hydrocodone and Vomiting

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 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

Gastrointestinal (GI) adverse effects are common with oral opioid treatment.. To estimate the costs associated with GI events after oral short-acting opioid treatment, from the payer perspective.. Medical and pharmacy claims from the PharMetrics' Patient-Centric Database were used to identify opioid-naïve patients who received a new prescription for oxycodone- or hydrocodone-containing immediate-release oral products between 2002 and 2006. Health-care resource use and costs were determined for patients with claims associated with ICD-9 CM (International Classification of Diseases-9th Clinical Modification) codes for nausea/vomiting (787.0x), constipation (564.0x), bowel obstruction (560, 560.1, 560.3, 560.39, 564.81), or antiemetic and laxative prescriptions during the 3 months after opioid index prescription and compared with patients without these GI event medical or prescription claims. Resource use data were compared using negative binomial regression and cost data were compared using ordinary least squares confirmed by generalized gamma regression analysis while controlling for demographics, treatment duration, and comorbidities.. Data from 237,447 patients were analyzed. Patients with GI event claims had significantly more hospitalizations (adjusted mean 0.20 to 0.97 vs 0.17, respectively, p < 0.001), days in the hospital (1.12 to 12.05 vs 1.00 days, p < 0.001), emergency department visits (0.36 to 1.44 vs 0.25 visits, p < 0.001), outpatient office visits (5.68 to 11.81 vs 4.11 visits, p < 0.001), and prescription claims (7.46 to 8.21 vs 6.06 claims, p < 0.001) than did patients without any GI event claims in the 3 months after index opioid prescription. Compared with patients without any GI event claims, incremental adjusted mean total health-care costs for patients with any of the GI event claims ranged from $4,880 to $36,152 and were significant (p < 0.001).. The economic burden of GI events coincident with opioid treatment is significant for patients with a GI event recorded in claims. Reducing GI adverse effects has potential cost savings for the health-care system.

Topics: Adult; Aged; Ambulatory Care; Analgesics, Opioid; Cohort Studies; Constipation; Databases, Factual; Drug Prescriptions; Drug Utilization; Emergency Medical Services; Female; Gastrointestinal Diseases; Humans; Hydrocodone; Insurance, Health, Reimbursement; Intestinal Obstruction; Male; Middle Aged; Nausea; Oxycodone; Pain; Retrospective Studies; Socioeconomic Factors; United States; Vomiting