Status:
NOT_YET_RECRUITING
Distraction As Multimodal Pain Management
Lead Sponsor:
Radboud University Medical Center
Conditions:
Pain, Acute
Burns
Eligibility:
All Genders
5-12 years
Phase:
NA
Brief Summary
A randomized controlled trial will be performed at the Ngwelezana Hospital, Empangeni, South Africa. Paediatric patients between the age of 5-12 years with minor and superficial partial thickness burn...
Eligibility Criteria
Inclusion
- Pediatric patients between the age of 5 and 12 years old with burn injuries requiring dressing changes in the outpatient clinic, who in regular practice (non-research setting) would not receive any analgesics other than paracetamol or a non-steroidal anti-inflammatory drug (NSAID);
- Superficial partial thickness burns \< 5% TBSA (total body surface area) at the time of injury
- Only the first change of dressing is included
Exclusion
- Patients who underwent split skin grafts for their burns;
- Patients on sedatives or anti-epileptics;
- The use of pain-relieving medication other than paracetamol or NSAIDs;
- If it is the patient's second presentation to Ngwelezana hospital's outpatient burns department
- Painful additional injuries other than the burn injury;
- Physical or mental impairments which make it impossible to adequately comply with the trial protocol. For example, visual impairments, impaired ability to communicate, psychological comorbidities, and burns that limit the use of a kaleidoscope (facial burns or burns to both hands)
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT06591195
Start Date
October 1 2024
End Date
October 1 2026
Last Update
September 19 2024
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