Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

April 13, 2011 updated by: Basque Health Service

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alava
      • Vitoria-Gasteiz, Alava, Spain, 01009
        • Hospital Txagorritxu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remifentanil
Drug: remifentanil
intervention: intravenous paracetamol 1g and remifentanil 1mg/100ml in 100ml of 0.9% saline.
Active Comparator: Paracetamol
intravenous paracetamol 1g
Drug: paracetamol
Control group: intravenous paracetamol 1g
Other Names:
  • acetoaminophen

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section.
Time Frame: 1 day
1 day
Number of adverse events and severity
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basque Health Service

Investigators

  • Principal Investigator: Cesar A Valero, MD, Basque Health Service
  • Study Chair: Henar Muñoz, MD, Basque Health Service
  • Study Chair: Amanda Lopez, Basque Health Service
  • Study Chair: Sandra Guerra, MD, Basque Health Service
  • Study Chair: Olga Echebarria, MD, Basque Health Service
  • Study Chair: Alfonso Velasco, MD, University of Valladolid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Estimate)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 13, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REMI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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