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Trial record 6 of 1046 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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Labour Pain
Satisfaction
Adverse Effects
Intervention Drug: Remifentanil
Enrollment 41
Recruitment Details Recruited at arrival to the Labour department
Pre-assignment Details  
Arm/Group Title Effect and Side Effects of Remifentanil
Hide Arm/Group Description Analgesic efficacy and side offects of remifentanil during labour and delivery
Period Title: Overall Study
Started 41
Completed 41
Not Completed 0
Arm/Group Title Women in Labour Given Remifentanil Analgesia
Hide Arm/Group Description Administration of remifentanil analgesia startet with cervical dilatation > 4 cm
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 41 participants
27
(20 to 33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
41
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Norway Number Analyzed 41 participants
41
1.Primary Outcome
Title Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)
Hide Description 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.
Time Frame From start with remifentanil treatment until delivery, up to 8 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title Remifentanil
Hide Arm/Group Description:

Pain scores

Satisfaction

Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: millimeters
47  (20.2)
2.Secondary Outcome
Title Patient Satisfaction
Hide Description 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.
Time Frame From start of remifentanil treatment until delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Satisfaction With Remifentanil Analgesia
Hide Arm/Group Description:
Patient satisfaction with remifentanil pain relief by use of questionnaire (within 24-hours after delivery)
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Participants
37
Time Frame From start of remifentanil analgesia until delivery
Adverse Event Reporting Description Continuous monitoring of oxygen saturation
 
Arm/Group Title Maternal Oxygen Desaturation
Hide Arm/Group Description Oxygen saturation lower than 92% during labour and delivery
All-Cause Mortality
Maternal Oxygen Desaturation
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Maternal Oxygen Desaturation
Affected / at Risk (%) # Events
Total   11/41 (26.83%)    
Respiratory, thoracic and mediastinal disorders   
Oxygen saturation lower than 92%  [1]  11/41 (26.83%)  11
Indicates events were collected by systematic assessment
[1]
Oxygen saturation lower than 92% during labour and delivery, administration of supplemental oxygen
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Maternal Oxygen Desaturation
Affected / at Risk (%) # Events
Total   22/41 (53.66%)    
Nervous system disorders   
Maternal sedation  [1]  22/41 (53.66%)  22
Indicates events were collected by systematic assessment
[1]
The participants evaluation of sedation level during remifentanil treatment by use of questionnaire within 24 hours after delivery (1=no sedation, 5=very sedated).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tor Tveit
Organization: Sorlandet Hospital HF
Phone: +4738073608
EMail: tor.tveit@sshf.no
Layout table for additonal information
Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT00202722     History of Changes
Other Study ID Numbers: SSHF812310
First Submitted: September 12, 2005
First Posted: September 20, 2005
Results First Submitted: March 16, 2010
Results First Posted: June 23, 2014
Last Update Posted: June 23, 2014