The comparison of single-dose preoperative intravenous ketorolac and paracetamol on postoperative pain after septorhinoplasty
Design
Three-group clinical trial (2 intervention groups and 1 control group), with parallel groups, double-blind, randomized, phase 3 on 108 patients aged 18 to 50 years of class I and II ASA who are candidates for septorhinoplasty. The random sequence generation site (www.sealedenvelope.com) is used for randomization.
Settings and conduct
108 patients in Ghadir Hospital in Shiraz are studied in 3 groups (36 patients in each group) and postoperative pain is evaluated. In group 1: 40 mg intravenous ketorolac in 100cc of normal saline is injected 30 minutes before surgery. 2: 1000 mg of paracetamol in 100cc of normal saline is injected 30 minutes before the operation. Group 3 (control) 100 cc of normal intravenous saline is injected 30 minutes before the operation. In this study, the anesthesiologist (who prepares the drugs and delivers the drug to the operating room), as well as the patient, anesthesia resident, and recovery nurse Data analyzers, are blinded to the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Obtaining informed consent Candidate patients for rhinoplasty with the age group of 18-50 years and class (ASA) I, II. Exclusion criteria: History of drug allergy to ketorolac and paracetamol History of long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) and narcotics
Intervention groups
In the intervention group,1: (n = 36) 40 mg of ketorolac is injected intravenously in 100cc of normal saline 30 minutes before the operation. In group 2: (n = 36), 1000 mg Paracetamol is injected in 100cc of normal saline 30 minutes before the operation, and in the control group (36 people) 100cc of normal saline is injected 30 minutes before the operation.
Main outcome variables
Postoperative pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180922041084N6
Registration date:2022-03-08, 1400/12/17
Registration timing:prospective
Last update:2022-03-08, 1400/12/17
Update count:0
Registration date
2022-03-08, 1400/12/17
Registrant information
Name
Maryam Tabibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1460
Email address
dpt2370349433@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-05-31, 1401/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of single dose preemptive intravenous ketorolac and paracetamol on postoperative pain after septorhinoplasty
Public title
The comparison of single dose preemptive intravenous ketorolac and paracetamol on postoperative pain after septorhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining informed consent
Candidate patients for rhinoplasty with age group of 18-50 years and class (ASA) I, II
Exclusion criteria:
History of drug allergy to ketorolac and paracetamol
History of long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) and narcotics
History of gastrointestinal bleeding,
Stomach ulcers or inflammatory bowel disease
Diabetes or neuropathic diseases
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, using the random blocking method, 108 patients are divided into 12 blocks with a size of 9 into three groups. Blocking will be determined using a random number table of random number generation software. Blocking and sequencing for concealment by a non-involved person in the study will be done by matched opaque envelopes. Paracetamol and a control group of normal saline will be given. Then, based on the obtained blocks and in the order of allocation, the drugs will be given to the patients. This study is a two-way blind.
Blinding (investigator's opinion)
Double blinded
Blinding description
The medicines are prepared by an anesthesiologist who is not aware of how the study is performed and are delivered to the anesthesiologist in the operating room, who is also unaware of how the study is performed. Transferring the patient to the recovery room and handing over the patient to the recovery staff will not give them any information and thus the patient, anesthesia resident and recovery nurse, and the inpatient ward and data analyzer will be blinded to the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciencs
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2021-11-15, 1400/08/24
Ethics committee reference number
IR.SUMS.MED.REC.1400.603
Health conditions studied
1
Description of health condition studied
rhinoplasty surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post operative pain
Timepoint
At 1, 6, 12 and 24 hours after surgery
Method of measurement
VAS SCORE scoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: To the group receiving ketorolac (36 people) 40 mg of ketorolac (made by Raha company) is injected intravenously in 100cc of normal saline 30 minutes before the operation.
Category
Treatment - Surgery
2
Description
Intervention group: In the group receiving paracetamol (36 people) 1000 mg of paracetamolMade by Samen Company of Mashhad) in 100cc of normal saline is injected 30 minutes before the operation.
Category
Treatment - Surgery
3
Description
Control group: The control group (36 people) is injected with 100 cc of normal intravenous saline 30 minutes before the operation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Mother and Child Hospital
Full name of responsible person
ZAHRA MESKOOB SARAVI
Street address
Above the Quran Gate - Golshan Town - Ghadir Mother and Child Specialized and Sub-Specialized Hospital
City
Shiraz
Province
Fars
Postal code
7194786489
Phone
+98 71 3227 9701
Email
GHADIRHOSPITAL@YAHOO.COM
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab memarpoor
Street address
Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3234 9333
Email
Vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Shirin Farrokhyani
Position
Anesthesiology resident/physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3630 4312
Email
poopanak@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Laleh Dehghan Pisheh
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4270
Email
lalehdehghan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
MaryamTabibzadeh
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
drtabib.maryam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is against our policy
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available