At a glance
ClinicalIndex Comparison Record- ✓Healthy women with ASA physical status I-II
- ✓In active labour
- ✓Single fetus with no suspected pathology
- ✓Expecting normal childbirth
- ✕Receipt of opioids within 8 hours before study start
- ✕Serious side effects in mother
- ✕Abnormal fetal heart rate
- ✕Failure to obtain informed consent
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Remifentanil as Analgesia for Labour Pain
In Brief
A Phase 4 clinical trial evaluating Remifentanil for Labour Pain and 2 related conditions. Completed, enrolled 41 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Intravenous patient controlled analgesia (ivpca) during labour