Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

Effect of Fentanyl on Pain Severity and Duration of Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01648595
Recruitment Status : Terminated
First Posted : July 24, 2012
Last Update Posted : July 24, 2012
Information provided by (Responsible Party):
Nahid Jahani Shoorab, Mashhad University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Decrease Labor Pain Drug: Fentanyl Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Principal Investigator
Study Start Date : January 2006
Primary Completion Date : August 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
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

No Intervention: Without Fentanyl
The control group did not receive Fentanyl.

Primary Outcome Measures :
  1. decrease pain and duration of the active phase considerably. [ Time Frame: up to 8 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female

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).

Layout table for additonal information
Responsible Party: Nahid Jahani Shoorab, Faculty of Midwifery, Mashhad University of Medical Sciences Identifier: NCT01648595    
Other Study ID Numbers: Effect of Fentanyl
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: January 2006
Keywords provided by Nahid Jahani Shoorab, Mashhad University of Medical Sciences:
duration of the active phase
pain severity
Additional relevant MeSH terms:
Layout table for MeSH terms
Labor Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General