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

Phase 4

Completed

Conditions: Labour Pain
Satisfaction
Adverse Effects

Interventions: Drug: Remifentanil

Registration Number: NCT00202722

Lead Sponsor: Sorlandet Hospital HF

Brief 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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 41

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remifentanil IVPCA	Remifentanil	Bolus dose steps of 0.15 microgr/kg, with a 2-min lock-out time

Primary Outcome Measures

Name	Time	Method
Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)	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 Outcome Measures

Name	Time	Method
Patient Satisfaction	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.