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Trial record 6 of 982 for:    scale | Norway

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

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ClinicalTrials.gov Identifier: NCT00202722
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Labour Pain Satisfaction Adverse Effects Drug: Remifentanil Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remifentanil as Analgesia for Labour Pain
Study Start Date : January 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Remifentanil IVPCA
Bolus dose steps of 0.15 microgr/kg, with a 2-min lock-out time
Drug: Remifentanil
Intravenous patient controlled analgesia (ivpca) during labour
Other Name: Ultiva




Primary Outcome Measures :
  1. Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain) [ Time Frame: 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 :
  1. Patient Satisfaction [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202722


Locations
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Norway
Sorlandet sykehus HF
Kristiansand, Vest-Agder, Norway, N-4623
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
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Study Chair: Jan H. Rosland, Professor part time

Publications:
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Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00202722     History of Changes
Other Study ID Numbers: SSHF812310
First Posted: September 20, 2005    Key Record Dates
Results First Posted: June 23, 2014
Last Update Posted: June 23, 2014
Last Verified: May 2014

Keywords provided by Sorlandet Hospital HF:
Remifentanil, parenteral opioids, obstetric analgesia, IVPCA

Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents