Protocol summary

Study aim
Investigating the analgesic effect of three different drugs to control the pain of burn patients, and ultimately using the most effective drug with the least side effects.
Design
78 burn patients randomly will be divided into three groups of 26 people on the first day of visiting emergency room; Systematic randomization method is created using the randomization command in the Excel program (Random Between).The randomization is such that the first person is placed in group A, the second person is in group B, and the third one is in group C, and in the same way, the next patient is in group A and... After the injection of the medicine, the intensity of the pain will be recorded in 15, 30, 45 and 60 minutes. The reduction of the patient's pain by more than 3 points means the beginning of response to the treatment.
Settings and conduct
A clinical trial & double-blind study, so that the patient and the nurse don't know the type of medicine received. The study is carried out in the emergency department of Taleghani Hospital in Ahvaz on burn patients.
Participants/Inclusion and exclusion criteria
Patients from the age group of 18-55 years with 2nd and 3rd degree burns, burn extent of 30-60% and pain intensity of at least 6 out of 10 based on the NRS criteria are included in the study. Patients who have a history of allergy to any of the above drugs, addicts, pregnant women and people with a low level of consciousness are excluded.
Intervention groups
We give 0.1mg/kg of morphine to group A , 1.5mcg/kg fentanyl to group B and 0.75mg/kg pethidine to the next one.
Main outcome variables
At the end of the study, the obtained pain numbers are evaluated and compared based on the NRS criteria; Another variable that is important to us is the possible side effects of the drug within an hour after the injection, which we must monitor the patient carefully.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230704058673N2
Registration date: 2023-09-02, 1402/06/11
Registration timing: prospective

Last update: 2023-09-02, 1402/06/11
Update count: 0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
mojtaba sasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3392 4155
Email address
sasani-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparison between antianalgesic effect and side effects of Fentanyl , Morphine and Pethidine for burn injury at first hour admission in hospital
Public title
Antianalgesic effect and side effects of Fentanyl , Morphine and Pethidine for burn injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients from 18-55 years old with 2-3th grade of burning with extent of burn 30-60% pain degree 6-10 according to NRS
Exclusion criteria:
pregnant women allergy to mentioned opioids addicts GCS<15
Age
From 18 years old to 55 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Systematic randomization method is used for random allocation. The randomization is such that the first person is placed in group A, the second person in group B and the third person in group C, and in the same way the next references are in group A and...
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be done under circumstances which the patient and the nurse don't have information about the group of antianalgesic and they just know the A , B ,C group.
Placebo
Not used
Assignment
Parallel
Other design features
We record the pain degree after 15-30-45 & 60 minutes.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Jondishapur University of Medical Sciences
Street address
Farvardin Avn , Ahvaz Jondishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2022-11-30, 1401/09/09
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.136

Health conditions studied

1

Description of health condition studied
burning
ICD-10 code
T20-T25
ICD-10 code description
Burns and corrosions of external body surface, specified by site

Primary outcomes

1

Description
Pain intensity in burn patients
Timepoint
Measurement of pain intensity at the beginning of the study (before the intervention) and 15, 30, 45 and 60 minutes after the intervention
Method of measurement
NRS criteria

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1:one dose of 0.1 mg/kg of morphine is injected intravenously to the first group.
Category
Treatment - Drugs

2

Description
Intervention group 2: One dose of 1.5 mcg/kg of fentanyl is injected intravenously to the second group.
Category
Treatment - Drugs

3

Description
Intervention group 3: One dose of 0.75 mg/kg of pethidine is injected intravenously to the third group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Mojtaba Sasani
Street address
Hejrat sq,Padadshahr2 Ave, Taleghani Hospital
City
Ahvaz
Province
Khouzestan
Postal code
4561355
Phone
+98 61 3554 7996
Email
sasani-m@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi moghaddam
Street address
Golestan Ave,Jondishapur university
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
https://vchresearch.ajums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Sasani
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan Ave,Jondishapur University
City
Ahvaz
Province
Fars
Postal code
6135715794
Phone
+98 61 3571 5794
Email
Drsasani72363@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Sasani
Position
professor assistant
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan Ave,Jondishapaur University
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 915 512 0247
Email
Drsasani72363@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Sasani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Goletan . farvardin bolvar . goletan hospital . emergency department
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3392 4155
Fax
Email
sasani-m@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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