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
Summary
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"
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
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