drugset / Trial / NCT01048398

Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

NCT01048398

Phase 3 Completed 60 enrolled Basque Health Service
RandomizedParallel-groupDouble-blindTreatment

Summary

BACKGROUND: Between 3-4% of pregnancies carried to term, the fetuses are in breech presentation. The external version is a maneuver gynecological used to turn a breech in cephalic presentation. For treatment of pain suggests the use of μ agonist remifentanil for fast action and elimination. OBJECTIVE: To compare the effectiveness of remifentanil for pain management in external version. PATIENTS: Pregnant for 36 weeks or more with breech presentation who met the inclusion criteria and sign the consent. Participants will be randomized into two groups before the procedure. Group intervention: paracetamol and remifentanil Control group: paracetamol and placebo DETERMINATIONS: VAS pain level, percentage of success of the maneuver and adverse events. Statistical Analysis: Comparison of pain recorded by VAS in both groups and comparison of adverse events

Timeline

Start
2010-06
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Remifentanil Small molecule 1 mg Intravenous
Comparator Acetaminophen Small molecule 1 g Intravenous

Indications