Clinical Trial: Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Remifentanil Versus Placebo for Pain Treatment External Cephalic Versions. Randomized, Controlled and Masked
Brief 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
Detailed Summary:
Sponsor: Basque Health Service
Current Primary Outcome: Degree of decrease in pain experienced by patients during the maneuver according to the VAS [ Time Frame: 10 minutes ]
Original Primary Outcome: Degree of decrease in pain experienced by patients during the maneuver according to the VAS [ Time Frame: 10 y 45 minutes ]
Current Secondary Outcome:
- Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section. [ Time Frame: 1 day ]
- Number of adverse events and severity [ Time Frame: 1 day ]
Original Secondary Outcome: Same as current
Information By: Basque Health Service
Dates:
Date Received: January 12, 2010
Date Started: June 2010
Date Completion:
Last Updated: April 13, 2011
Last Verified: September 2010
