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The effect of fentanyl plus midazolam injection during wound dressing change on the healing of burn wounds

Evaluation of the effect of intravenous fentanyl plus midazolam on wound repair score of second degree burn wounds of trunk: a Randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016051811921N1
Enrollment
130
Registered
2016-06-17
Start date
2015-09-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn. Burns and corrosions of external body surface

Interventions

Intervention 1: Intervention group: 3 minutes before daily changing the wound dressing, 50 microgram Fentanyl (Dorsa Darou) plus 2 miligram Midazolam (Dorsa Darou) will be infused intravenously .All
Treatment - Drugs
Placebo
Intervention group: 3 minutes before daily changing the wound dressing, 50 microgram Fentanyl (Dorsa Darou) plus 2 miligram Midazolam (Dorsa Darou) will be infused intravenously .All patients receive
Placebo group: 5 cc strilled water in the same 5 cc syringe will be infused intravenously. All patients receive 5 mg morphine sulfate intravenously 10-15 minutes before changing dressing . All pati

Sponsors

Vice chancellor for research of Yazd Shahid Sadoughi University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 55 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSima Valizadeh

Yazd Shahid Sadoughi University of Medical Sciences

valizade@ssu.ac.ir+98 35338233040

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026