Comparison of intraoperative administration of ketorolac with morphine in pain control and postoperative nausea and vomiting in patients undergoing rhinoplasty in Jahrom in 2022
Comparison of intraoperative administration of ketorolac with morphine in pain control and postoperative nausea and vomiting in patients undergoing rhinoplasty
Design
This study will be a double-blind randomized clinical trial with parallel groups on 114 patients referred to Motahhari Hospital in Jahrom who are undergoing rhinoplasty surgery.
Settings and conduct
Patients referred to Motahhari Hospital in Jahrom who will undergo rhinoplasty surgery will be included in the study. Patients participating in the study will be divided into two groups of morphine and ketorolac by throwing coins. The person participating in the study, the researcher and the data collector will be unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients referred to Motahhari Hospital in Jahrom who underwent rhinoplasty and expressed their consent to participate in the study. Exclusion criteria: no hemodynamic stability; suffering from acute and chronic pain.
Intervention groups
Intervention group 1: 0.5 mg / kg morphine will be injected intravenously after induction of anesthesia. Intervention group 2: 30 mg ketorolac (ampoule) will be injected intravenously after induction of anesthesia. It should be noted that the anesthesia method will be the same in both groups.
Main outcome variables
Pain; nausea; vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210415050976N8
Registration date:2021-10-20, 1400/07/28
Registration timing:prospective
Last update:2021-10-20, 1400/07/28
Update count:0
Registration date
2021-10-20, 1400/07/28
Registrant information
Name
navid kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 6085
Email address
k.navid@juma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-01, 1400/08/10
Expected recruitment end date
2022-08-01, 1401/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intraoperative administration of ketorolac with morphine in pain control and postoperative nausea and vomiting in patients undergoing rhinoplasty in Jahrom in 2022
Public title
Comparison of intraoperative administration of ketorolac with morphine in pain control and postoperative nausea and vomiting in patients undergoing rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Rhinoplasty under general anesthesia
No history of allergy to morphine and ketorolac
Exclusion criteria:
Drug addiction
Underlying cardiovascular disease
Patients with coagulation disorders or platelets less than one hundred thousand
Patients with a history of renal insufficiency and serum creatinine more than one and a half
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in the present study, the double-blind method is used so that 1- the person reviewing the results and 2- the person performing the injections do not know which patient received morphine or ketorolac.
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, Shahid Motahari Boulevard, Jahrom University of Medical Sciences, Vice Chancellor for Research
City
Jahrom
Province
Fars
Postal code
7167758256
Approval date
2021-09-29, 1400/07/07
Ethics committee reference number
IR.JUMS.REC.1400.043
Health conditions studied
1
Description of health condition studied
Rhinoplasty surgery
ICD-10 code
Y81
ICD-10 code description
General- and plastic-surgery devices associated with adverse incidents
Primary outcomes
1
Description
the pain
Timepoint
Periods immediately after surgery, 15 minutes, 3 hours and 6 hours after surgery
Method of measurement
VAS criteria
2
Description
nausea and vomiting
Timepoint
After surgery
Method of measurement
Nausea and vomiting questionnaire
Secondary outcomes
1
Description
Vital signs
Timepoint
Immediately after surgery and then at 15, 3 and 6 minutes after surgery
Method of measurement
monitoring
Intervention groups
1
Description
Intervention group 1: 0.5 mg / kg morphine will be injected intravenously after induction of anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group 2: 30 mg ketorolac (ampoule) will be injected intravenously after induction of anesthesia. It should be noted that the anesthesia method will be the same in both groups.