Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Basque Health Service
• Treatments: Acetaminophen; Remifentanil

Criteria

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