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Sorlandet Hospital HF |
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Information provided by: | Sorlandet Hospital HF |
ClinicalTrials.gov Identifier: | NCT00202722 |
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 |
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Labour Pain |
Drug: Remifentanil |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.
Contact: Jan Henrik Rosland, Professor | +4755979387 | jhro@haraldsplass.no |
Contact: Tor O. Tveit, MD | +4738073608 | tor.oddbjorn.tveit@sshf.no |
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 |
Principal Investigator: | Tor O. Tveit, MD | employed |
Study Chair: | Jan H. Rosland, Professor | part time |
Study ID Numbers: | 70310 |
Study First Received: | September 12, 2005 |
Last Updated: | December 22, 2005 |
ClinicalTrials.gov Identifier: | NCT00202722 |
Health Authority: | Norway: Drug Administration |
Signs and Symptoms Remifentanil Labor Pain Neurologic Manifestations Pain |
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 |