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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 18 April 2016
Main ID:  NCT02456142
Date of registration: 25/05/2015
Prospective Registration: Yes
Primary sponsor: Makerere University
Public title: CAUDAL BUPIVACAINE VERSUS INTRAVENOUS MORPHINE ON TIME TO FIRST ANALGESIC REQUIREMENT CaBuMorph
Scientific title: EFFECT OF CAUDAL BUPIVACAINE VERSUS INTRAVENOUS MORPHINE ON TIME TO FIRST ANALGESIC REQUIREMENT IN PEDIATRIC SURGICAL PATIENTS; A RANDOMISED CONTROLLED TRIAL.
Date of first enrolment: July 2015
Target sample size: 70
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02456142
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Uganda
Contacts
Name:     EZRA MUGISHA, MBChB
Address: 
Telephone:
Email:
Affiliation:  makerere university college of health sciences department of anesthesia
Key inclusion & exclusion criteria

Inclusion Criteria:

- All American Society of Anesthesia (ASA )I and II patients aged less than 8years
undergoing elective abdominal perineal and lower limb orthopedic surgery

Exclusion Criteria:

- Known hypersensitivity to opioids Known hypersensitivity to local anesthetics



Age minimum: N/A
Age maximum: 8 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Post Operative Pain
Intervention(s)
Drug: intravenous morphine
Drug: caudal bupivacaine
Primary Outcome(s)
time to first analgesic requirement [Time Frame: 24 hours]
Post- operative pain scores of the patients using age appropriate scales. [Time Frame: 24 hours]
Secondary Outcome(s)
Adverse effects reactions of the intravenous morphine analgesia and caudal analgesia [Time Frame: 24 hours]
Secondary ID(s)
206005358
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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