NCT01048398

Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

Remifentanil Versus Placebo for Pain Treatment External Cephalic Versions. Randomized, Controlled and Masked

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Basque Health Service · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Breech Presentation
• Pregnancy

Interventions

Type	Name	Description
DRUG	remifentanil	intervention: intravenous paracetamol 1g and remifentanil 1mg/100ml in 100ml of 0.9% saline.
DRUG	paracetamol	Control group: intravenous paracetamol 1g

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-01-13
• Last updated: 2011-04-14

Locations

1 site across 1 country: Spain