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OpenTrials
Completed

NCT Number: NCT01048398

Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

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

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Key information

Conditions

Breech Presentation Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Txagorritxu

Vitoria-Gasteiz, Alava, 01009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

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

Paracetamol

Drug

Control group: intravenous paracetamol 1g

Other names: acetoaminophen

Primary outcomes

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

    Time frame: 10 minutes

Secondary outcomes

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

    Time frame: 1 day

  2. Number of adverse events and severity

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 13, 2010
Registry last updated
Apr 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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