Evaluation of the effect of intravenous fentanyl plus midazolam on wound repair score of second degree burn wounds of trunk: a Randomized clinical trial
Morphine and µ agonists have reduced inflammatory mediators and accelerated epithelialization and wound closure in animal and human wound model studies. This randomized clinical trial evaluates wound healing with sedating patients by usage of fentanyl plus midazolam, compared to routine morphine in Shahid Sadoughi burn hospital in Yazd, Iran. Patients aged 15-55 years old with second degree burn who need daily dressing change are enrolled in the study in their second day of admission till at least 65 patients get enrolled in each group. Patients with comorbidities, immune deficiency or opiates addiction history are excluded. Patients are allocated to intervention or placebo group randomly. All patients receive 5 mg morphine sulfate 15 minutes before changing wound dressing. Three minutes before dressing change, intervention group receive 5 µg Fentanyl plus 2 mg Midazolam and control group receive 5 cc sterilized water. The biggest wound of patient which is larger than 5 percent will be evaluated daily in first week and then every 2 weeks till 3 months according to Vancouver score, clinical healing time and wound infection. Pain score will be evaluated using Visual Analog Scale, 5 minutes before and after dressing change in both groups. Patients, nurses who change the dressing and data collector and analyzers are blind to allocation.
General information
Acronym
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IRCT registration information
IRCT registration number:IRCT2016051811921N1
Registration date:2016-06-17, 1395/03/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-17, 1395/03/28
Registrant information
Name
Sima Valizadeh
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3823 3040
Email address
valizade@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yazd Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of intravenous fentanyl plus midazolam on wound repair score of second degree burn wounds of trunk: a Randomized clinical trial
Public title
The effect of fentanyl plus midazolam injection during wound dressing change on the healing of burn wounds
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 16 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Central building of Yazd Shahid Sadoughi University of Medical Sciences, Bahonar Square
City
Yazd
Postal code
Approval date
2015-03-14, 1393/12/23
Ethics committee reference number
17/1/3315/پ
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
(T20-T25)
ICD-10 code description
Burns and corrosions of external body surface
Primary outcomes
1
Description
wound repair score
Timepoint
every 2 weeks from week zero till 12th week
Method of measurement
Vancover score
2
Description
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 outcomes
1
Description
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
2
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi burn hospital
Full name of responsible person
Edalatkhah MD
Street address
Moallem Alley, Shahid Paknejad Street, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Amir Hooshang Mehrparvar
Street address
Central building of Yazd Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Yazd
Grant name
-----
Grant code / Reference number
-----
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Yazd Shahid Sadoughi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Sima Valizadeh
Position
Researcher
Other areas of specialty/work
Street address
Central building of Yazd Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35338233040
Fax
Email
valizade@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Abbas Edalatkhah MD
Position
Emergency medicine Sprcialist
Other areas of specialty/work
Street address
Central building of Yazd Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 3823 3040
Fax
Email
abbas_edalatkhah@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Sima Valizadeh, MD
Position
Researcher, Medical Doctor
Other areas of specialty/work
Street address
Central building of Yazd Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 3823 3040
Fax
Email
valizade@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)