Kari M Plewniak1, Emily Kintzer2, Ruth Eisenberg3, Melissa Fazzari3, Ja Hyun Shin2. 1. Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology and Women's Health, Montefiore Medical Center (Drs. Plewniak, Kintzer, and Shin). Electronic address: KPlewnia@Montefiore.org. 2. Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics and Gynecology and Women's Health, Montefiore Medical Center (Drs. Plewniak, Kintzer, and Shin). 3. Department of Epidemiology and Population Health, Albert Einstein College of Medicine (Dr. Fazzari and Ms. Eisenberg), Bronx, New York.
Abstract
STUDY OBJECTIVE: To examine whether prescribing 5 tablets, as opposed to 10 tablets, of 5-mg oxycodoneadequately treats pain after gynecologic laparoscopy. DESIGN: Single-blinded randomized trial. SETTING:Academically affiliated ambulatory surgery center. PATIENTS: One hundred twenty women scheduled to undergo minor gynecologic laparoscopy. INTERVENTIONS:Patients scheduled for ambulatory gynecologic laparoscopy were allocated to the standard tablet or low-tablet number prescription groups (10 tablets or 5 tablets of 5-mg oxycodone). The patients also received prescriptions for acetaminophen and ibuprofen. MEASUREMENTS AND MAIN RESULTS: Telephone surveys were conducted on postoperative days 1 and 7 to assess medication use and pain. The primary outcome was the number of oxycodone tablets used by days 1 and 7. Prespecified secondary outcomes included unscheduled patient contacts and pain scores. With N = 50 in each group and assuming standardized effect sizes, the study was powered to detect a 0.6 difference or greater when comparing the primary outcome between the groups. Forty-five and 47 patients in the 5-tablet and 10-tablet groups, respectively, completed the day-7 survey. The median number of oxycodone tablets taken by day 7 was 2.0 (interquartile range 0.0, 4.0) in the 5-tablet group and 2.5 (interquartile range 0.0, 5.0) in the 10-tablet group (p = .36). Most of the patients in both groups reported taking 3 oxycodone tablets or fewer by day 7. There were no significant differences in unscheduled patient contacts, need for additional prescriptions, or pain scores. There were significantly fewer unused tablets in the 5-tablet group by day 7. CONCLUSION: Prescribing 5 tablets of 5-mg oxycodone, acetaminophen, and ibuprofen is likely sufficient for most patients after minor laparoscopic surgery.
RCT Entities:
STUDY OBJECTIVE: To examine whether prescribing 5 tablets, as opposed to 10 tablets, of 5-mg oxycodone adequately treats pain after gynecologic laparoscopy. DESIGN: Single-blinded randomized trial. SETTING: Academically affiliated ambulatory surgery center. PATIENTS: One hundred twenty women scheduled to undergo minor gynecologic laparoscopy. INTERVENTIONS:Patients scheduled for ambulatory gynecologic laparoscopy were allocated to the standard tablet or low-tablet number prescription groups (10 tablets or 5 tablets of 5-mg oxycodone). The patients also received prescriptions for acetaminophen and ibuprofen. MEASUREMENTS AND MAIN RESULTS: Telephone surveys were conducted on postoperative days 1 and 7 to assess medication use and pain. The primary outcome was the number of oxycodone tablets used by days 1 and 7. Prespecified secondary outcomes included unscheduled patient contacts and pain scores. With N = 50 in each group and assuming standardized effect sizes, the study was powered to detect a 0.6 difference or greater when comparing the primary outcome between the groups. Forty-five and 47 patients in the 5-tablet and 10-tablet groups, respectively, completed the day-7 survey. The median number of oxycodone tablets taken by day 7 was 2.0 (interquartile range 0.0, 4.0) in the 5-tablet group and 2.5 (interquartile range 0.0, 5.0) in the 10-tablet group (p = .36). Most of the patients in both groups reported taking 3 oxycodone tablets or fewer by day 7. There were no significant differences in unscheduled patient contacts, need for additional prescriptions, or pain scores. There were significantly fewer unused tablets in the 5-tablet group by day 7. CONCLUSION: Prescribing 5 tablets of 5-mg oxycodone, acetaminophen, and ibuprofen is likely sufficient for most patients after minor laparoscopic surgery.