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

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ClinicalTrials.gov Identifier: NCT00890942
Recruitment Status : Completed
First Posted : April 30, 2009
Last Update Posted : July 25, 2011
Sponsor:
Information provided by:
Mahidol University

Brief Summary:
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 or disease Intervention/treatment Phase
Morphine Adverse Reaction Drug: naloxone Drug: normal saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal
Study Start Date : May 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. efficacy of intrathecal naloxone 0.4mg. in prophylaxis of intrathecal morphine induced pruritus after cesarean section [ Time Frame: 24 hour ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Tachawan Jirativanont, Mahidol University
ClinicalTrials.gov Identifier: NCT00890942     History of Changes
Other Study ID Numbers: Si146/2009
First Posted: April 30, 2009    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011

Keywords provided by Mahidol University:
pruritus
intrathecal morphine

Additional relevant MeSH terms:
Morphine
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists