Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

NCT01048398 | Completed Phase 3

• 1 other identifier: REMI-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Breech Presentation; Pregnancy

Keywords

ceophalic version; breech presentation; pregnancy; remifentanil; paracetamol

Outcome Measures

Primary Outcomes (1)

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

  10 minutes

Secondary Outcomes (2)

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

  1 day

• Number of adverse events and severity

  1 day

Study Arms (2)

Remifentanil

EXPERIMENTAL

Drug: remifentanil

Paracetamol

ACTIVE COMPARATOR

intravenous paracetamol 1g

Drug: paracetamol

Interventions

remifentanil DRUG

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

Remifentanil

paracetamol DRUG

Control group: intravenous paracetamol 1g

Also known as: acetoaminophen

Paracetamol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Basque Health Service: lead

Study Sites (1)

Hospital Txagorritxu

Vitoria-Gasteiz, Alava, 01009, Spain

Location

MeSH Terms

Conditions

Breech Presentation

Interventions

Remifentanil; Acetaminophen

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Cesar A Valero, MD

  Basque Health Service

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 14, 2011

Record last verified: 2010-09

Locations

ES (1)