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Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

NCT01048398 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-04-14

No results posted yet for this study

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

Conditions

  • Breech Presentation
  • Pregnancy

Interventions

DRUG

remifentanil

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

DRUG

paracetamol

Control group: intravenous paracetamol 1g

Sponsors & Collaborators

  • Basque Health Service

    lead OTHER_GOV

Principal Investigators

  • Cesar A Valero, MD · Basque Health Service

  • Henar Muñoz, MD · Basque Health Service

  • Amanda Lopez · Basque Health Service

  • Sandra Guerra, MD · Basque Health Service

  • Olga Echebarria, MD · Basque Health Service

  • Alfonso Velasco, MD · University of Valladolid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01048398 on ClinicalTrials.gov