Protocol summary

Study aim
The effect of topical ketamine injection at the site of tonsillectomy in reducing post-tonsillectomy pain in people under 18 years of age in Booalisina hospital from 2023 to 2024
Design
Clinical trial, with parallel groups, randomized, double-blind, phase 2-3 on 60 patients, Random allocation software will be used for randomization.
Settings and conduct
The total sample in each group is 30 people, which will be performed on patients under 18 years of age who are candidates for tonsillectomy, hospitalized in Bo Ali Sina Hospital, Sari during the years 2023 to 2024. /kg of ketamine locally and the second group is considered as a control group that does not receive any medicine.In case of pain control with topical ketamine and the need for painkillers Intravenous acetaminophen is used at a dose of 12 mg/kg every 4 hours with a maximum dose of 75 mg within 24 hours. Post-operative pain (during recovery, 6 and 12 hours after the operation) using The eye analog criterion is asked to the patient by a trained nurse during recovery, hospitalization and under patient observation in the hospital.
Participants/Inclusion and exclusion criteria
A person's willingness to participate in obtaining informed consent. Chronic tonsillitis characterized by 7 or more episodes of sore throat per year for two consecutive years or 3 or more episodes of sore throat per year for three consecutive years.Occurrence of obstructive symptoms related to tonsil hypertrophy.Patients of both sexes under 18 years of age.
Intervention groups
The first group is the intervention group, which receives 1mg/kg of ketamine topically.The control group does not receive medication and the patient's pain is treated with intravenous acetaminophen at a dose of 12 mg/kg every 4 hours with a maximum dose of 75 mg within 24 hours after surgery
Main outcome variables
Postoperative pain measurement time; the amount of pain after the operation.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231216060427N1
Registration date: 2024-01-09, 1402/10/19
Registration timing: registered_while_recruiting

Last update: 2024-01-09, 1402/10/19
Update count: 0
Registration date
2024-01-09, 1402/10/19
Registrant information
Name
Mahsa Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4723 5778
Email address
drmahsaheidari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical ketamine injection at the site of tonsillectomy in reducing post-tonsillectomy pain in people under 18 years of age in Booalisina hospital from 2023 to 2024
Public title
The effect of topical ketamine injection at the site of tonsillectomy in reducing post-tonsillectomy pain in people under 18 years of age in Booalisina hospital from 2023 to 2024
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
A person's willingness to participate in obtaining informed consent Chronic tonsillitis characterized by 7 or more episodes of sore throat per year for two consecutive years or 3 or more episodes of sore throat per year for three consecutive years. Occurrence of obstructive symptoms related to tonsil hypertrophy Patients of both sexes under 18 years of age
Exclusion criteria:
The patient's unwillingness to continue to cooperate in the study History of taking painkillers Patients with a history of bleeding disorders Hemoglobin less than 10 g/dL History of rheumatological diseases Patients who have difficulty expressing pain
Age
From 5 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To control the intervening variables and also to balance the groups in terms of number, a random block method was used based on the order of patients' entry, that is, from the first four patients, the data of 4 patients were allocated to two groups using random allocate software. Then this allocation of four continued until the samples were completed based on the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
After selecting the samples, none of the sampled people will know about randomization and the process of allocation to groups. Patients are included in the study in the order of table numbers. In the intervention group, at the beginning of the surgery, ketamine at a dose of 1mg/kg will be injected locally in the tonsillectomy area for all patients by the attending physician in the operating room. And the control group does not receive medicine. In the case of blinding, the patient and the nurse responsible for evaluating the pain score do not know whether the medicine has been injected into the patient or not. The student is an observer in the operating room.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, at the begining of Valiasr Highway, Joibar three ways, imam Square,Sari, Mazndaran Province
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2023-12-13, 1402/09/22
Ethics committee reference number
IR.MAZUMS.REC.1402.512

Health conditions studied

1

Description of health condition studied
Tonsillitis
ICD-10 code
J35
ICD-10 code description
Chronic diseases of tonsils and adenoids

Primary outcomes

1

Description
The outcome of the patient's pain intensity after the operation based on the eye analog criterion
Timepoint
Pain intensity during recovery, 6 and 12 hours after surgery
Method of measurement
These results are measured by the evaluator, who is a trained nurse, who does not know about the allocation of the study subjects to each of the two allocation groups and the drugs used. Pain intensity is recorded during recovery 6 and 12 hours after the operation. The instrument for measuring this variable is based on the visual analog scale, and the face part of the visual analog scale will be used to measure the pain of patients aged 5 to 7 years, and the numerical part will be used to measure the pain of patients over 7 years old, and the help of the patient's parents will be taken to measure the pain.​

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, at the beginning of the surgery, ketamine at a dose of 1mg/kg will be injected locally in the tonsillectomy area for all patients by the attending physician in the operating room.
Category
Treatment - Drugs

2

Description
Control group: The control group does not receive medication and the patient's pain is treated with intravenous acetaminophen at a dose of 12 mg/kg every 4 hours or 15 mg/kg every 6 hours with a maximum dose of 75 mg within 24 hours after the operation.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sari Buali Sina Hospita
Full name of responsible person
Mahsa Heidari
Street address
Buali Sina Hospital, First of Ghaemshahr road. Sari
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۸۳۸۴۷۷
Phone
+98 11 3304 4001
Email
Publicrel@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Pedram Ebrahimnejad
Street address
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
City
Sari
Province
Mazandaran
Postal code
4414733971
Phone
+98 11 3303 4001
Email
Publicrel@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mahsa Heidari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4001
Email
drMahsaheidari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahsa Heidari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4001
Email
drMahsaheidari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahsa Heidari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4001
Email
drMahsaheidari@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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