]>

IRCT2016051811921N1 IRCT 2016-06-17 Vice chancellor for research of Yazd Shahid Sadoughi University of Medical Sciences 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 2015-09-23 anticipated 130 Complete https://irct.ir/trial/12103 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Every Patient is allocated to group one or two by using a sealed pocket.The code of 1 or 2 will be written on patient's questionnaire. Drugs 1 and 2 is prepared in completely the same syringes by another colleague.The patient receives drug 1 or 2 according to his/her group. None of the colleagues (the nurse who change the dressing, the one who follow up and collect data, the one who analyze the data) nor the patients are informed about coding. That one who prepares the syringes does not take part in changing the wound dressing, collection or analyzing the data. 2-3 Burn. 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 patients receive 5 mg morphine sulfate intravenously, 10-15 minutes before changing of wound dressing. Intervention will be performed daily for 7 days. Cardiac monitoring and pulse oximetery will be done for all patients. Resuscitation unit will be prepared for each patient. The follow up will be as the same for both groups. Intervention 2: 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 patients are cardiac monitored and also by pulse oximeter. resuscitation unit will be prepared for every patient.Intervention by placebo will be done daily for7 days. The follow up will be the same for both groups.

public Sima Valizadeh

Central building of Yazd Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran

Yazd Iran (Islamic Republic of) +98 35338233040 valizade@ssu.ac.ir Yazd Shahid Sadoughi University of Medical Sciences scientific Abbas Edalatkhah MD

Central building of Yazd Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran

Yazd Iran (Islamic Republic of) +98 35 3823 3040 abbas_edalatkhah@yahoo.com Yazd Shahid Sadoughi University of Medical Sciences Iran (Islamic Republic of) 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 16 years 55 years Both (T20-T25) Burns and corrosions of external body surface 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 5 mg morphine sulfate intravenously, 10-15 minutes before changing of wound dressing. Intervention will be performed daily for 7 days. Cardiac monitoring and pulse oximetery will be done for all patients. Resuscitation unit will be prepared for each patient. The follow up will be as the same for both groups. 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 patients are cardiac monitored and also by pulse oximeter. resuscitation unit will be prepared for every patient.Intervention by placebo will be done daily for7 days. The follow up will be the same for both groups. 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. 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. Vice chancellor for research of Yazd Shahid Sadoughi University of Medical Sciences Approved 2015-03-14 Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences Central building of Yazd Shahid Sadoughi University of Medical Sciences, Bahonar Square Yazd Iran (Islamic Republic of)