Phase 4
Completed N=41
Remifentanil as Intravenous Patient-controlled Analgesia (IVPCA) During Labour
Labour Pain · Satisfaction · Adverse Effects
Source: ClinicalTrials.gov NCT00202722 ↗
Enrolled (actual)
41
Serious AEs
26.8%
Results posted
Jun 2014
Primary outcomePrimary: Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain) — 47 millimeters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain) |
47 | — |
| SECONDARY Patient Satisfaction |
37 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00202722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.