Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048398
• Other study ID #: REMI-001
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2010
• Last updated: April 13, 2011
• Start date: June 2010
• Est. completion date: April 2011

Study information

• Verified date: September 2010
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breech Presentation
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Txagorritxu	Vitoria-Gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of decrease in pain experienced by patients during the maneuver according to the VAS		10 minutes	No
Secondary	Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section.		1 day	Yes
Secondary	Number of adverse events and severity		1 day	Yes