Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
44 participants
INTERVENTIONAL
2021-03-01
2021-11-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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GROUP A
Group A will receive rectal ketamine(Ket)
GROUP A
Rectal Ketamine will be administered at 6 mg/kg and with a rectal nozzle it's infused through the rectum. The rectal ketamine will be administered after scoring pain just before the start of the procedure and then about 15 minutes later the procedure will start when the patient has achieved a nystagmus.
GROUP B
Group B will receive only traditional standard of care protocols.
GROUP B
The tradition standard protocols involve the use of 0.3mg/kg of oral morphine about an hour before the start of the procedure before the start of the procedure to allow for the onset of action of oral morphine for every single procedure in this arm.
Interventions
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GROUP A
Rectal Ketamine will be administered at 6 mg/kg and with a rectal nozzle it's infused through the rectum. The rectal ketamine will be administered after scoring pain just before the start of the procedure and then about 15 minutes later the procedure will start when the patient has achieved a nystagmus.
GROUP B
The tradition standard protocols involve the use of 0.3mg/kg of oral morphine about an hour before the start of the procedure before the start of the procedure to allow for the onset of action of oral morphine for every single procedure in this arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Refusal to assent to participate or parental or guardian refusal to consent in the study
* Children who require mechanical ventilation or already intubated in Intensive care unit
* Those allergic to Ketamine or its constituents
6 Months
6 Years
ALL
Yes
Sponsors
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Mbarara University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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ALICE G. ATAI, MbChB
Role: PRINCIPAL_INVESTIGATOR
Mbarara University of Science and Technology
Locations
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Mbarara Regional Referral Hospital
Mbarara, , Uganda
Mbarara Regional Referral Hospital
Mbarara, , Uganda
Countries
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Other Identifiers
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2021/ANDREW
Identifier Type: -
Identifier Source: org_study_id