Back to resultsParacetamol Hypothermia Children
Primary Purpose
Safety Issues
Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Paracetamol
Sponsored by
About this trial
This is an interventional other trial for Safety Issues
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
- Saint Georges hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Temperature comparison
No change
Arm Description
Outcomes
Primary Outcome Measures
Temperature variation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04608669
Brief Title
Paracetamol Hypothermia Children
Official Title
Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint George Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Temperature comparison
Arm Type
Other
Arm Title
No change
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
Give paracetamol or placebo and compare temperature
Primary Outcome Measure Information:
Title
Temperature variation
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Facility Information:
Facility Name
Saint Georges hospital
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
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Paracetamol Hypothermia Children
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