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

NCT00202722 | Completed Phase 4 Results DMC

• 1 other identifier: SSHF812310
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Labour Pain; Satisfaction; Adverse Effects

Keywords

Remifentanil, parenteral opioids, obstetric analgesia, IVPCA

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Patient Satisfaction

  From start of remifentanil treatment until delivery

Study Arms (1)

Remifentanil IVPCA

ACTIVE COMPARATOR

Bolus dose steps of 0.15 microgr/kg, with a 2-min lock-out time

Drug: Remifentanil

Interventions

Remifentanil DRUG

Intravenous patient controlled analgesia (ivpca) during labour

Also known as: Ultiva

Remifentanil IVPCA

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy women (ASA I-II), in active labour, one fetus with no suspected pathology, expecting normal childbirth, informed consent.

You may not qualify if:

• Failure to obtain informed consent, received opioids within last 8 hours before study start, serious side-effects mother and abnormal fetal heart rate.

Sponsors & Collaborators

• Sorlandet Hospital HF: lead

Study Sites (1)

Sorlandet sykehus HF

Kristiansand, Vest-Agder, N-4623, Norway

Location

Related 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. doi: 10.1093/bja/87.3.415.

  PMID: 11517125 BACKGROUND

MeSH Terms

Conditions

Labor Pain; Personal Satisfaction

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Tor Tveit
• Organization: Sorlandet Hospital HF

tor.tveit@sshf.no

+4738073608

Study Officials

• Jan H. Rosland, Professor

  part time

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: August 1, 2007
• Last Updated: June 23, 2014
• Results First Posted: June 23, 2014

Record last verified: 2014-05

Locations

NO (1)