Remifentanil as Intravenous Patient-controlled Analgesia (IVPCA) During Labour

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-08-31

Brief Summary

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Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by non-specific blood and tissue esterases. We wanted to investigate the efficacy and safety of remifentanil used as analgesia during labour. Intravenous patient controlled analgesia (ivpca) were used to administer remifentanil. Doses used were 0,15-1,05 mikrogr/kg, with a lock-out time of 2 minutes. 41 women were included in the study. Blood-pressure, heartrate, SaO2, respiration rate and sedation were recorded every 15.minute. Fetal heart rate was recorded for the whole periode of treatment (CTG, STAN). Vaginal contraction pain were assessed by the parturients every 15.minute using a Visual Analogue Scale (VAS). Midwives also recorded their impression of the parturients pain. The parturients level of sedation were recorded by anesthesiologist and midwife every 15.minute. Apgar scores were registered at 1, 5 and 10 min after delivery. Umbilical cord blood analysis regarding blood gases and concentration of remifentanil were performed. After delivery, both mother and midwife evaluated efficacy and safety; Global satisfaction score, if the remifentanil doses were sufficient, nausea, vomiting, level of sedation and dizziness.

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Detailed Description

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Primary and secondary outcome measures presented under "results"

Conditions

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Labour Pain Satisfaction Adverse Effects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Remifentanil IVPCA

Bolus dose steps of 0.15 microgr/kg, with a 2-min lock-out time

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

Intravenous patient controlled analgesia (ivpca) during labour

Interventions

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Remifentanil

Intravenous patient controlled analgesia (ivpca) during labour

Intervention Type DRUG

Other Intervention Names

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Ultiva

Eligibility Criteria

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Inclusion Criteria

Healthy women (ASA I-II), in active labour, one fetus with no suspected pathology, expecting normal childbirth, informed consent.

Exclusion Criteria

Failure to obtain informed consent, received opioids within last 8 hours before study start, serious side-effects mother and abnormal fetal heart rate.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes