title: Pre-emptive effect of ibuprofen versus placebo on pain relief and success rates of medical abortion: a double-blind, randomized, controlled study.
abstract: 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.
  
  
  METHODS
  Prospective, double-blind, randomized, controlled study.
  
  
  METHODS
  University-affiliated tertiary hospital.
  
  
  METHODS
  Sixty-one women who underwent first-trimester termination of pregnancy.
  
  
  METHODS
  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.
  
  
  METHODS
  Significant pain, assessed by the need for additional analgesia, and failure rates, defined by a need for surgical intervention.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT00997074.
authors.affiliation: Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, affiliated with the Sackler School of Medicine, Tel-Aviv University, Tel Hashomer, Israel.
authors.forename: Sarit
authors.initials: S
authors.lastname: Avraham
authors.forename: Itai
authors.initials: I
authors.lastname: Gat
authors.forename: Nir-Ram
authors.initials: NR
authors.lastname: Duvdevani
authors.forename: Jigal
authors.initials: J
authors.lastname: Haas
authors.forename: Yair
authors.initials: Y
authors.lastname: Frenkel
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Seidman
mesh_terms: D000020:Abortifacient Agents, Nonsteroidal / Q000008:administration & dosage / Q000009:adverse effects*; D000021:Abortifacient Agents, Steroidal / Q000008:administration & dosage / Q000009:adverse effects*; D000028:Abortion, Induced / Q000009:adverse effects*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006785:Hospitals, University; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage* / Q000009:adverse effects; D007557:Israel; D016015:Logistic Models; D008875:Middle Aged; D015735:Mifepristone / Q000008:administration & dosage / Q000009:adverse effects*; D016595:Misoprostol / Q000008:administration & dosage / Q000009:adverse effects*; D016017:Odds Ratio; D010146:Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D010147:Pain Measurement; D010919:Placebos; D011247:Pregnancy; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000020:Abortifacient Agents, Nonsteroidal; D000021:Abortifacient Agents, Steroidal; D000894:Anti-Inflammatory Agents, Non-Steroidal; D010919:Placebos; D016595:Misoprostol; D015735:Mifepristone; D007052:Ibuprofen