Protocol summary

Study aim
Comparison of the effect of oral oxycodone with oral meloxicam on preventive pain control after tonsillectomy surgery in adults.
Design
Clinical trial with parallel groups, triple blind, randomized, phase 2-3 on 70 patients. Random Elocit software will be used for randomization
Settings and conduct
This study is a randomized, controlled, triple-blind clinical trial, which aims to compare the effect of preventive prescription of two drugs, oxycodone and oral meloxicam, on pain control after tonsillectomy surgery in adults referred to Bou Ali Sina Sari Medical Training Center. 70 candidates for tonsillectomy, including adults with anesthesia class 1 and 2 (ASA), are selected as available. Sampling of all patients over 18 years of age who referred to Bo Ali Sina Hospital in Sari during the fall and winter of 1402, who are candidates for planned tonsillectomy with the indication of hypertrophy of the tonsils, abnormal tonsil size, recurrent tonsillitis or previous tonsillitis.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: candidate for planned tonsillectomy with tonsil hypertrophy indication, abnormal tonsil size, recurrent tonsillitis or previous tonsillitis, history of drug abuse before surgery. And exclusion criteria: history of any allergy to opioids, codeine, acetaminophen, aspirin, NSAID. Any contraindications for the use of NSAIDs (such as stomach ulcers, asthma, angioedema, nasal polyps);
Intervention groups
Patients in group O will receive quick-release oxycodone tablets 5 mg (Faran Shimi, Iran) and in group M, meloxicam tablets 15 mg (Razak, Iran) orally 60 minutes before the start of surgery.
Main outcome variables
The intensity of pain after surgery, the amount of painkillers used, the incidence of pain after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230926059532N1
Registration date: 2023-10-14, 1402/07/22
Registration timing: prospective

Last update: 2023-10-14, 1402/07/22
Update count: 0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
Maryam Montazami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3331 0905
Email address
mmontazemi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-20, 1402/07/28
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of oral oxycodone Vs oral meloxicam on pre-emptive control of postoperative pain after tonsillectomy in adults
Public title
Comparison the effect of oral oxycodone Vs oral meloxicam on pre-emptive control of postoperative pain after tonsillectomy in adults
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient willingness to participate in the study and gain informed consent candidate for planned tonsillectomy with the indication of hypertrophy of tonsils, abnormal tonsil size, recurrent tonsillitis or previous tonsillitis Age over 18 years BMI between 18 and 35
Exclusion criteria:
Patient dissatisfaction Age below 18 years History of bleeding diseases Renal failure Liver failure Chronic heart failure History of drug abuse before surgery History of long-term use of analgesics and NSAIDs regardless of the reason for its use History of any allergy to opioids, codeine, acetaminophen, aspirin, NSAID Any contraindications to the use of NSAIDs (such as peptic ulcer, asthma, angioedema, nasal polyps) History of obstructive sleep apnea Mental instability Pregnancy History of nasal polyps
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: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who met the criteria for entering the study were divided into two intervention and control groups using the block randomization method. Random Elokit software will be used to do this. And patients are selected in groups of 4 based on the time they entered the study and assigned to two study groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Before the operation, adequate explanations and training will be provided to the patients on how to determine the intensity of the pain after the operation using the NRS (Numeric Rating Scale) standard. Patients in group O will receive quick-release oxycodone tablets 5 mg (Faran Shimi, Iran) and in group M, meloxicam tablets 15 mg (Razak, Iran) orally 60 minutes before the start of surgery. The drug under study has been prepared in a numbered paper package and is given to all patients 60 minutes before the start of anesthesia by the associate nurse of the project, who does not know about the study groups, to be swallowed with a little water. All the prepared packages have two pills, one of which is one of the pills under study and the other pill is a placebo, and in terms of appearance, it completely matches with the other pill under study. The packages were prepared and numbered by the project pharmacologist colleague and The discretion of the prescribing nurse is placed. In our study, both the patient and the prescribing nurse were blinded to the prescribed medication. The surgeon and the pain evaluator based on the NRS criterion also do not know the type of drug used by the patient.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of mazandaran 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
۴۸۱۵۷۳۳۹۷۱
Approval date
2022-11-30, 1401/09/09
Ethics committee reference number
IR.MAZUMS.REC.1401.400

Health conditions studied

1

Description of health condition studied
Tonsil hypertrophy
ICD-10 code
J35.1
ICD-10 code description
Hypertrophy of tonsils

Primary outcomes

1

Description
The primary outcome of the comparison study of pain after surgery (yes/no)
Timepoint
After surgery
Method of measurement
These outcomes are measured by an experienced nurse who does not know the assignment of the studied subjects to each of the two allocation groups. Pain level of patients based on NRS (Numeric Rating Scale)

Secondary outcomes

1

Description
Secondary measurement of patients' pain intensity is based on NRS and the amount of use of painkillers.
Timepoint
The pain level of patients based on NRS in minutes (0, 30, 60, minutes after reaching recovery and then 6, 12 and 24 hours after discharge from recovery) will be asked and recorded.
Method of measurement
These outcomes are measured by an experienced nurse who does not know the allocation of the studied subjects to each of the two allocation groups. If the pain intensity is higher than 4 based on the NRS criteria, the patient is given intravenous acetaminophen one gram with a maximum limit of 4. grams per day and at least 6 hours between two doses, and the number of doses received will be recorded.

Intervention groups

1

Description
Intervention group: Oxycodone rapid release tablet 5 mg (Faran Shimi, Iran) orally 60 minutes before surgery.
Category
Prevention

2

Description
Intervention group: They will receive 15 mg meloxicam tablets (Razak, Iran) orally 60 minutes before surgery.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Sari Buali Sina Hospital
Full name of responsible person
Maryam Motazemi
Street address
Buali Sina Hospital, First of Ghaemshahr road. Sari
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱۴۸۱۵۷
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 3304 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
Dr. Maryam Montazemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
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
Mmontazemi@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Montazemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
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
Mmontazemi@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Montazemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
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
Mmontazemi@mazums.ac.ir

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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