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The effect of local ketamine injection at the site of tonsillectomy in reducing post-tonsillectomy pain in adult: Randomized clinical trial with concurrent control group

Protocol summary

Study aim
Investigating the effect of local injection of ketamine at the tonsillectomy site in reducing pain after tonsillectomy in adults during a randomized clinical trial with the same control group at Bo Ali Sina Hospital in Sari in 2024
Design
The clinical trial has a control group, with parallel groups, double-blind, randomized, phase 2-3 on 42 patients, for randomization using Random allocation software.
Settings and conduct
This study will be conducted in 2013 in a 6-month period on patients over 18 years of age who are candidates for tonsillectomy, hospitalized in Bo Ali Sina Hospital, Sari, in a double-blind manner. Patients will undergo a tonsillectomy by a surgeon.
Participants/Inclusion and exclusion criteria
Inclusion criteria include age over 18 years, indication of tonsillectomy surgery in adults according to the physician's opinion, ability to communicate verbally and written consent. History of drug addiction, use of painkillers, peripheral neuropathy, use of antipsychotic drugs, history of cardiovascular diseases, and history of arrhythmia will be considered as exclusion criteria.
Intervention groups
This study will be conducted on people over 18 years of age who undergo tonsillectomy surgery, by a surgeon and with a certain method. 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.
Main outcome variables
Primary outcome: pain secondary consequences 1- Nausea and vomiting 2- Agitation 3- Dysrhythmia 4- Hemodynamics 5- Bleeding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231216060427N2
Registration date: 2024-07-01, 1403/04/11
Registration timing: registered_while_recruiting

Last update: 2024-07-01, 1403/04/11
Update count: 0
Registration date
2024-07-01, 1403/04/11
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
2024-04-20, 1403/02/01
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of local ketamine injection at the site of tonsillectomy in reducing post-tonsillectomy pain in adult: Randomized clinical trial with concurrent control group
Public title
The effect of local ketamine injection at the site of tonsillectomy in reducing post-tonsillectomy pain in adult: Randomized clinical trial with concurrent control group
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age over 18 years recurrent or chronic tonsillitis (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 years) suspicion of tonsil malignancy upper airway obstruction secondary to tonsillar hypertrophy (obstructive sleep apnea) recurring abscesses around the tonsils the ability to communicate verbally provide written consent
Exclusion criteria:
A history of drug addiction taking painkillers more than 4 times a week peripheral neuropathy antipsychotic drugs history of cardiovascular diseases history of arrhythmia
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 42
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
2024-05-20, 1403/02/31
Ethics committee reference number
IR.MAZUMS.REC.1403.090

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
Primary outcome: pain The patient's pain in recovery, 6 hours after the operation and 24 hours after the operation will be measured with the VAS scale and by the technician or nurse present in the recovery and ward in a blind manner and without the knowledge and knowledge of the local injection of ketamine. VAS (visual analog scale) Visual analog scale (VAS) is a psychometric response scale that can be used in questionnaires. It is a measurement tool for mental characteristics or attitudes that cannot be measured directly. When answering a VAS item, respondents indicate their level of agreement with a statement by indicating a position along a continuous line between the two endpoints. It is common to use this scale to measure pain. In the numerical part, the person rates their pain using a scale of 0 to 10. 0 means no pain, 1-2 mild pain, 3-4 moderate pain that interferes with activity, 5-6 moderate pain that interferes with concentration, 7-8 severe pain that interferes with meeting basic needs and -10 9. The pain is very intense and unbearable.
Timepoint
In recovery, 6 hours after surgery and 24 hours after surgery
Method of measurement
It will be measured blindly by the technician or nurse present in the recovery and ward without the knowledge of the local injection of ketamine.

Secondary outcomes

1

Description
1-Nausea and vomiting: The patient's nausea in the recovery, 6 hours after the operation and 24 hours after the operation will be evaluated verbally and descriptively by the technician or nurse present in the recovery and the department blindly and without knowledge and knowledge of the local injection of ketamine. In this method, less than 2 bouts of nausea in the patient will be considered mild nausea, and if there are two or more bouts of nausea in the patient, moderate nausea will be considered, while the occurrence of vomiting will be equivalent to severe nausea.
Timepoint
In recovery, 6 hours after surgery and 24 hours after surgery
Method of measurement
It will be measured blindly by the technician or nurse present in the recovery and ward without the knowledge of the local injection of ketamine.

2

Description
2- Agitation Agitation in the recovery, 6 hours after the operation and 24 hours after the operation will be checked with the Ramsay sedation scale by the technician or nurse present in the recovery and ward blindly and without knowledge of the local injection of ketamine.
Timepoint
In recovery, 6 hours after surgery and 24 hours after surgery
Method of measurement
It will be measured blindly by the technician or nurse present in the recovery and ward without the knowledge of the local injection of ketamine.

3

Description
3- Dysrhythmia The occurrence of dysrhythmias in the patient will be investigated during recovery under cardiac monitoring blindly and without knowledge of local injection of ketamine.
Timepoint
In recovery
Method of measurement
It will be measured blindly by the technician or nurse present in the recovery without the knowledge of the local injection of ketamine.

4

Description
4- Hemodynamics The patient's hemodynamics, including heart rate, saturation, blood pressure, and respiratory rate during recovery, 6 hours after surgery, and 24 hours after surgery will be measured blindly by a technician or nurse present in the recovery room and department without the knowledge of local injection of ketamine. .
Timepoint
In recovery, 6 hours after surgery and 24 hours after surgery
Method of measurement
It will be measured blindly by the technician or nurse present in the recovery and ward without the knowledge of the local injection of ketamine.

5

Description
5- Bleeding The occurrence of bleeding after surgery in the recovery, 6 hours after the operation and 24 hours after the operation will be checked by the technician or the nurse present in the recovery and the department blindly and without the knowledge and knowledge of the local injection of ketamine.
Timepoint
In recovery, 6 hours after surgery and 24 hours after surgery
Method of measurement
It will be measured blindly by the technician or nurse present in the recovery and ward without the knowledge of the local injection of ketamine.

Intervention groups

1

Description
Intervention group: This study will be conducted on people over 18 years of age who undergo tonsillectomy surgery by a surgeon and with a certain method. 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. Anesthesia protocol: After not consuming food for 8 hours before surgery by all patients, induction of anesthesia in the same way with intravenous fentanyl at a dose of 2μg/kg (Aborihan Pharmaceutical Company/Made in Iran/ under the brand name Feniject), intravenous sodium thiopental at a dose of 5mg /kg (Kavash Gostardaro pharmaceutical company/made in Iran/ under the brand name Thiopental VUAB) and intravenous atracurium at a dose of 0.5mg/kg (Caspian pharmaceutical company/made in Iran/ Atracurium). Patients are intubated with a cuffed tube and gas is placed in the throat in order to prevent blood from entering the stomach due to its nauseous nature. Anesthesia was continued with oxygen (50%), nitrous oxide (50%) and isoflurane (1.2%).At the end of the surgery, after the effect of the muscle relaxants returned, the mouth and pharynx of the patients were washed with normal saline, and after the presence of spontaneous breathing with sufficient volume and airway reflexes, the tracheal tube was removed and they were transferred to the recovery room. Surgical protocol: In the patients of the intervention group, 5 minutes after anesthesia and intubation and before the surgical incision, the tonsil is pulled medially with a tonsil grabber to create a groove in the tonsil bed at the junction of the capsule with the tonsil bed. Then, the drug is injected at the rate of 1mg/kg in a submucosal form on the lateral side of the groove created in the two upper and lower bridges. At least 3 minutes are given to the patient for the effect of drug injection to start, before the occurrence of bleeding caused by tonsillectomy surgical incision and finally tonsillectomy is performed. The surgical protocol is the same for all patients and is performed by one doctor
Category
Treatment - Drugs

2

Description
Control group: The control group receives standard treatment and does not receive any medication. If pain relief is needed after surgery, intravenous acetaminophen is used at a dose of 12 mg/kg every 4 hours or 15 mg/kg every 6 hours with a maximum dose of 75 mg/kg within 24 hours.
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?
Yes
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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