Comparison of the effect of ketorolac and pethidine on analgesia and drug use after lower limb orthopedic surgery by spinal anesthesia
Design
The present study was a double-blind randomized clinical trial with parallel groups on 60 patients who were randomly divided into two groups by Throwing coins .
Settings and conduct
This double-blind randomized clinical trial study was performed on 60 patients who underwent lower limb orthopedic surgery (femur and tibia) in the orthopedic operating room of Peymaniyeh Hospital in Jahrom. Patients were randomly divided into two groups: pethidine and ketorolac. The study participant, the researcher, and the data collector were unaware of which group the individuals belonged to.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients are candidates for lower limb orthopedic surgery who undergo spinal anesthesia during the procedure.
Exclusion criteria: Hemodynamic instability, bradycardia or tachycardia, and other complications whose continued presence in the study poses potential risk to life were excluded from the study.
Intervention groups
The first group is patients who receive 30 mg of pethidine intravenously.
The second group is patients who receive 60 mg of ketorolac intravenously.
Main outcome variables
the pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200728048244N1
Registration date:2020-08-17, 1399/05/27
Registration timing:registered_while_recruiting
Last update:2020-08-17, 1399/05/27
Update count:0
Registration date
2020-08-17, 1399/05/27
Registrant information
Name
Ameneh Ranjbar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4244 2348
Email address
samira.rb24@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-29, 1398/12/10
Expected recruitment end date
2020-08-31, 1399/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ketorolac and pethidine on analgesia and drug use after lower limb orthopedic surgery by spinal anesthesia
Public title
Comparison of ketorolac and pethidine in analgesia after orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lower limb fractures
Exclusion criteria:
History of drug addiction
History of migraine
Inability to communicate properly with the patient to evaluate postoperative pain
Need to be admitted to the ICU after surgery
Patients in ASA class 2
Age
From 15 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients participating in the present study were divided into two groups by tossing coins.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study participant, the researcher, and the data collector were unaware of which group the individuals belonged to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom University of Medical Sciences, Motahhari Blvd, Jahrom
City
Jahrom
Province
Fars
Postal code
7167758256
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.JUMS.REC.1397.149
Health conditions studied
1
Description of health condition studied
Pain in orthopedic patients
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
the pain
Timepoint
After surgery, first in recovery at zero hours, then at 6, 12, 18 and 24 hours after surgery
Method of measurement
pain assessment ruler
Secondary outcomes
1
Description
Vital signs
Timepoint
In minutes 5, 10, 20 and 60, 90 and 120
Method of measurement
monitoring
Intervention groups
1
Description
Intervention group1: They receive 30 mg of pethidine intravenously
Category
Treatment - Drugs
2
Description
Intervention group2:They receive 30 mg of ketorolac intravenously