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Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

Primary Purpose

Breech Presentation, Pregnancy

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

remifentanil

paracetamol

About this trial

This is an interventional treatment trial for Breech Presentation focused on measuring ceophalic version, breech presentation, pregnancy, remifentanil, paracetamol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Hospital Txagorritxu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remifentanil

Paracetamol

Arm Description

intravenous paracetamol 1g

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section.

Number of adverse events and severity

Full Information

NCT ID

NCT01048398

First Posted

January 12, 2010

Last Updated

April 13, 2011

Sponsor

Basque Health Service

1. Study Identification

Unique Protocol Identification Number

NCT01048398

Brief Title

Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Basque Health Service

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breech Presentation, Pregnancy

Keywords

ceophalic version, breech presentation, pregnancy, remifentanil, paracetamol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Remifentanil

Arm Type

Experimental

Arm Title

Paracetamol

Arm Type

Active Comparator

Arm Description

intravenous paracetamol 1g

Intervention Type

Drug

Intervention Name(s)

remifentanil

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

paracetamol

Other Intervention Name(s)

acetoaminophen

Intervention Description

Control group: intravenous paracetamol 1g

Primary Outcome Measure Information:

Title

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

Time Frame

10 minutes

Secondary Outcome Measure Information:

Title

Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section.

Time Frame

1 day

Title

Number of adverse events and severity

Time Frame

1 day

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: