Comparison of prophylactic use ketorolac with pethidine for prevention of shivering and pain after cesarean section under spinal anesthesia
Design
A clinical trial with parallel, double-blind, randomized by randomizer website, phase 3 was performed on 90 patients in the three equal groups.
Settings and conduct
Phase 3 clinical trial with three parallel groups was performed on 90 patients referred to Shahid Motahari Hospital in Urmia. Patients were enrolled in three equal groups (ketorolac = 30 people, pethidine=30 people and normal saline = 30people). In this study, patients and clinical assessor as well as statistical analyzers were unaware of group assignment. Randomization was done by randomizer website.
Participants/Inclusion and exclusion criteria
Inclusion criteria were age between 18 to 40 years old, American Society of Anesthesiologists (ASA) I and II and candidate for cesarean. Exclusion criteria were dissatisfaction to participate in the study and sensitivity to Non-steroidal anti-inflammatory drugs (NSAIDs)
Intervention groups
Intervention group 1: Intravenous ketorolac
Intervention group 2: Intravenous pethidine
Control group: normal saline
Main outcome variables
Shivering and pain after cesarean section
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201207049639N2
Registration date:2020-12-30, 1399/10/10
Registration timing:retrospective
Last update:2020-12-30, 1399/10/10
Update count:0
Registration date
2020-12-30, 1399/10/10
Registrant information
Name
Hadi Houshyar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
hooshyar.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-23, 1398/09/02
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
2020-04-27, 1399/02/08
Actual recruitment end date
2020-11-05, 1399/08/15
Trial completion date
2020-11-05, 1399/08/15
Scientific title
Comparison of prophylactic use ketorolac with pethidine for prevention of shivering and pain after cesarean section under spinal anesthesia
Public title
Effect of prophylactic use ketorolac with pethidine for prevention of shivering and pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 40 years old
American Society of Anesthesiologists (ASA) I and II
Candidate for cesarean
Exclusion criteria:
Dissatisfaction to participate in the study
Sensitivity to Non-steroidal anti-inflammatory drugs (NSAIDs)
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Women candidates for cesarean section were randomly divided into three groups receiving pethidine, ketorolac and normal saline using https://www.randomizer.at/.
Blinding (investigator's opinion)
Double blinded
Blinding description
Women were unaware of being in intervention groups. After spinal anesthesia, the drug is injected intravenously in a normal syringe because both drugs are colorless, so the patient is not able to identify the type of drug, so she is blind, and the statistical analyzer also Received the data as code A and B for the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Street, Jahad Ave., Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-11-20, 1398/08/29
Ethics committee reference number
IR.UMSU.REC.1398.321
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
At recovery, one hour after surgery, 24 hours after surgery
Method of measurement
Visual analogue Scale (VAS)
2
Description
Shivering
Timepoint
At recovery
Method of measurement
observation (Having / not having shivering)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In the first intervention group, patients received 30 mg of intravenous Ketorolac (Produced by Caspian) 10 minutes before spinal anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group 2: In the second intervention group, patients received 50 mg of intravenous pethidine (Produced by Caspian)10 minutes before spinal anesthesia.
Category
Treatment - Drugs
3
Description
Control group: In the control group, patients received 5 cc of normal intravenous saline 10 minutes before spinal anesthesia.