Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions. - Full Text View

Sponsor:	Basque Health Service
Information provided by:	Basque Health Service
ClinicalTrials.gov Identifier:	NCT01048398

Purpose

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

Condition	Intervention	Phase
Breech Presentation Pregnancy	Drug: remifentanil Drug: paracetamol	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	Remifentanil Versus Placebo for Pain Treatment External Cephalic Versions. Randomized, Controlled and Masked

Resource links provided by NLM:

Drug Information available for: Acetaminophen Remifentanil hydrochloride Remifentanil CT 2584

U.S. FDA Resources

Further study details as provided by Basque Health Service:

Primary Outcome Measures:

Degree of decrease in pain experienced by patients during the maneuver according to the VAS [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Number of adverse events and severity [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	June 2010
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: acetoaminophen

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048398

Locations

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

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	Cesar Augusto Valero Martinez, Hospital Txagorritxu
ClinicalTrials.gov Identifier:	NCT01048398 History of Changes
Other Study ID Numbers:	REMI-001
Study First Received:	January 12, 2010
Last Updated:	April 13, 2011
Health Authority:	Spain: Ethics Committee; Spain: Spanish Agency of Medicines

Keywords provided by Basque Health Service:

ceophalic version
breech presentation
pregnancy
remifentanil
paracetamol

Additional relevant MeSH terms:

Breech Presentation
Obstetric Labor Complications
Pregnancy Complications
Acetaminophen
Remifentanil
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on February 09, 2012