Comparison of different doses of ketamine and propofol for sedation and analgesia for changing the dressing in burn patients
Design
Phase III double-blind randomized cross-over trial on 120 patients, randomization with sealed envelopes
Settings and conduct
Patients admitted to the burn ward of Payambar Azam Hospital, Bandar Abbas, not receiving surgical debridement will be included based on the inclusion and exclusion criteria. Patients will receive 1mg midazolam + 0.1-0.2 μ/kg fentanyl as premedication. They will randomly receive A or B method for the first dressing change and the other method for the second time. The outcome assessor and patients will be unaware of the drugs. Patients will undergo monitoring and pulse oximetry. Oxygen saturation, heart and respiratory rate will be assessed at 0 and 10 min after and at the end of the procedure. In case of Ramsay sedation scale (RSS)>3 in each method, 50-100 mg fentanyl will be injected. RSS will be maintained at 3-4.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 15-65 years
Second- and third-degree burns
Burn area 10-70%
Daily dressing change before skin graft in the operation room with ASA class 1-3
Ability to speak and perceive the Persian language
Exclusion criteria:
Drug addiction
Respiratory and cardiac diseases
Renal disorders
Hypersensitivity to analgesics, ketamine, and propofol
History of psychiatric disorders
History of seizure
ASA class >3
Intervention groups
Method A: first 1-2 mg/kg intravenous ketamine for induction and then every time the patient's pain was >3 based on his/her facial expression, injection of 1-3 ml propofol 10%
Method B: first a mixture of propofol and ketamine each 0.5-1 mg/kg for induction and then every time the patient's pain was >3 based on his/her facial expression, injection of 1-3 ml of the same mixture
Main outcome variables
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201210049672N2
Registration date:2022-03-19, 1400/12/28
Registration timing:registered_while_recruiting
Last update:2022-03-19, 1400/12/28
Update count:0
Registration date
2022-03-19, 1400/12/28
Registrant information
Name
Bibimona Razavi
Name of organization / entity
Hormozgan University of Medical Sciences, Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 76 3371 0370
Email address
bibimonarazavi.hums@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-04-09, 1401/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of different doses of ketamine and propofol for sedation and analgesia for changing the dressing in burn patients
Public title
Comparison of different doses of ketamine and propofol for changing the dressing in burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 15-65 years
Second- and third-degree burns
Burn area of 10-70%
Daily dressing change before skin graft in the operating room with American Society of Anesthesiologists (ASA) class 1-3
Ability to speak and perceive the Persian language
Exclusion criteria:
Drug addiction
Respiratory and cardiac diseases
Renal disorders
Hypersensitivity to analgesic drugs, ketamine, and propofol
History of psychiatric disorders
History of seizure
American Society of Anesthesiologists (ASA) class >3
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with individuals as units of randomization along with allocation concealment: 120 unclear envelopes and 120 cards with the names of the groups (A, B) will be prepared (60 cards for each group). The cards will be put into the envelopes and the envelopes will be sealed and provided to the investigator. Upon entrance of each patient to the study, the envelopes will be shuffled and one will randomly be selected. The patient will be allocated to group A or B based on the card inside the selected envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The solutions will be prepared for injection in advance by an individual not involved in the study and they will only have labels indicating the groups of the study; therefore, the patients, the investigator, the care giver, and the outcome assessor will be unaware of the injected drugs.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Imam Hossein Blvd., across from Kargaran Sports Complex, Faculty of Medicine
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2021-01-12, 1399/10/23
Ethics committee reference number
IR.HUMS.REC.1399.496
Health conditions studied
1
Description of health condition studied
Second- and third-degree burns
ICD-10 code
Z48.00
ICD-10 code description
Encounter for change or removal of nonsurgical wound dressing
Primary outcomes
1
Description
Pain intensity
Timepoint
At the end of the procedure
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Sedation
Timepoint
At the end of the procedure
Method of measurement
Ramsay Sedation Scale
2
Description
Patient satisfaction
Timepoint
At the end of the procedure
Method of measurement
Poor/moderate/good/excellent
3
Description
Surgeon satisfaction
Timepoint
At the end of the procedure
Method of measurement
Poor/moderate/good/excellent
Intervention groups
1
Description
Intervention group: First the patient will receive 1-2 mg intravenous ketamin (MFR:Sterop Co., Belgium) for induction (Each ampule contains 500 mg ketamin/10 ml; therefore, each ml contains 50 mg ketamine, which will be diluted with 4 ml distilled water). During the procedure, whenever the patient's pain score is >3 based on his/her facial expression, 1-3 ml propofol 1% will be injected (each ampule contains 200 mg propofol 1%/20 ml, DoNcKood.phar Co. Korea) in divided intravenous doses (taking 30-100 μ/kg/min as reference based on the interval between injections and the patient's weight).
Category
Treatment - Drugs
2
Description
Intervention group: Ketamine will be diluted with distilled water so that each 1 ml contains 10 mg ketamine (Each ampule contains 500 mg ketamin/10 ml; therefore, each ml contains 50 mg ketamine, which will be diluted with 4 ml distilled water). Then, equal proportions of ketamine and propofol 1% (each ampule contains 200 mg propofol 1%/20 ml) will be mixed in a 10-ml syringe so that each ml of this 0.5% ketofol 0.5% mixture contains 5 mg ketamine and 5 mg propofol. Then, first 0.5-1 mg/kg of the mixture will be injected intravenously for induction. During the procedure, whenever the patient's pain score is >3, 0.1-0.5 mg/kg of the same mixture will be injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Payambar Azam Hospital
Full name of responsible person
Bibimona Razavi
Street address
Jomhouri Eslami Blvd., Payambar Azam Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 7000
Fax
+98 76 3334 5003
Email
shmh@hums.ac.ir
Web page address
https://shmh.hums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery for Research Hormozgan University of Medical Sciences
Full name of responsible person
Teamur Aghamolaei
Street address
Imam Hossein Blvd., across from Kargaran Sports Complex
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0393
Email
teaghamolaei@gmail.com
Web page address
https://resv.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery for Research Hormozgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Bibimona Razavi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhouri Eslami Blvd., Payambar Azam Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Fax
+98 76 3334 5009
Email
bibimonarazavi.hums@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Bibimona Razavi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhouri Eslami Blvd., Payambar Azam Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
979199155
Phone
+98 76 3334 5009
Fax
+98 76 3334 5009
Email
bibimonarazavi.hums@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Bibimona Razavi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Jomhouri Eslami Blvd., Payambar Azam Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 5009
Fax
+98 76 3334 5009
Email
bibimonarazavi.hums@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD