title: Hydrocodone-acetaminophen for pain control in first-trimester surgical abortion: a randomized controlled trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Hydrocodone-acetaminophen does not decrease pain during first-trimester abortion and may increase postoperative nausea.
  
  
  BACKGROUND
  Clinicaltrials.gov, www.clinicaltrials.gov, NCT01330459.
  
  
  METHODS
  I.
authors.affiliation: Department of Public Health, School of Medicine, Oregon Health & Science University, Portland, Oregon, USA. emicks@u.washington.edu
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Micks
authors.forename: Alison B
authors.initials: AB
authors.lastname: Edelman
authors.forename: Regina-Maria
authors.initials: RM
authors.lastname: Renner
authors.forename: Rongwei
authors.initials: R
authors.lastname: Fu
authors.forename: William E
authors.initials: WE
authors.lastname: Lambert
authors.forename: Paula H
authors.initials: PH
authors.lastname: Bednarek
authors.forename: Mark D
authors.initials: MD
authors.lastname: Nichols
authors.forename: Ethan H
authors.initials: EH
authors.lastname: Beckley
authors.forename: Jeffrey T
authors.initials: JT
authors.lastname: Jensen
mesh_terms: D000028:Abortion, Induced; D000082:Acetaminophen / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects / Q000627:therapeutic use*; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006853:Hydrocodone / Q000009:adverse effects / Q000627:therapeutic use*; D059408:Pain Management / Q000379:methods*; D058748:Pain Perception; D010149:Postoperative Pain / Q000188:drug therapy*; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D055815:Young Adult
chemical_list: D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D004338:Drug Combinations; C083640:acetaminophen, hydrocodone drug combination; D000082:Acetaminophen; D006853:Hydrocodone