Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01048398

Enrollment

Registered

2010-01-13

Start date

2010-06-30

Completion date

2011-04-30

Last updated

2011-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breech Presentation, Pregnancy

Keywords

ceophalic version, breech presentation, pregnancy, remifentanil, paracetamol

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

Interventions

DRUGremifentanil

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

DRUGparacetamol

Control group: intravenous paracetamol 1g

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Degree of decrease in pain experienced by patients during the maneuver according to the VAS	10 minutes

Secondary

Measure	Time frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026