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Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal Morphine Induced Pruritus After Cesarean Section

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00890942
First received: April 26, 2009
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  Purpose

The purpose of this study is to determine whether intramuscular naloxone 0.4mg. is effective in prophylaxis of intrathecal morphine induced pruritus after cesarean section.


Condition Intervention
Morphine Adverse Reaction
 Drug: naloxone
Drug: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • efficacy of intrathecal naloxone 0.4mg. in prophylaxis of intrathecal morphine induced pruritus after cesarean section [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: May 2009
Study Completion Date: May 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: naloxone Drug: naloxone
naloxone 0.4mg.(1 ml) intramuscular
Other Name: narcan
Placebo Comparator: normal saline Drug: normal saline
normal saline 1 ml IM
Other Name: normal saline

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient schedule for cesarean section ASA class 1

Exclusion Criteria:

  • have contraindication for spinal block
  • complicated pregnancy
  • have history of drug abuse during pregnancy
  • obesity BMI>35kg./m2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890942

Locations
Thailand
Anesthesiology department, Siriraj Hospital, Mahidol University
Bangkok, Thailand
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Tachawan Jirativanont, MD Anesthesiology department ,Siriraj hopital
  More Information

No publications provided

Responsible Party: Tachawan Jirativanont, Mahidol University
ClinicalTrials.gov Identifier: NCT00890942     History of Changes
Other Study ID Numbers: Si146/2009
Study First Received: April 26, 2009
Last Updated: July 22, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
pruritus
intrathecal morphine

Additional relevant MeSH terms:
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013