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

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT00890942
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
12
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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
N/A

Study Design

Study Type:
Interventional
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 1, 2009
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: naloxone

Drug: naloxone
naloxone 0.4mg.(1 ml) intramuscular
Other Names:
  • narcan

    		•
    Placebo Comparator: normal saline

    Drug: normal saline
    normal saline 1 ml IM

    Outcome Measures

    Primary Outcome Measures

    1. efficacy of intrathecal naloxone 0.4mg. in prophylaxis of intrathecal morphine induced pruritus after cesarean section [24 hour]

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 Anesthesiology department, Siriraj Hospital, Mahidol University Bangkok Thailand

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Tachawan Jirativanont, MD, Anesthesiology department ,Siriraj hopital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00890942
    Other Study ID Numbers:
    • Si146/2009
    First Posted:
    Apr 30, 2009
    Last Update Posted:
    Jul 25, 2011
    Last Verified:
    Jul 1, 2011
    Keywords provided by , ,
    pruritus
    intrathecal morphine
    Additional relevant MeSH terms:
    Pruritus
    Naloxone

    Study Results

    No Results Posted as of Jul 25, 2011