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

Information source: Sorlandet Hospital HF
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Labour Pain; Satisfaction; Adverse Effects

Intervention: Remifentanil (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sorlandet Hospital HF

Official(s) and/or principal investigator(s):
Jan H. Rosland, Professor, Study Chair, Affiliation: part time


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.

Clinical Details

Official title: Remifentanil as Analgesia for Labour Pain

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)

Secondary outcome: Patient Satisfaction

Detailed description: Primary and secondary outcome measures presented under "results"


Minimum age: N/A. Maximum age: N/A. Gender(s): Female.


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.

Locations and Contacts

Sorlandet sykehus HF, Kristiansand, Vest-Agder N-4623, Norway
Additional Information

Related publications:

Blair JM, Hill DA, Fee JP. Patient-controlled analgesia for labour using remifentanil: a feasibility study. Br J Anaesth. 2001 Sep;87(3):415-20.

Starting date: January 2004
Last updated: May 22, 2014

Page last updated: August 23, 2015

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