Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-04-30

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

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Detailed Description

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Conditions

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Breech Presentation Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Remifentanil

Group Type EXPERIMENTAL

remifentanil

Intervention Type DRUG

intervention: intravenous paracetamol 1g and remifentanil 1mg/100ml in 100ml of 0.9% saline.

Paracetamol

intravenous paracetamol 1g

Group Type ACTIVE_COMPARATOR

paracetamol

Intervention Type DRUG

Control group: intravenous paracetamol 1g

Interventions

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remifentanil

intervention: intravenous paracetamol 1g and remifentanil 1mg/100ml in 100ml of 0.9% saline.

Intervention Type DRUG

paracetamol

Control group: intravenous paracetamol 1g

Intervention Type DRUG

Other Intervention Names

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acetoaminophen

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes