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
  Purpose

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 Intervention Phase
Decrease Labor Pain
Drug: Fentanyl
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Principal Investigator

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • decrease pain and duration of the active phase considerably. [ Time Frame: up to 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2006
Estimated Study Completion Date: September 2006
Estimated Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 37 Years
Genders Eligible for Study:   Female
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Nahid Jahani Shoorab, Faculty of Midwifery, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01648595     History of Changes
Other Study ID Numbers: Effect of Fentanyl
Study First Received: July 17, 2012
Last Updated: July 23, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Mashhad University of Medical Sciences:
Fentanyl
analgesia
duration of the active phase
pain severity

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 18, 2014