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IRCT20230926059532N1 IRCT 2023-10-14 Mazandaran University of Medical Sciences Comparison the effect of oral oxycodone Vs oral meloxicam on pre-emptive control of postoperative pain after tonsillectomy in adults Comparison the effect of oral oxycodone Vs oral meloxicam on pre-emptive control of postoperative pain after tonsillectomy in adults 2023-10-20 anticipated 70 Complete https://irct.ir/trial/72912 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. 2-3 Tonsil hypertrophy. Intervention 1: Intervention group: Oxycodone rapid release tablet 5 mg (Faran Shimi, Iran) orally 60 minutes before surgery. Intervention 2: Intervention group: They will receive 15 mg meloxicam tablets (Razak, Iran) orally 60 minutes before surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Dr. Maryam Montazemi
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3304 4001 Mmontazemi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Maryam Montazemi
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3304 4001 Mmontazemi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 J35.1 Hypertrophy of tonsils Prevention Prevention Intervention group: Oxycodone rapid release tablet 5 mg (Faran Shimi, Iran) orally 60 minutes before surgery. Intervention group: They will receive 15 mg meloxicam tablets (Razak, Iran) orally 60 minutes before surgery. 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 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. Mazandaran University of Medical Sciences Approved 2022-11-30 Ethic committee of mazandaran of medical sciences Mazandaran University of medical sciences, at the begining of Valiasr Highway, Joibar three ways, imam Square,Sari, Mazndaran Province Sari Mazandaran Iran (Islamic Republic of)