Effect of Fentanyl on Pain Severity and Duration of Labor

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Nahid Jahani Shoorab, Mashhad University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01648595

First received: July 17, 2012

Last updated: July 23, 2012

Last verified: January 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	July 17, 2012
Last Updated Date	July 23, 2012
Start Date ^ICMJE	January 2006
Primary Completion Date	August 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 23, 2012)	decrease pain and duration of the active phase considerably. [ Time Frame: up to 8 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01648595 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Fentanyl on Pain Severity and Duration of Labor
Official Title ^ICMJE	Principal Investigator
Brief Summary	Background: There are two methods of pharmacologic and non- pharmacologic for reducing pain of delivery. It is necessary to be known effect of these drugs on the mother and fetus during labor adverse. Therefore, the purpose of this study was determination of effect of Fentanyl intravenously on pain severity during the active phase of labor.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Decrease Labor Pain
Intervention ^ICMJE	Drug: Fentanyl In case group, 50 micrograms fentanyl was prescribed in two doses with an interval of 1 hour after being diluted in 4 cc normal saline
Study Arm (s)	Experimental: Fentanyl In case group, 50 micrograms fentanyl was prescribed in two doses with an interval of 1 hour. In control group was not intervention. Intervention: Drug: Fentanyl No Intervention: Without Fentanyl The control group did not receive Fentanyl.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	70
Completion Date	September 2006
Primary Completion Date	August 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: multiparas pregnant women (gravid 2-7), term singleton pregnancy, cephalic presentation, low risk pregnancy with no history of drug tolerance (addiction), medical and mental diseases. Exclusion Criteria: Respiratory rate ≤ 8 or maternal bradycardia (pulse rate less than 60).
Gender	Female
Ages	21 Years to 37 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01648595
Other Study ID Numbers ^ICMJE	Effect of Fentanyl
Has Data Monitoring Committee	Yes
Responsible Party	Nahid Jahani Shoorab, Mashhad University of Medical Sciences
Study Sponsor ^ICMJE	Mashhad University of Medical Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mashhad University of Medical Sciences
Verification Date	January 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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