Hydrocodone-acetaminophen for pain control in first-trimester surgical abortion: a randomized controlled trial.

Elizabeth A Micks, Alison B Edelman, Regina-Maria Renner, Rongwei Fu, William E Lambert, Paula H Bednarek, Mark D Nichols, Ethan H Beckley, Jeffrey T Jensen

Department of Public Health, School of Medicine, Oregon Health & Science University, Portland, Oregon, USA. emicks@u.washington.edu

Obstetrics and gynecology 2012 Nov

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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.

Citation

Elizabeth A Micks, Alison B Edelman, Regina-Maria Renner, Rongwei Fu, William E Lambert, Paula H Bednarek, Mark D Nichols, Ethan H Beckley, Jeffrey T Jensen. Hydrocodone-acetaminophen for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstetrics and gynecology. 2012 Nov;120(5):1060-9