Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

Basque Health Service60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Breech Presentation Pregnancy

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Degree of decrease in pain experienced by patients during the maneuver according to the VAS

Time frame: 10 minutes

Secondary Outcomes

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