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Individualized Compared With Standard Postdischarge Oxycodone Prescribing After Cesarean Birth: A Randomized Controlled Trial.

ABSTRACT: OBJECTIVE:To evaluate whether individualized postdischarge oxycodone prescribing guided by inpatient opioid use reduces the number of unused opioid tablets after cesarean birth. METHODS:We conducted a randomized, controlled trial of women aged 18 years or older undergoing cesarean birth. Participants were randomized at discharge in a 1:1 ratio to a standard (30 tablets of 5 mg oxycodone) or an individualized oxycodone prescription (predicted based on each patient's inpatient opioid use). All women were contacted starting 14 days after cesarean birth to assess number of oxycodone tablets used and adequacy of pain control. The Tennessee Controlled Substance Monitoring Database was accessed to confirm dispensed opioids. The primary outcome was number of unused oxycodone tablets prescribed for pain control after cesarean birth. A total sample size of 160 women was necessary to detect a 30% difference in leftover tablets between groups with 80% power and ? of 0.05. RESULTS:Between June 14, 2017, and August 26, 2017, we screened 323 women and randomized 172. Baseline characteristics and inpatient opioid use were similar between groups. Women in the individualized group were prescribed fewer tablets (14 [interquartile range 12-16] vs 30 [interquartile range 30-30], P<.001) and had 50% fewer unused tablets than women in the standard group (5 [interquartile range 1-8] vs 10 [interquartile range 0-22], P<.001). Overall, 13% (23/172) used no opioids after discharge and 26% (44/172) used all prescribed opioids. There were no differences between the standard and individualized groups in the proportion of women who used no opioids or all opioids and no difference in the proportion of dispensed opioids used (60% [interquartile range 23-100] vs 61% [29-89], P=.93). Women in the individualized group used only half the number of prescribed opioids as women in the standard group (8 [interquartile range 4-14] vs 15 [interquartile range 6-30], P<.001). Patient-reported pain outcomes did not differ significantly by group. CONCLUSION:Individualized opioid prescribing based on inpatient use reduces the number of unused oxycodone tablets compared with standard prescribing. CLINICAL TRIALS REGISTRATION:ClinicalTrials.gov, NCT03168425.

SUBMITTER: Osmundson SS

PROVIDER: S-EPMC6105453 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Individualized Compared With Standard Postdischarge Oxycodone Prescribing After Cesarean Birth: A Randomized Controlled Trial.

Osmundson Sarah S SS Raymond Britany L BL Kook Bradley T BT Lam LeAnn L Thompson Elizabeth B EB Schornack Leslie A LA Voorhees Catherine E CE Richardson Michael G MG

Obstetrics and gynecology 20180901 3

<h4>Objective</h4>To evaluate whether individualized postdischarge oxycodone prescribing guided by inpatient opioid use reduces the number of unused opioid tablets after cesarean birth.<h4>Methods</h4>We conducted a randomized, controlled trial of women aged 18 years or older undergoing cesarean birth. Participants were randomized at discharge in a 1:1 ratio to a standard (30 tablets of 5 mg oxycodone) or an individualized oxycodone prescription (predicted based on each patient's inpatient opioi ...[more]

PMID: 30095773

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Project description:OBJECTIVE:To evaluate the feasibility of salpingectomy compared with standard bilateral tubal ligation at the time of cesarean delivery in women with undesired fertility. METHODS:We included women at 35 weeks of gestation or greater desiring permanent sterilization at the time of cesarean delivery. Patients were randomized after skin incision to bilateral salpingectomy or bilateral tubal ligation by a computer-generated scheme. If salpingectomy could not be completed on one or both sides, bilateral tubal ligation was attempted. Primary feasibility outcomes were total operative time and bilateral completion of the randomized procedure. Secondary outcomes included clinically estimated blood loss and surgical complications up to 6 weeks postpartum. We estimated that 80 patients (40 per group) would provide greater than 80% power to identify a 10-minute difference in the primary outcome (time) with a SD of 15 minutes and a two-sided ? of 0.05. Analysis was by intent to treat. RESULTS:Of 221 women screened from June 2015 to April 2017, 115 (52%) consented to the study; 80 were randomized-40 to salpingectomy and 40 to bilateral tubal ligation. Groups were similar at baseline. A total of 27 bilateral salpingectomies were successfully completed compared with 38 bilateral tubal ligations (68% compared with 95%, P=.002). Total operative time was on average 15 minutes longer for salpingectomies (75.4±29.1 compared with 60.0±23.3 minutes, P=.004). No adverse outcomes directly related to the sterilization procedure were noted in either group. Although estimated blood loss of only the sterilization procedure (surgeon estimate) was greater for the salpingectomy group (median 10 [interquartile range 5-25] compared with 5 [interquartile range 5-10] cc, P<.001), total estimated blood loss and safety outcomes were similar for both groups. CONCLUSION:Adding 15 minutes to total operative times, salpingectomy can be successfully completed in approximately two thirds of women desiring permanent contraception with cesarean delivery. CLINICAL TRIAL REGISTRATION:Clinicaltrials.gov, NCT02374827.

Project description:BACKGROUND:Abuse-deterrent formulations attempt to address public health and societal concerns regarding opioid abuse. Oxycodone HCl-niacin tablets combine oxycodone HCl with niacin and functional inactive excipients to create potential barriers to oral, intranasal, and intravenous abuse. This study compared the relative abuse potential of oral immediate-release oxycodone HCl-niacin with that of oral immediate-release oxycodone HCl and placebo in nondependent, recreational opioid users. METHODS:Forty-nine participants received oxycodone HCl-niacin 40/240 mg and 80/480 mg, oxycodone 40 mg and 80 mg, and placebo in a randomized, double-blind, placebo-controlled and active-controlled, five-way crossover study. Primary endpoints based on a bipolar 100 mm visual analog scale for drug liking were area under effect curve (AUE0-1h, AUE0-2h, AUE0-3h), peak disliking, and effect at 0.5 hours post-dose (E0.5h). Other endpoints included take drug again assessment, overall drug liking, and pupillometry. RESULTS:There were statistically significant differences between oxycodone HCl-niacin and oxycodone HCl doses for all primary endpoints (P < 0.0001, all comparisons), suggesting reduced abuse potential with oxycodone HCl-niacin. Take drug again and overall drug liking showed greater liking of oxycodone alone. Oxycodone HCl-niacin 80/480 mg had consistently lower liking assessments than oxycodone HCl-niacin 40/240 mg, suggesting a dose-response to the aversive effects of niacin. Opioid-related adverse events were similar for equivalent oxycodone doses. The treatment-emergent adverse events most specifically associated with oxycodone HCl-niacin (ie, skin-burning sensation, warmth, and flushing) were consistent with the expected vasocutaneous effects of niacin. No serious adverse events were reported. CONCLUSION:Oxycodone HCl-niacin tablets may, in a dose-dependent manner, decrease the potential for oral abuse of oxycodone without unexpected adverse events or clinically signifi-cant differences in safety parameters compared with oxycodone alone. Although statistically powered, the small size of the study sample and the characteristics of its participants may not be generalizable to the population that abuses prescription opioid medications.

Project description:Controlled-release oxycodone/naloxone (OXN-CR) maintains the effect of opioid-induced analgesia through oxycodone while reducing the occurrence rate of opioid-induced constipation through naloxone. The present study was designed to assess the non-inferiority of OXN-CR to controlled-release oxycodone (OX-CR) for the control of cancer-related pain in Korean patients.In this randomized, open-labeled, parallel-group, phase IV study, we enrolled patients aged 20 years or older with moderate to severe cancer-related pain [numeric rating scale (NRS) pain score ?4] from seven Korean oncology/hematology centers. Patients in the intention-to-treat (ITT) population were randomized (1:1) to OXN-CR or OX-CR groups. OXN-CR was administered starting at 20 mg/10 mg per day and up-titrated to a maximum of 80 mg/40 mg per day for 4 weeks, and OX-CR was administered starting at 20 mg/day and up-titrated to a maximum of 80 mg/day for 4 weeks. The primary efficacy endpoint was the change in NRS pain score from baseline to week 4, with non-inferiority margin of -1.5. Secondary endpoints included analgesic rescue medication intake, patient-reported change in bowel habits, laxative intake, quality of life (QoL), and safety assessments.Of the ITT population comprising 128 patients, 7 with missing primary efficacy data and 4 who violated the eligibility criteria were excluded from the efficacy analysis. At week 4, the mean change in NRS pain scores was not significantly different between the OXN-CR group (n = 58) and the OX-CR group (n = 59) (-1.586 vs. -1.559, P = 0.948). The lower limit of the one-sided 95% confidence interval (-0.776 to 0.830) for the difference exceeded the non-inferiority margin (P < 0.001). The OXN-CR and OX-CR groups did not differ significantly in terms of analgesic rescue medication intake, change in bowel habits, laxative intake, QoL, and safety assessments.OXN-CR was non-inferior to OX-CR in terms of pain reduction after 4 weeks of treatment and had a similar safety profile. Studies in larger populations of Korean patients with cancer-related pain are needed to further investigate the effectiveness of OXN-CR for long-term pain control and constipation alleviation. Trial registration ClinicalTrials.gov NCT01313780, registered March 8, 2011.

Project description:ObjectiveIn the last decade, there has been an increased interest in exploring the impact of the physical birth environment on midwifery practice and women's birth experiences. This study is based on the hypothesis that the environment for birth needs greater attention to improve some of the existing challenges in modern obstetric practice, for example the increasing use of augmentation and number of interventions during delivery.Study designA randomized controlled trial was carried out to study the effect of giving birth in a specially designed "birth environment room" on the use of augmentation during labor. The study took place at the Department of Obstetrics and Gynecology, Herning Hospital, Denmark and included 680 nulliparous women in spontaneous labor at term with a fetus in cephalic presentation. Women were randomly allocated to either the "birth environment room" or a standard birth room. The primary outcome was augmentation of labor by use of oxytocin. Secondary outcomes were duration of labor, use of pharmacological pain relief, and mode of birth. Differences were estimated as relative risks (RR) and presented with 95% confidence intervals.ResultsNo difference was found on the primary outcome, augmentation of labor (29.1% in the "birth environment room" versus 30.6% in the standard room, RR 0.97; 0.89-1.08). More women in the "birth environment room" used the bathtub (60.6% versus 52.4%, RR 1.18; 1.02-1.37), whereas a tendency to lower use of epidural analgesia (22.6% versus 28.2%) did not reach statistical significance (RR 0.87; 0.74-1.02). The chance of an uncomplicated birth was almost similar in the two groups (70.6% in the "birth environment room" versus 72.6% in the standard room, RR 0.97; 0.88-1.07) as were duration of labor (mean 7.9 hours in both groups).ConclusionsBirthing in a specially designed physical birth environment did not lower use of oxytocin for augmentation of labor. Neither did it have any effect on duration of labor, use of pharmacological pain relief, and chance of birthing without complications. We recommend that future trials are conducted in birth units with greater improvement potentials.

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Individualized Compared With Standard Postdischarge Oxycodone Prescribing After Cesarean Birth: A Randomized Controlled Trial.

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Individualized Compared With Standard Postdischarge Oxycodone Prescribing After Cesarean Birth: A Randomized Controlled Trial.

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