Effect of Fentanyl on Pain Severity and Duration of Labor

Decrease Labor Pain Clinical Trial

Official title:

Principal Investigator

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01648595
• Other study ID #: Effect of Fentanyl
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: July 17, 2012
• Last updated: July 23, 2012
• Start date: January 2006
• Est. completion date: September 2006

Study information

• Verified date: January 2006
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: September 2006
• Est. primary completion date: August 2006
• Gender: Female
• Age group: 21 Years to 37 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Decrease Labor Pain
• Labor Pain

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease pain and duration of the active phase considerably.		up to 8 months	No