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Intravenous Remifentanil as Patient Controlled Analgesia (Pca) in Labour
This study is currently recruiting participants.
Verified by Sorlandet Hospital HF, November 2003
Sponsored by: Sorlandet Hospital HF
Information provided by: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00202722
  Purpose

Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by non-specific blood and tissue esterases. We want to investigate the efficacy and safety of remifentanil used as analgesia in labour. Patient controlled analgesia are used to administer remifentanil i.v. The doses used are 0,15-1,05 mikrogr/kg/dose, and a lock-out time of 2 minutes. 34 women are included in the study. Bloodpressure, heartrate, SaO2, respiration rate and sedation are recorded every 15.minute. Fetal heart rate are recorded for the whole periode of treatment (CTG, STAN). Contraction pain are assessed using VAS (Visual Analogue Scale)etter 15.minute. Midwife record the impression of pain that mother express. Sedation of mother are recorded both by anesthesiologist and midwife every 15.minute for the whole periode of treatment. At delivery Apgar scores are noted at 1, 5 and 10 min. Cord blood are taken analysis of blodd gas and concentration of remifentanil. After delivery both mother and midwife answer a questionary and give their comments. Nausea, vomiting, sedation, satisfaction, mothers controll of treatment, use of pca-pumpe,dizziness, if the remifentanil dose were sufficient, amnesi, what they liked-disliked and overall comment are recorded.


Condition Intervention
Labour Pain
Drug: Remifentanil

MedlinePlus related topics: Nausea and Vomiting
Drug Information available for: Remifentanil Remifentanil hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sorlandet Hospital HF:

Estimated Enrollment: 34
Study Start Date: January 2004
Estimated Study Completion Date: September 2005
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00202722

Contacts
Contact: Jan Henrik Rosland, Professor +4755979387 jhro@haraldsplass.no
Contact: Tor O. Tveit, MD +4738073608 tor.oddbjorn.tveit@sshf.no

Locations
Norway, Vest-Agder
Sorlandet sykehus HF Recruiting
Kristiansand, Vest-Agder, Norway, N-4623
Contact: Tor O. Tveit, MD     +4738073608     tor.oddbjorn.tveit@sshf.no    
Contact: Arthur B. Halvorsen, MD     +4738075333     arthur.halvorsen@sshf.no    
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Principal Investigator: Tor O. Tveit, MD employed
Study Chair: Jan H. Rosland, Professor part time
  More Information

Publications:
Study ID Numbers: 70310
Study First Received: September 12, 2005
Last Updated: December 22, 2005
ClinicalTrials.gov Identifier: NCT00202722  
Health Authority: Norway: Drug Administration

Study placed in the following topic categories:
Signs and Symptoms
Remifentanil
Labor Pain
Neurologic Manifestations
Pain

Additional relevant MeSH terms:
Anesthetics, Intravenous
Nervous System Diseases
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 15, 2009