A RCT to test the analgesic efficacy of topical morphine on minor and partial thickness burns in A&E - A&E burns dresing study

Phase 1

• Conditions: Minor superficial and partial thickness burns <5% body surface area.

• Registration Number: EUCTR2005-003285-42-GB
• Lead Sponsor: Portsmouth Institution Medicine, Health & Social Care, Portsmouth University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-24
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

- Over 7 years of age and deemed competent to give own informed consent.
- If aged 7-15 inclusive must be accompanied by adult with parental responsibility.
- Attending A&E with a minor superficial or partial thickness burn that does not require the patient to be admitted to hospital or transferred to a burns specilaist, as per the National Burn Inury Referral Guidelines.
- Burn must be caused by hot water/steam, a hot surface of sunburn.
- Burn must be less than 8 hours old at first attendance to A&E.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Minors aged 7-15 years unaccompanied by adult with parental responsibility.
- Persons unable to give their own informed consent.
- Burns to the head, neck, face & genitalia.
- Electrical and chemical burns.
- Pregnant women.
- Persons with other injuries.
- Persons with altered perceptions to pain due to pathophysiology of disease, alcohol or drugs.
- Patients requiring a stat dose of opiod-based medication to control their pain on arrival to A&E.
- Persons regularly prescribed opiod-based medications.
- Persons who appear to be under the influence of alcohol or illicit drugs at time of attendance to A&E
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Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To test the analgesic efficacy of morphine when applied topically to a burn.;Secondary Objective: To compare the comfort of a dressing containing morphine and intrasite gel, with an intraiste gel only or standard Jelonet dressing when applied to a burn;Primary end point(s): To obtain 4 pain score ratings and one comfort rating from 63 particpants in 6 months