The effect of fentanyl plus midazolam injection during wound dressing change on the healing of burn wounds
Phase 2
- Conditions
- Burn.Burns and corrosions of external body surface(T20-T25)
- Registration Number
- IRCT2016051811921N1
- Lead Sponsor
- Vice chancellor for research of Yazd Shahid Sadoughi University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Inclusion Criteria:
Patients aged 16-55 years with second degree thermal burn; require daily dressing change; being in second day of admission; having at least one wound larger than 5 % of body surface area; signing informed consent.
Exclusion Criteria
affected by chronic disease (Diabetes mellitus, cardiovascular disease, Hepatic disease, Renal disease); Immune deficiency( corticosteroid, chemotherapy); history of anaphilaxys to sedation drugs, Opiates, benzodiazepines; difficult airway according to mallampati score; history of opiates addiction
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound repair score. Timepoint: every 2 weeks from week zero till 12th week. Method of measurement: Vancover score.;Time to healing. Timepoint: every 2 weeks from week 1 till 12th week. Method of measurement: According to clinical judgment of plastic surgeon regarding discharge, pain or redness of the burned area. When plastic surgeon confirms clinical healing, that time is documented as the healing time.
- Secondary Outcome Measures
Name Time Method Pain score. Timepoint: 5 minutes before and after changing dressing every 2 weeks from week zero till 12th week. Method of measurement: Visual Analogue Scale.;Wound infection. Timepoint: daily in first week then on 14th day. Method of measurement: According to clinical judgment of plastic surgeon regarding discharge and erythema of wound.