Pre-emptive effect of ibuprofen versus placebo on pain relief and success rates of medical abortion: a double-blind, randomized, controlled study

Fertil Steril. 2012 Mar;97(3):612-5. doi: 10.1016/j.fertnstert.2011.12.041. Epub 2012 Jan 20.


Objective: To determine the efficacy of pre-emptive administration of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen vs. a placebo on pain relief during medical abortion and to evaluate whether NSAIDs interfere with the action of misoprostol.

Design: Prospective, double-blind, randomized, controlled study.

Setting: University-affiliated tertiary hospital.

Patient(s): Sixty-one women who underwent first-trimester termination of pregnancy.

Intervention(s): Patients received 600 mg mifepristone orally, followed by 400 μg oral misoprostol 2 days later. They were randomized to receive pre-emptively two tablets of 400 mg ibuprofen orally or a placebo, when taking the misoprostol. The patients completed a questionnaire about side effects and pain score and returned for an ultrasound follow-up examination 10-14 days after the medical abortion.

Main outcome measure(s): Significant pain, assessed by the need for additional analgesia, and failure rates, defined by a need for surgical intervention.

Result(s): Pre-emptive ibuprofen treatment was found to be more effective than a placebo in pain prevention, as determined by a significantly lower need for additional analgesia: 11 of 29 (38%) vs. 25 of 32 (78%), respectively. Treatment failure rate was not statistically different between the ibuprofen and placebo groups: 4 of 28 (14.2%) vs. 3 of 31 (9.7%), respectively. History of menstrual pain was predictive for the need of additional analgesia.

Conclusion(s): Pre-emptive use of ibuprofen had a statistically significant beneficial effect on the need for pain relief during a mifepristone and misoprostol regimen for medical abortion. Ibuprofen did not adversely affect the outcome of medical abortion.

Clinical trial registration number: NCT00997074.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Abortifacient Agents, Nonsteroidal / administration & dosage
  • Abortifacient Agents, Nonsteroidal / adverse effects*
  • Abortifacient Agents, Steroidal / administration & dosage
  • Abortifacient Agents, Steroidal / adverse effects*
  • Abortion, Induced / adverse effects*
  • Administration, Oral
  • Adolescent
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Chi-Square Distribution
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Hospitals, University
  • Humans
  • Ibuprofen / administration & dosage*
  • Ibuprofen / adverse effects
  • Israel
  • Logistic Models
  • Middle Aged
  • Mifepristone / administration & dosage
  • Mifepristone / adverse effects*
  • Misoprostol / administration & dosage
  • Misoprostol / adverse effects*
  • Odds Ratio
  • Pain / diagnosis
  • Pain / etiology
  • Pain / prevention & control*
  • Pain Measurement
  • Placebos
  • Pregnancy
  • Prospective Studies
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Young Adult


  • Abortifacient Agents, Nonsteroidal
  • Abortifacient Agents, Steroidal
  • Anti-Inflammatory Agents, Non-Steroidal
  • Placebos
  • Misoprostol
  • Mifepristone
  • Ibuprofen

Associated data