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Completed

NCT Number: NCT00202722

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

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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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sorlandet sykehus HF

Kristiansand, Vest-Agder, N-4623, Norway

About this study

Primary and secondary outcome measures presented under "results"

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Remifentanil

Drug

Intravenous patient controlled analgesia (ivpca) during labour

Other names: Ultiva

Primary outcomes

  1. Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)

    Time frame: From start with remifentanil treatment until delivery, up to 8 hours.

    Continuous Visual Analogue Scale 0 - 100 millimeters (0=no pain, 100=worst imaginable pain) Registration of pain scores before start and every 15.minute during treatment with remifentanil. Result given is the maximal change in pain score (mean) compared to the baseline value at the given timepoints.

Secondary outcomes

  1. Patient Satisfaction

    Time frame: From start of remifentanil treatment until delivery

    Patient satisfaction with remifentanil pain relief by use of questionnaire answered within 24 hours after delivery. Evalutated by a 5-point scale; 1-very satisfied.......5-very dissatisfied.

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Registry information

Official study title

Remifentanil as Analgesia for Labour Pain

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Jun 23, 2014

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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