Joint; Male; Middle Aged; Morphine; Opioid-Related Disorders; Oxycodone; Pain, Postoperative; Patient Discharge; Reoperation; Retrospective Studies

We attempted to describe the opioid prescribing patterns for ambulatory pediatric surgery in the United States from 2007 to 2014.. Retrospective database review.. Operating room ambulatory encounters as determined by the Truven Health Marketscan Commercial Claims and Encounters database.. A total of 929,874 ambulatory surgical encounters were identified in patients <18years of age and, of these, 439,286 encounters generated an analgesic prescription.. N/A MEASUREMENTS: The analgesic prescription was described in terms of the type of opioid along with the inclusion of acetaminophen and/or NSAIDs.. The probability of receiving a post-operative analgesic prescription increased with age, ranging from 18.2% of infants to 71.7% of teens. Acetaminophen with codeine (APAP/C) was the most common drug for infants (63.8%), while acetaminophen with hydrocodone (APAP/H) was the most common analgesic prescription for teens (53.6%). APAP/C and APAP/H were the predominant drugs used for all procedure types.. Substantial variability in analgesic prescribing at the level of the procedure performed, both in terms of the probability of receiving a prescription and in which drugs were prescribed. We observed significant age and procedure-based variability in opioid prescribing following pediatric ambulatory surgery.

Topics: Acetaminophen; Adolescent; Ambulatory Surgical Procedures; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Child; Child, Preschool; Codeine; Drug Combinations; Drug Prescriptions; Humans; Hydrocodone; Infant; Male; Pain Management; Pain, Postoperative; Pediatricians; Professional Practice; Retrospective Studies; United States

Topics: Acetaminophen; Analgesics, Opioid; Drug Combinations; Drug Prescriptions; Humans; Hydrocodone; Molar, Third; Pain, Postoperative; Practice Patterns, Dentists'; Tooth Extraction; Tooth, Impacted

This article evaluates postoperative analgesia in pediatric palatoplasty patients using nonopioid oral medications.. This study was a retrospective chart review.. The setting for this study was a tertiary-care children's hospital.. Study participants were pediatric patients who underwent palatoplasty procedures performed by a single surgeon.. Interventions included nonopioid and opioid oral medications for postoperative analgesia.. The adequacy of nonopioid versus opioid oral analgesia was assessed by (1) time to discontinue IV fluid, (2) total IV morphine doses for breakthrough pain, (3) daily IV morphine doses for breakthrough pain, (4) time to discharge from the hospital, and (5) perioperative weight change. Group comparisons of outcome measures were performed using a two one-sided test.. A total of 61 patients were identified who received three standard pain regimens: acetaminophen + ibuprofen (12), hydrocodone/acetaminophen (23), and hydrocodone/acetaminophen + ibuprofen (26). There was sufficient evidence to suggest equivalence in outcome measures for acetaminophen + ibuprofen versus hydrocodone/acetaminophen and hydrocodone/acetaminophen + ibuprofen for the following: time to discontinue IV fluid (P = .02, 90% confidence interval [CI] = -0.42 to 0.17; P = .007, 90% CI = -0.28 to 0.34), daily IV morphine doses (P = .023, 90% CI = -0.83 to 0.65; P = .032, 90% CI = -0.92 to 0.28), time to discharge from the hospital (P = .017, 90% CI = -0.40 to 0.27; P = .015, 90% CI = -0.24 to 0.39), and perioperative weight change (P = .002; 90% CI = -0.25 to 0.46; P < .0001; 90% CI = -0.34 to 0.18). There was no sufficient evidence to suggest equivalence for total IV morphine doses (P = .189, 90% CI = -1.51 to 1.78; P = .169, 90% CI = -1.51 to 0.88).. Oral acetaminophen and ibuprofen alone may provide similar analgesia to traditional regimens with reduced risks following pediatric palatoplasty.

Topics: Acetaminophen; Administration, Oral; Analgesics, Non-Narcotic; Analgesics, Opioid; Drug Combinations; Female; Humans; Hydrocodone; Ibuprofen; Infant; Male; Morphine; Pain Management; Pain, Postoperative; Palate; Retrospective Studies

Opioids are frequently used for treatment of moderate to severe short-term pain, but concerns exist about this treatment approach. Ketorolac tromethamine nasal spray, a nonsteroidal anti-inflammatory, is indicated for the short-term management of moderate to moderately severe pain requiring analgesia at the opioid level. However, there are no direct comparison studies between ketorolac nasal spray and opioids. The objective of this study was to use an effect size analysis to compare the effectiveness of ketorolac nasal spray with oral combination opioid formulations in treating moderate to severe short-term pain.. An effect size analysis of three randomized, double-blind, placebo-controlled studies of third molar extraction surgery compared pain relief with ketorolac nasal spray and commonly prescribed combination opioids including hydrocodone/acetaminophen (APAP), oxycodone/APAP, oxycodone/ibuprofen and tramadol HCl/APAP. Effect size comparisons were made using total pain relief scores (TOTPAR6 or TOTPAR8; the weighted sum of pain relief scores through 6 or 8 h). Pain relief was measured using a five-point categorical rating scale (0 = none; 4 = complete). The effect size equivalent correlation, r, was determined using an online effect size calculator. The treatment effect size r compared with placebo was classified using established criteria (small = 0.20-0.49, moderate = 0.50-0.79 and large = ≥ 0.80).. TOTPAR6 data indicated a moderate effect size for ketorolac nasal spray 31.5 mg (0.51) and oxycodone/ibuprofen 5/400 mg (0.64) and a small effect size for hydrocodone/APAP 7.5/500 mg (0.24) and oxycodone/APAP 5/325 mg (0.32). TOTPAR8 data indicated small effect sizes for ketorolac nasal spray (0.48), hydrocodone/APAP 10/650 mg (0.43), tramadol HCl/APAP 75/650 mg (0.35) and tramadol HCl/APAP 37.5/325 mg (0.17).. The treatment effect sizes of ketorolac nasal spray were similar to or higher than the opioid comparators after third molar surgery, a well-accepted pain model. These results support ketorolac nasal spray as an effective treatment for moderate to moderately severe short-term pain.

Topics: Acetaminophen; Administration, Oral; Adolescent; Adult; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Drug Combinations; Female; Humans; Hydrocodone; Ibuprofen; Ketorolac; Male; Molar, Third; Nasal Sprays; Oxycodone; Pain Measurement; Pain, Postoperative; Randomized Controlled Trials as Topic; Tooth Extraction; Tramadol; Treatment Outcome; Young Adult

Topics: Acetaminophen; Adult; Age Factors; Analgesics, Opioid; Arthroscopy; Carpal Tunnel Syndrome; Cholecystectomy, Laparoscopic; Drug Prescriptions; Hernia, Inguinal; Humans; Hydrocodone; Knee Joint; Middle Aged; Oxycodone; Pain, Postoperative; Risk; Sex Factors; Surgical Procedures, Operative; United States; Young Adult

Topics: Analgesics, Opioid; Drug Therapy, Combination; Humans; Hydrocodone; Pain Management; Pain, Postoperative

Genetic variations in enzymes that produce active metabolites from pro-drugs are well known. Such variability could account for some of the clinically observed differences in analgesia and side effects seen in postoperative patients. Using genotyping and quantitation of serum concentrations of hydrocodone and its metabolites, we sought to demonstrate the clinical effects of the metabolites of hydrocodone on pain relief. The objective of the current study was to determine whether CYP2D6 genotype and serum hydromorphone levels account for some of the variability in pain relief seen with hydrocodone in a cohort of women post-Cesarean section.. In 156 post-Cesarean section patients who received hydrocodone, we assessed serum opioid concentrations and CYP2D6 genotypes. Blood samples were collected at that time for genotyping and determination of concentrations of hydrocodone and metabolites by LC-MS/MS. Multivariate analysis was used to determine the relationship between CYP2D6 genotypes, pain relief, side effects, and serum concentrations of hydrocodone and hydromorphone.. The CYP2D6 genotyping results indicated that 60% of subjects were extensive, 30% intermediate, 3% poor, and 7% ultra-rapid metabolizers. In the poor metabolizers, the mean plasma hydromorphone concentration was 8-fold lower when compared to that of ultra-rapid metabolizers. Hydromorphone, and not hydrocodone concentrations correlated with pain relief.. This study shows that hydromorphone is generated at substantially different rates, dependent on CYP2D6 genotype. Pain relief correlated with plasma concentrations of hydromorphone, and not with hydrocodone. This suggests that pain relief will vary with CYP2D6 genotype. Inability to metabolize hydrocodone to hydromorphone as seen in the poor metabolizers should alert the clinician to consider alternative medications for managing pain postoperatively.

Topics: Adolescent; Adult; Cytochrome P-450 CYP2D6; Female; Genotype; Humans; Hydrocodone; Middle Aged; Pain Management; Pain, Postoperative; Precision Medicine; Prodrugs; Young Adult

Little is known about postoperative opioid prescribing patterns among dermatologic surgeons.. To better understand postoperative opioid prescribing patterns among dermatologic surgeons in the United States.. Two-part analysis consisting of a retrospective chart review of 233 dermatologic surgery patients at a single institution and an e-mail survey of American Society for Dermatologic Surgery (ASDS) members.. (1) Retrospective review: 35% (82/233) of the patients received an opioid prescription. Larger defect size, repair of the defect, perioral and nasal site, and surgeon A or B performing surgery predicted opioid prescription. (2) E-mail survey: 556 ASDS members practicing within the United States responded. Sixty-four percent (357/556) reported prescribing opioids after ≤10% of cases. Surgeons younger than 55 years old, male surgeons, and surgeons in the southern and western United States were more likely to prescribe opioids after >10% of cases. Seventy-six percent (397/520) believed patients used ≤50% of the opioid pills prescribed.. The retrospective review suggests that opioid prescribing is predicted by characteristics of the surgery (i.e., size, defect repair type, and anatomic location) and characteristics of the surgeon (i.e., age, sex, and practice location) with significant heterogeneity in prescribing habits. The national survey results raise the possibility that patients might not take all prescribed opioid pills after dermatologic surgery. Further investigation is warranted to determine how patients are actually using prescription pain pills to balance pain control with patient safety.

Topics: Acetaminophen; Age Factors; Aged; Aged, 80 and over; Analgesics, Opioid; Carcinoma, Basal Cell; Carcinoma, Squamous Cell; Codeine; Drug Combinations; Facial Neoplasms; Female; Health Care Surveys; Humans; Hydrocodone; Male; Melanoma; Middle Aged; Mohs Surgery; Oxycodone; Pain, Postoperative; Practice Patterns, Physicians'; Professional Practice Location; Retrospective Studies; Sex Factors; Skin Neoplasms; Societies, Medical; United States

Clinicians are now appreciating that the perception of pain is a multifaceted, biopsychosocial construct. Expectation of postsurgical pain is part of this construct and should be considered preoperatively. It is our belief that by establishing reasonable expectations with preoperative teaching, we can minimize narcotic use and lessen untoward issues that can potentially follow. With this goal in mind, we have been using a comprehensive pre- and postoperative program for our outpatient orthopedic surgery patients for the last 5 years, which includes physical, pharmacologic, and simple sport psychological techniques.. We reviewed postoperative prescription narcotic purchases in 133 consecutive surgical patients during the last year (2013). All patients were given a prescription postoperatively for 10 hydrocodone 5-mg/acetaminophen 500-mg tablets, with 1 refill. We then contacted the patients' pharmacies to assess the actual amount purchased.. Data were available for 100 patients. Of these, 62 patients had undergone "simple" arthroscopies and 38 had had "open" procedures, including 25 anterior cruciate ligament reconstructions, 4 tibial tubercle osteotomies, and various other surgeries. Of the 62 arthroscopies, 24 patients (39%) refilled their prescriptions, with 4 patients (6%) needing > 1 refill. Of the 38 open procedures, 16 patients (42%) refilled their medications, 2 (5%), more than once. Thus, 89% of patients required ≤ 20 narcotic tablets after undergoing common orthopedic operations. No patient needed chronic narcotic medication.. Pain is a complex issue and patient expectation of postoperative pain is one aspect that can potentially affect the amount of narcotics used. By preparing the patient both physically and psychologically, we believe the amount of narcotics used postoperatively can be decreased without affecting pain control. As a result, the multiple possible detriments of having more narcotics available than actually necessary would be lessened. By limiting the overall number of narcotic tablets prescribed, decreased use by the patient when such a medication may no longer be appropriate, and minimized use by others in the household who might have access to it would decrease.

Topics: Acetaminophen; Adolescent; Adult; Aged; Analgesics, Opioid; Arthroscopy; Drug Combinations; Female; Humans; Hydrocodone; Male; Middle Aged; Orthopedic Procedures; Pain, Postoperative; Practice Patterns, Physicians'; Retrospective Studies; Tablets; Young Adult

Topics: Acetaminophen; Analgesics, Opioid; Anesthetics, Local; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Epinephrine; Glucocorticoids; Humans; Hydrocodone; Lidocaine; Male; Molar, Third; Nociceptors; Pain Perception; Pain, Postoperative; Tooth Extraction; Tooth, Impacted; Vasoconstrictor Agents; Young Adult

It has been suggested that a source of narcotics used for nonmedical purposes by young adults is the unused opioids prescribed for the management of pain after the removal of impacted third molars. The purpose of the present study was to determine whether oral and maxillofacial surgeons routinely prescribe larger amounts of a narcotic than would generally be needed for adequate postoperative pain control. A secondary goal was to determine whether they use methods other than analgesic drugs to minimize postoperative pain and thereby reduce the amount of narcotic that might be needed.. An 8-question survey was sent to 100 randomly selected oral and maxillofacial surgeon members of the American Association of Oral and Maxillofacial Surgeons in each of the 6 association districts. The questions asked were related to whether a narcotic was routinely prescribed for patients who have had impacted teeth removed, the most common drug used, and the dosage and number of tablets prescribed. The participants were also asked whether they had pretreated patients with a nonsteroidal anti-inflammatory drug or had prescribed one along with the narcotic, had injected a steroid, or had used a long-lasting local anesthetic postoperatively.. Only 2 of the 384 respondents stated that they did not prescribe a narcotic for patients who had had impacted teeth removed. Hydrocodone (5 mg) was the most frequently prescribed narcotic. The number of tablets varied from 10 to 40, but the most common number was 20 tablets. However, 80 respondents (22%) prescribed more, with 40 prescribing 30 tablets. Also, 80% of the respondents injected their patients with a steroid, and 62% injected a long-lasting local anesthetic postoperatively. Only 34% pretreated their patients with a nonsteroidal anti-inflammatory drug, but 66% recommended such use postoperatively.. Most oral and maxillofacial surgeons prescribe analgesic drugs of an appropriate type and dosage and use proper adjunctive pain control measures to supplement these drugs. However, our findings also indicated that more than 20% prescribe more tablets than would generally be necessary to control the postoperative pain after the removal of impacted third molars. This could be a source of drug diversion and nonmedical use by young adults and should be avoided.

Topics: Anesthetics, Local; Anti-Inflammatory Agents, Non-Steroidal; Attitude of Health Personnel; Humans; Hydrocodone; Injections; Molar, Third; Narcotics; Oxycodone; Pain, Postoperative; Practice Patterns, Dentists'; Premedication; Prescription Drugs; Steroids; Surgery, Oral; Tooth Extraction; Tooth, Impacted

Laparoscopic appendectomy is a common emergency pediatric surgery procedure accompanied by substantial pain (pain scores >4 for >60% of the time) in 33% of these patients. We introduced a bundle of pain management interventions including local anesthetic infiltration at the incision site, intravenous (IV) opioids by patient-controlled analgesia (PCA), and scheduled doses of IV ketorolac and oral acetaminophen/hydrocodone.. To evaluate the effect of these pain management interventions on pain control after laparoscopic appendectomy.. We retrospectively studied pain in 206 children above 7 years of age undergoing laparoscopic appendectomy from December 2011 to February 2012 at our institution. We extracted data on patient demographics, duration of anesthesia and surgery, intraoperative opioids, local anesthetic infiltration, surgical procedure reports, along with pain scores, postoperative PCA use, and opioid-related complications and hospital stays. Patients were divided into two groups - simple appendicitis without peritonitis and appendicitis with generalized peritonitis.. The incidence of substantial pain when the multimodal regimen was used was 12%, which is significantly lower than earlier reports (Fisher's exact test P < 0.001). Patients with generalized peritonitis experienced more pain, consumed more opioids, had more unmet PCA demands, and a higher incidence of respiratory depression compared with those with simple appendicitis.. The multimodal regimen of local anesthetic infiltration, opioid by PCA, NSAIDs, and oral acetaminophen/hydrocodone reduced the incidence of substantial pain. Additional studies are required to identify subgroups of patients with minimal opioid requirements who can benefit from modifications of this regimen.

Topics: Acetaminophen; Adolescent; Analgesia, Patient-Controlled; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Appendectomy; Appendicitis; Child; Female; Humans; Hydrocodone; Laparoscopy; Length of Stay; Male; Morphine; Pain Management; Pain Measurement; Pain, Postoperative; Peritonitis; Postoperative Complications; Retrospective Studies; Treatment Outcome

After elective outpatient upper extremity surgery, patients' need for opioid analgesic medication may be considerably less than typically dispensed. Our goal for this study was to evaluate pain control and quantify the amount of leftover pain medication.. We recruited patients scheduled for elective outpatient upper extremity surgery, who met the inclusion criteria, to participate in a phone interview 7 to 14 days after surgery. Information collected included age, gender, procedure performed, analgesic medication and regimen prescribed, satisfaction with pain control, number of tablets remaining, reasons for not taking medication, other analgesic medications used, payer classification, and any adverse drug reactions.. A total of 287 eligible subjects consented to participate. Of these, 36 patients failed phone contact and 1 patient canceled surgery, which left 250 patients who completed the study. Oxycodone, hydrocodone, and propoxyphene accounted for over 95% of the prescription medications, with adequate pain control reported by 230 (92%) patients. Patients most frequently received 30 pills. Patients undergoing bone procedures reported the highest medication use (14 pills), whereas patients undergoing soft tissue procedures reported the lowest use (9 pills). Over half of the subjects reported taking the opioid medication for 2 days or less. Medicare patients consumed significantly less medication (7 pills, P < .05) than patients covered by all other types of insurance. Overall, patients consumed a mean of 10 opioid pills, whereas 19 pills per subject were reported unused, which resulted in 4,639 leftover tablets for the entire cohort.. Our data show that excess opioid analgesics are made available after elective upper extremity surgery and could potentially become a source for diversion. A prescription of 30 opioid pills for outpatient surgery appears excessive and unnecessary, especially for soft tissue procedures of the hand and wrist.. Prognostic I.

Topics: Aged; Aged, 80 and over; Ambulatory Surgical Procedures; Analgesics, Opioid; Dextropropoxyphene; Drug Utilization; Female; Hand; Humans; Hydrocodone; Middle Aged; Oxycodone; Pain, Postoperative; Patient Satisfaction; Practice Patterns, Physicians'; Young Adult

Recent case reports have alerted the medical community of fatality in children receiving codeine after tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome.. The objective of this study was to compare the rates of oxygen desaturation before and after adenotonsillectomy in children with obstructive sleep apnea syndrome (OSAS), and to examine the relationship between cytochrome P450 2D6 (CYP2D6) genotype and respiratory events.. This was a prospective observational study.. Twenty-six children with OSAS (mean age 78 months, range 1.8-17 years) who underwent adenotonsillectomy were studied. CYP2D6 genotype was characterized in 21 of these children. The primary endpoints of the study were the change in the rate of desaturation and in the nadir oxygen saturation values before and in the first 24 hours after surgery as measured by pulse oximetry.. Twenty-two children received codeine and four were managed with hydrocodone. There was no post-operative improvement in the mean rate of desaturation (1.84 ± 1.45/hour pre-operative vs 2.97 ± 3.3/hour post-operative; p = 0.119; 95% CI -2.56, 0.313), or the post-operative nadir of oxygen saturation (85.2 ± 5.8% pre-operative vs 84.0 ± 6.8% post-operative; p = 0.632; 95% CI -3.00, 4.84) on the night after surgery. Prior to surgery, six children had an oxygen saturation nadir <80%, while post-surgery, the number increased to eight children. Ten children improved their parameters after surgery. CYP2D6 genotype by itself did not predict the changes in desaturation or nadir.. Post-operative use of opioids following OSAS may not be safe for all children. It is conceivable that if the child is among the significant proportion that experiences increased oxygen desaturations, the CNS depressing effects of codeine or hydrocodone and their respectively potent morphine or hydromorphone metabolites can further compromise respiratory drive. Larger studies are needed to investigate the potential contribution of CYP2D6 genotype.

Topics: Adenoidectomy; Adolescent; Analgesics, Opioid; Child; Child, Preschool; Codeine; Cytochrome P-450 CYP2D6; Female; Genotype; Humans; Hydrocodone; Infant; Male; Oximetry; Oxygen; Pain, Postoperative; Pilot Projects; Polysomnography; Prospective Studies; Sleep Apnea, Obstructive; Tonsillectomy

Addictive behavior following gastric bypass surgery is widely discussed in the lay press, but published reports provide conflicting evidence regarding the prevalence of postoperative substance abuse among bariatric surgery patients. We present a case report of a Roux-en-Y gastric bypass patient who presented with recurrent and various pain and nausea complaints postoperatively. These symptoms resulted in multiple radiological and operative procedures before her narcotic addiction was identified. Physicians caring for bariatric surgical patients postoperatively need to be aware of this risk and need to be able to identify early signs of potential postoperative addictions.

Topics: Abdominal Pain; Adult; Feeding Behavior; Female; Flank Pain; Gastric Bypass; Humans; Hydrocodone; Laparotomy; Obesity, Morbid; Opioid-Related Disorders; Pain, Postoperative; Postoperative Period

Topics: Acetaminophen; Adenoidectomy; Analgesics, Non-Narcotic; Analgesics, Opioid; Child; Humans; Hydrocodone; Pain, Postoperative; Postoperative Nausea and Vomiting; Randomized Controlled Trials as Topic; Research Design; Selection Bias; Sleep Apnea, Obstructive; Tonsillectomy

Prescription narcotic abuse is a significant social problem. Surplus medication following surgery is 1 source of prescription diversion. We assessed prescribing practices, consumption and disposal of prescribed narcotics after urological surgery.. Surveys were administered to a 3-month consecutive sample of adult patients who underwent surgery performed by full and adjunct University of Utah Urology faculty. Surveys were performed 2 to 4 weeks postoperatively. With the exception of the investigators, prescribing physicians had no prior knowledge of the study. Data collected included perception of pain control, type and quantity of medication prescribed, quantity of leftover medication, refills needed, disposal instructions and surplus medication disposition.. Overall 47% of 586 patients participated in the study. Hydrocodone was prescribed most commonly (63%), followed by oxycodone (35%), and 86% of the patients were satisfied with pain control. Of the dispensed narcotics 58% was consumed and 12% of patients requested refills. A total of 67% of patients had surplus medication from the initial prescription and 92% received no disposal instructions for surplus medication. Of those patients with leftover medication 91% kept the medication at home while 6% threw it in the trash, 2% flushed it down the toilet and less than 1% returned it to a pharmacy.. Overprescription of narcotics is common and retained surplus medication presents a readily available source of opioid diversion. It appears that no entity on the prescribing or dispensing ends of prescription opioid delivery is fulfilling the responsibility to accurately educate patients on proper surplus medication disposal. Surgeons should analyze prescribing practices and consider decreasing the quantity of postoperative narcotics prescribed.

Topics: Adult; Analgesics; Analgesics, Opioid; Cross-Sectional Studies; Drug Prescriptions; Drug Utilization; Drug Utilization Review; Female; Humans; Hydrocodone; Male; Middle Aged; Needs Assessment; Opioid-Related Disorders; Oxycodone; Pain, Postoperative; Population Surveillance; Postoperative Care; Practice Patterns, Physicians'; Risk Assessment; Severity of Illness Index; Surveys and Questionnaires; Urologic Surgical Procedures; Urology; Utah

Effective acute pain management is an essential but sometimes challenging component of dental practice. Numerous studies have examined the efficacy of various analgesic agents in dental postoperative models. This article combines an evaluation of the available evidence with current prescribing patterns to provide dental practitioners prescribing recommendations for acute pain, based on the anticipated severity of post-procedural pain. An important consideration when prescribing analgesics is to determine for whom opioid analgesics are necessary and appropriate, and if so, the dose and quantity that should be prescribed. This is partly because of the prevalence of substance and alcohol abuse that can be expected to be encountered within the dental patient population, and because substance abusers in the community frequently obtain prescription drugs from friends and family for misuse.

Topics: Acetaminophen; Acute Disease; Analgesics; Anesthetics, Local; Anti-Inflammatory Agents, Non-Steroidal; Chemical and Drug Induced Liver Injury; Drug Prescriptions; Facial Pain; Humans; Hydrocodone; Opioid-Related Disorders; Oral Surgical Procedures; Pain, Postoperative

This article describes two patients with major ischemic stroke symptoms who had extremely small areas of acute brain infarction, suggestive of acute intrahemispheric diaschisis. Both patients were using narcotic analgesics during their stroke, and in both cases the clinical deficits improved dramatically with naloxone.. We postulate that the narcotics amplified the ischemic stroke symptoms and that this effect was antagonized by naloxone.. This suggests that the opiate system may be involved in the process of intrahemispheric diaschisis.

Topics: Acute Disease; Aged; Brain Ischemia; Female; Humans; Hydrocodone; Hydromorphone; Male; Naloxone; Narcotic Antagonists; Narcotics; Pain, Postoperative

To determine if a minimally invasive approach to lumbar microdiscectomy reduces post-operative pain, length of hospital stay, or frequency of complications we retrospectively compared medical records of single level microdiscectomy patients by a single surgeon performed using a traditional open approach versus a minimally invasive approach. Thirty-five patients were in the open group: 63% male, average age 41.2 years, and 31 patients were in the minimally invasive group: 68% male, average age 42.1 years. There was no difference in surgical time or blood loss between the open and minimally invasive groups: 84.1 versus 76.8 minutes and 51.4 versus 69.7 mL, respectively. There were no significant complications intraoperatively or within the 30 day post-op period for either group. The average dose of intravenous morphine taken was 12.9 mg for the minimally invasive group and 15.7 mg for the open group (P=0.04). The average dose of hydrocodone was 13.4 mg for the minimally invasive group and 20.9 mg for the open group (P=0.03). The open group took an average of 11.7 mg oxycodone, the minimally invasive none. 45.2% of patients in the minimally invasive group were discharged on the same day as surgery compared to 5.75% in the open group (P=0.001). Microdiscectomy was performed safely and effectively through a minimally invasive expanding retractor system and operating microscope. Surgical times, blood loss, complications, and outcome were similar to a traditional open microdiscectomy while pain medication requirements and hospitalization were significantly less.

Topics: Adult; Analgesics, Opioid; Diskectomy; Female; Humans; Hydrocodone; Intervertebral Disc; Intervertebral Disc Displacement; Length of Stay; Lumbar Vertebrae; Male; Microsurgery; Minimally Invasive Surgical Procedures; Oxycodone; Pain, Postoperative; Postoperative Complications; Retrospective Studies; Surgical Instruments; Time Factors; Treatment Outcome

When opioids are used for postoperative pain control, it is useful to define the dose-response relationship for analgesia and respiratory depression. We studied 20 chronically opioid-consuming patients having elective multilevel spine fusion. Preoperatively, each patient received a fentanyl infusion of 2 microg x kg(-1) x min(-1) until the respiratory rate was <5 breaths/min. Pharmacokinetic simulations were used to estimate the effect site concentration at the time of respiratory depression and to predict the patient-controlled analgesia settings that would provide an effect-site fentanyl concentration that was 30% of the concentration associated with respiratory depression. Postoperatively, patient-controlled analgesia settings were adjusted to achieve 2-3 demand doses per hour. At steady-state patient-controlled analgesia settings, arterial blood gases and plasma fentanyl levels were measured. Sixteen patients required no adjustment or one patient-controlled analgesia adjustment. The median arterial Pco(2) level was 41 mm Hg and the interquartile range was 39-46 mm Hg. Plasma fentanyl levels demonstrated a significant correlation to the estimated effect-site concentration associated with respiratory depression determined during the preoperative fentanyl challenge. A preoperative fentanyl challenge used with pharmacokinetic simulations may be a useful tool to individualize the administration of analgesics to chronically opioid-consuming patients.. In chronically opioid-consuming patients, doses causing respiratory depression and analgesia may differ from those in opioid-naive individuals. A preoperative infusion of fentanyl, used in conjunction with pharmacokinetic simulation, may be a valuable tool for identifying clinical end-points, such as respiratory depression and analgesia, and individualizing postoperative treatment of pain in patients who chronically consume opioids.

Topics: Analgesics, Opioid; Blood Gas Analysis; Computer Simulation; Dose-Response Relationship, Drug; Female; Fentanyl; Humans; Hydrocodone; Infusions, Intravenous; Male; Middle Aged; Morphine; Opioid-Related Disorders; Oxycodone; Pain, Postoperative; Preoperative Care; Prospective Studies; Spinal Fusion

This study compared pain and its management in four groups of patients after anterior cruciate ligament (ACL) surgery. Group 1 consisted of primary ACL reconstruction, group 2 primary ACL reconstruction with meniscal repair, group 3 primary ACL reconstruction with meniscal resection, and group 4 revision ACL reconstruction with patellar tendon allograft. Each patient was instructed to record his or her pain level on a visual analog pain scale (VAS) prior to the procedure and for 7 days postoperatively. All patients received a prescribed narcotic to be taken orally as needed every 4-6 hours. Each patient was instructed to taper its use and supplement with non-narcotic as symptoms allowed. The VAS score for all groups peaked at postoperative day 1 and remained elevated at postoperative day 2. At postoperative day 7, the VAS scores for groups 1, 2, and 3 began to show signs of further decline, whereas group 4 persisted at postoperative day 5 levels. A general trend of decreasing narcotic use over time and increasing non-narcotic use was noted in each group; however, these findings were not statistically significant. All four groups had nearly identical mean VAS scores and corresponding narcotic use for each postoperative day despite the differing levels of complexity of surgical intervention in each group.

Topics: Adult; Ambulatory Surgical Procedures; Analgesics, Opioid; Anterior Cruciate Ligament; Anti-Inflammatory Agents, Non-Steroidal; Case-Control Studies; Cryotherapy; Female; Humans; Hydrocodone; Male; Menisci, Tibial; Pain Measurement; Pain, Postoperative; Tendons

Topics: Analgesics, Opioid; Humans; Hydrocodone; Pain, Postoperative; Physician Impairment; Substance-Related Disorders

Increasingly larger series of laparoscopic fundoplications (LF) are being reported. A well-documented advantage of the laparoscopic approach is shortened hospital stay. Most centers report typical lengths of stay (LOS) for LF of 2-3 days. Our success with LF with a LOS of 1 day led to an attempt at performing LF on an ambulatory basis.. Sixty-one consecutive patients with appropriate criteria for LF underwent surgery at our institution. Patients were counseled by the authors as to the usual postop course and progression of diet. All patients received preemptive analgesia (PEA) consisting of perioperative ketorolac and preincisional local infiltration with bupivicaine. Anesthetic management included induction with propofol, high-dose inhalational anesthetics, minimizing administration of parenteral narcotics, and avoidance of reversal of neuromuscular blockade. Immediate postop pain management included parenteral ketorolac and oral hydro- or oxycodone. All patients were given oral fluids and soft solids after transfer from the recovery room to the postoperative observation unit. Two patients were excluded from ambulatory consideration due to excessive driving distance from our hospital. Another two were hospitalized for observation after experiencing intraoperative technical problems.. Of 57 patients in whom same-day discharge was attempted, there were three failures requiring overnight hospitalization: All were due to pain and nausea; one patient also suffered transient urinary retention. There were no adverse outcomes related to early discharge, and there were no readmissions. One patient returned to the emergency room after delayed development of urinary retention. Median time from conclusion of operation to discharge was less than 5 h. No patients expressed dissatisfaction with early discharge on follow-up interview.. LF can be safely performed as an ambulatory procedure. Analgesic and anesthetic management should be tailored to minimize nausea and provide adequate pain control.

Topics: Adult; Aged; Ambulatory Surgical Procedures; Analgesics, Non-Narcotic; Analgesics, Opioid; Anesthetics, Inhalation; Anesthetics, Intravenous; Anesthetics, Local; Bupivacaine; Diet; Enteral Nutrition; Female; Fundoplication; Hospitalization; Humans; Hydrocodone; Injections, Subcutaneous; Ketorolac; Laparoscopy; Length of Stay; Male; Middle Aged; Nausea; Oxycodone; Pain, Postoperative; Patient Education as Topic; Patient Readmission; Patient Satisfaction; Postoperative Care; Premedication; Propofol; Tolmetin; Urinary Retention

Topics: Codeine; Humans; Hydrocodone; Pain, Postoperative; Tooth, Impacted