Comparison of pain score and satisfaction with wound healing in two groups receiving intravenous ibuprofen infusion and placebo in emergency department
The purpose of this study was to compare the pain and satisfaction of patients with wound healing in two groups receiving intravenous ibuprofen infusion and placebo.
Design
The design of the study is a randomized clinical trial. The randomization method is blocked. The sample size for each study group is 75.
Settings and conduct
In this research, all patients referred to the to the Emergency Department of Shohada-e- Haftome tir Hospital who are with skin laceration with a minimum wound length of 2 cm, included in the study. Patients will be randomly divided into two groups based on 10 blocks. A total of 150 patients will be examined. All patients and data analyzers will be blind.
Participants/Inclusion and exclusion criteria
All patients referred to the Emergency Department of Shohada-e- Haftome tir Hospital who are wounded and over the fifteen years old and under the seventy five years old are enrolled.
Inclusion criteria: Patients with skin laceration with a minimum wound length of 2 cm.
Exclusion criteria: Patients with ischemic heart disease.
Patients with decreased consciousness.
Patients Burning by Animals.
Intervention groups
In the intervention group, before the wound healing, 800 mg ibuprofen in 200 ml of normal saline will be injected, and in the control group, 200 ml normal saline without medication will be injected.
Main outcome variables
The severity of the patient's pain before the injection; the severity of the patient's pain after the injection; patient satisfaction before wound healing; patient satisfaction during wound healing; patient satisfaction after wound healing.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120613010017N8
Registration date:2018-11-28, 1397/09/07
Registration timing:prospective
Last update:2018-11-28, 1397/09/07
Update count:0
Registration date
2018-11-28, 1397/09/07
Registrant information
Name
Hamed Basir Ghafouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 9233
Email address
h-basirghafouri@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pain score and satisfaction with wound healing in two groups receiving intravenous ibuprofen infusion and placebo in emergency department
Public title
Comparison of pain score and satisfaction with wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with skin laceration with a minimum wound length of 2 cm
Exclusion criteria:
Patients with ischemic heart disease
Patients with decreased consciousness
Patients who are bitten by animals
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method is used. For this purpose, we formed blocks with 10 person. In each block, 5 individuals will be in intervention group and 5 will be in control group. A total of 15 blocks will be considered for sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the study will be blinded of the type of received intervention. Data analyzer will be blinded of the type of intervention received by patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-06-22, 1396/04/01
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9511307013
Health conditions studied
1
Description of health condition studied
Wound repair
ICD-10 code
T81.33
ICD-10 code description
Disruption of traumatic injury wound repair
Primary outcomes
1
Description
The severity of the patient's pain
Timepoint
Before and After injection
Method of measurement
Questionnaire
2
Description
Patient satisfaction
Timepoint
Before wound healing, during wound healing and After wound healing
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of 800 mg ibuprofen in 200 ml of normal saline
Category
Treatment - Drugs
2
Description
Control group: Injection 200 ml normal saline without medicine