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

Satisfaction Clinical Trial

Official title:

Remifentanil as Analgesia for Labour Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202722
• Other study ID #: SSHF812310
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: May 22, 2014
• Start date: January 2004
• Est. completion date: August 2007

Study information

• Verified date: May 2014
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Description:

Primary and secondary outcome measures presented under "results"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Adverse Effects
• Labor Pain
• Labour Pain
• Satisfaction

Intervention

Drug:
• Remifentanil
Intravenous patient controlled analgesia (ivpca) during labour

Locations

Country	Name	City	State
Norway	Sorlandet sykehus HF	Kristiansand	Vest-Agder

Sponsors (1)

Lead Sponsor	Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)	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.	From start with remifentanil treatment until delivery, up to 8 hours.	No
Secondary	Patient Satisfaction	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.	From start of remifentanil treatment until delivery	Yes