(1) Objective: Determining the effect of Ketorolac and Paracetamol on pain control after inguinal hernia surgery.
(2) Design: Double blind clinical trial study
(3) Setting and conduct: Selecting 74 patients under elective inguinal hernia surgery at 5Azar tertiary hospital affiliated to Golestan university of medical sciences and assigning them to two intervention groups by simple random allocation.
(4) Participants including major eligibility criteria: Inclusion Criteria: age between 20 to 50 years; American Society of Anesthesiologists (ASA) physical status classification system I and II; without chronic and psychologic diseases; no addiction to substance; Under general anesthesia and inducing anesthesia by Fentanyl (1 mcg/ kg), Sodium Thiopental (5 mg/ kg), and Atracurium (0.5 mg/ kg) and maintain it by nitrous oxide (N2O) and Izoflurane; and filling the informed consent form. Exclusion Criteria: needing to administration of extra dosage of drug, another drug; or alternative therapy.
(5)Intervention: Injection of Paracetamol (15 mg/ kg every 6 hours, maximal dosage of 60 mg/ kg, daily) for the first group, and injection of Ketorolac (maximal dosage of 120 mg, daily) for the second intervention group after one hour after Fentanyl injection.
(6) Main outcome measures (variable): Pain after inguinal hernia surgery for two intervention groups for 6 hours after Ketorolac and Paracetamol injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041033350N1
Registration date:2017-05-04, 1396/02/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-05-04, 1396/02/14
Registrant information
Name
Ali Mahmoud Janlou
Name of organization / entity
Golestan university of Medical Sciences, Gorgan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 17 3235 4936
Email address
mahmoud.janlou@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Golestan University of Medical Sciences, Gorgan, Iran
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2017-07-06, 1396/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ketorolac and Paracetamol on Pain Control after Inguinal Hernia Surgery
Public title
Effect of Ketorolac and Paracetamol on Pain Control after Hernia Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: age between 20 to 50 years; American Society of Anesthesiologists (ASA) physical status classification system I and II; without chronic and psychologic diseases; no addiction to substance; Under general anesthesia and inducing anesthesia by Fentanyl (1 mcg/ kg), Sodium Thiopental (5 mg/ kg), and Atracurium (0.5 mg/ kg) and maintain it by nitrous oxide (N2O) and Izoflurane; and filling the informed consent form. Exclusion Criteria: needing to administration of extra dosage of drug, another drug; or alternative therapy.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Postal code: 4934174515, beginning of the Shastkola road, Falsafi educational campus, Gorgan, Golestan province, Iran.
City
Gorgan
Postal code
4934174515
Approval date
2017-02-12, 1395/11/24
Ethics committee reference number
IR.GOUMS.REC.1395.241
Health conditions studied
1
Description of health condition studied
inguinal hernia surgery
ICD-10 code
k40
ICD-10 code description
inguinal hernia
Primary outcomes
1
Description
Pain after inguinal hernia surgery
Timepoint
6 hours after injection of Paracetamol and Ketorolac during time period of 1 hour, every half an hour for 2 hours, and every one hour for 3 hours.
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Injection of Paracetamol (15 mg/ kg every 6 hours, maximal dosage of 60 mg/ kg, daily) one hour after Fentanyl injection.
Category
Treatment - Drugs
2
Description
Second intervention group: injection of Ketorolac (maximal dosage of 120 mg, daily) one hour after Fentanyl injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
5 Azar tertiary hospital affiliated to Golestan University of Medical Sciences