Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

Phase 3

Completed

• Conditions: Breech Presentation; Pregnancy
• Interventions: Drug: paracetamol; Drug: remifentanil

• Registration Number: NCT01048398
• Lead Sponsor: Basque Health Service

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 Description

Not available

Study Timeline

• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Study Start: 2010-06
• Status Verified: 2010-09
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Fetuses between weeks 36 and 41 of gestation confirmed by ultrasound with non-cephalic presentation.
• Informed consent signed by the mother or legal representative in his absence.

Exclusion Criteria

• Fetal anomalies
• Severe hypertension
• Allergy to drug used in the test
• Amniotic fluid index ≥ 5 cm
• Contraindication for vaginal delivery
• Uterine abnormality and impaired coagulation
• Placenta previa
• Rh sensitization
• Multiple gestation
• Ruptured membranes
• Premature detachment of normally inserted placenta
• The mother greater weight to 85kg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracetamol	paracetamol	intravenous paracetamol 1g
Remifentanil	remifentanil	-

Primary Outcome Measures

Name	Time	Method
Degree of decrease in pain experienced by patients during the maneuver according to the VAS	10 minutes

Secondary Outcome Measures

Name	Time	Method
Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section.	1 day
Number of adverse events and severity	1 day

Trial Locations

Locations (1)

Hospital Txagorritxu; 🇪🇸 Vitoria-Gasteiz, Alava, Spain