Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201707002421448 Date of Approval: 11/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFICACY OF KETAMINE VERSUS MORPHINE IN PAIN MANAGEMENT FOR PEADIATRIC BURNS DRESSING AT MULAGO HOSPITAL: A RANDOMISED CONTROLLED TRIAL
Official scientific title EFFICACY OF KETAMINE VERSUS MORPHINE IN PAIN MANAGEMENT FOR PEADIATRIC BURNS DRESSING AT MULAGO HOSPITAL: A RANDOMISED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Burns are a globally account for 0.265 Million deaths annually with majority in low-middle income countries. The World Health Organization ranks burns as the fifth commonest cause of non-fatal childhood injuries and 11th leading cause of mortality in those under nine years. A study done in Uganda by Nakitto et al, showed that burn injuries accounted for 11% of all childhood injuries. Burn injury pain can be classified as background, breakthrough or procedural pain. Pain due to wound dressing is regarded as procedural pain. Children described wound dressing pain as ¿the most painful thing they had ever done and that they didn¿t know the human body could experience so much pain¿. Oral morphine which is commonly used has numerous limitations (policy regulations, respiratory depression, unpredictable onset time and hyperalgesia with repeated use). Ketamine is accessible, cheap, and titratable to effect. It has analgesic, sedative, anti-inflammatory and amnestic effects which would alleviate the psychosocial detriments associated with burn pain. General objective. To compare the efficacy and safety of oral ketamine 10 mg/kg as an analgesic versus oral morphine 1mg/kg in paediatric patients 15years and below with burns undergoing dressing change at Mulago Hospital burns unit. Specific objectives; 1.To determine paediatric burns patients¿ pain scores when using oral ketamine versus oral morphine during dressing change using the Visual Analog Scale (VAS) or Children¿s Hospital of Eastern Ontario Pain Scale (CHEOPS). 2.To determine the adverse effects of using oral ketamine versus oral morphine in the paediatric patients with burns undergoing dressing change at Mulago hospital. 3.To determine the incidence of sedation when using ketamine or morphine for pain control during dressing change.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Paediatrics,pain in burns dressing change
Sub-Disease(s) or condition(s) being studied
Purpose of the trial ketamine or morphine
Anticipated trial start date 01/08/2017
Actual trial start date
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised simple randomisation using a randomisation table created by a computer software program. sequentially numbered sealed opaque envelopes Masking/blinding used
Crossover: all participants receive all interventions in different sequence during study Randomised simple randomisation using a randomisation table created by a computer software program. sequentially numbered sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group oral ketamine 10mg/kg 120 minutes ketamine will be premixed in oral paracetamol to blunt the taste 44 Active-Treatment of Control Group
Control Group oral moprhine 1mg/kg 4 hours The liquid formulation will be premixed in paracetamol syrup. 44 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-All children aged 15 years and below with burns scheduled for bedside change of dressing. -Children with burns requiring more than one dressing change at least 48 hours apart -Altered mental status that hinders communication for older children or movement for younger children. -Lower than 90% oxygen saturation on initial assessment. -History of allergic reactions to either of the drugs. -Children already on sedatives or anticonvulsants. 0 Year(s) 15 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 26/06/2017 school of medicine research and ethics commitee
Ethics Committee Address
Street address City Postal code Country
mulago hill kampala 7062 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain score Pre- procedure Ten minute interval during the procedure.
Secondary Outcome incidence of adverse events 5 minute intervals. 2 hours post- procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mulago National Referral Hospital burns unit mulago Kampala p.o box 7211 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Patience Atumanya mulago Kampala Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Patience Atumanya mulago Kampala Uganda University
COLLABORATORS
Name Street address City Postal code Country
Peter K Agaba mulago Kampala Uganda
Ekwaro. A. Obuku mulago Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Patience Atumanya atumanyap@gmail.com 0774314427 mulago
City Postal code Country Position/Affiliation
kampala p.o ox 7062 Uganda student- Makerere University, College of Health Sciences
Role Name Email Phone Street address
Public Enquiries Patience Atumanya atumanyap@gmail.com 0774314427 mulago
City Postal code Country Position/Affiliation
kampala Uganda student, Makerere University, College of Health Sciences
Role Name Email Phone Street address
Scientific Enquiries Patience Atumanya atumanyap@gmail.com 0774314427 mulago
City Postal code Country Position/Affiliation
kampala Uganda student, Makerere University, College of Health Sciences
REPORTING
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