Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

Study Overview
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Brief Summary
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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

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

Conditions
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Breech Presentation, Pregnancy

Intervention / Treatment
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* Drug: remifentanil
* Drug: paracetamol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remifentanil<br> | Drug: remifentanil<br>* intervention: intravenous paracetamol 1g and remifentanil 1mg/100ml in 100ml of 0.9% saline.<br>|
| Active Comparator: Paracetamol<br>intravenous paracetamol 1g | Drug: paracetamol<br>* Control group: intravenous paracetamol 1g<br>* Other names: acetoaminophen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of decrease in pain experienced by patients during the maneuver according to the VAS |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ceophalic version, breech presentation, pregnancy, remifentanil, paracetamol