drugset / Trial / NCT00997074

Efficacy Study of Prophylactic Ibuprofen Versus Placebo on Pain Relief and Success Rates of Medical Abortion

NCT00997074 ↗

Phase 3 Completed 61 enrolled Sheba Medical Center
RandomizedParallel-groupTriple-blindTreatment

Summary

In the current study, we want to evaluate the prophylactic use of ibuprofen versus a placebo for medical abortion by mifepristone and misoprostol, at a gestational age of up to 7 weeks, in regard to the effect on pain relief and the overall procedure success. expected results: The prophylactic use of NSAIDs could offer significant pain relief and thereby a reduction in the need for additional pain relievers compared to the placebo, without interfering with the outcome of medical abortion

Timeline

Start
2009-10
Primary completion
2010-10
Completion
2010-10

Outcome

Mixed primary results

paper 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. PMID 22265034 ↗

paper 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. PMID 22265034 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibuprofen Small molecule 800 mg Oral

Indications