Back to resultsEfficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal Morphine Induced Pruritus After Cesarean Section
Primary Purpose
Morphine Adverse Reaction
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
naloxone
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Morphine Adverse Reaction focused on measuring pruritus, intrathecal morphine
Eligibility 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
Sites / Locations
- Anesthesiology department, Siriraj Hospital, Mahidol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
naloxone
normal saline
Arm Description
Outcomes
Primary Outcome Measures
efficacy of intrathecal naloxone 0.4mg. in prophylaxis of intrathecal morphine induced pruritus after cesarean section
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00890942
Brief Title
Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal Morphine Induced Pruritus After Cesarean Section
Official Title
Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morphine Adverse Reaction
Keywords
pruritus, intrathecal morphine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
naloxone
Arm Type
Experimental
Arm Title
normal saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
naloxone
Other Intervention Name(s)
narcan
Intervention Description
naloxone 0.4mg.(1 ml) intramuscular
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
normal saline 1 ml IM
Primary Outcome Measure Information:
Title
efficacy of intrathecal naloxone 0.4mg. in prophylaxis of intrathecal morphine induced pruritus after cesarean section
Time Frame
24 hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tachawan Jirativanont, MD
Organizational Affiliation
Anesthesiology department ,Siriraj hopital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesiology department, Siriraj Hospital, Mahidol University
City
Bangkok
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal Morphine Induced Pruritus After Cesarean Section
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