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IRCT20100127003213N10 IRCT 2023-05-14 Shiraz University of Medical Sciences Evaluation of effects of Gabapentin, Dexamethasone and Ropivacaine on tonsillectomy pain in adults. Evaluation of effects of Gabapentin, Dexamethasone and Ropivacaine on pain after tonsillectomy surgery in adult patients. 2023-06-01 anticipated 50 Complete https://irct.ir/trial/69978 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated into two groups by block randomization. In this technique, a permutation block of size 10 will be made for patients of two groups A & B. In each block, equal numbers for two groups will be considered in alternative positions. Then 5 blocks of size 10 will be selected randomly and patients will be allocated randomly and equally into three groups according to these permutation block. block sequence will be prepare by www.sealedenvelope.com, Blinding description: In the intervention group, patients will use 300 mg of Gabapentin orally three days before the operation, while patients in the control group will receive capsules similar to Gabapentin (in terms of appearance) and as a placebo. In the operating room, all study drugs will be provided by the only person familiar with the study (Nurse anesthetist). The anesthesiologist, patients, and other personnel involved in the work are blinded to the drugs injected in this study. This study is double-blind. 2-3 Tonsillectomy. Intervention 1: Intervention group: Patients will use 300 mg of Gabapentin orally three times a day three days before the operation, and this regimen will continue until ten days after the operation. The anesthesia induction method will be similar in the two study groups. After anesthesia, patients in the intervention group will receive 8 mg of Dexamethasone intravenously. At the end of the surgery, the surgeon will inject 4 ml of half percent Ropivacaine solution in the tonsil cavity and its surrounding areas on each side. In both study groups, postoperative patients will receive a basic analgesic regimen including Acetaminophen 325 mg four times a day and Celecoxib 200 mg twice a day for one week. In addition, 5 mg Oxycodone tablets will be provided to them so that they can take one when the pain worsens. Intervention 2: Control group: Patients in the control group will receive capsules similar to Gabapentin (in appearance) with the same drug regimen as placebo three days before surgery. After anesthesia, the patients of the control group will receive 2 ml of distilled water in the same syringe and intravenously, and at the end of the surgery, the injections will be performed by the surgeon with the same syringe and the same volume of normal saline. In both study groups, postoperative patients will receive a basic analgesic regimen including Acetaminophen 325 mg four times a day and Celecoxib 200 mg twice a day for one week. In addition, 5 mg Oxycodone tablets will be provided to them so that they can take one when the pain worsens. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is against our policy.
public Ali Mohebpour
Anesthesiology Department, Faghihi Hospital, Zand Street.
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 ali_mohebpour@yahoo.com Shiraz University of Medical Sciences scientific Arash Farbood
Anesthesiology Department, Faghihi Hospital, Zand Street.
Shiraz Iran (Islamic Republic of) 1564471948 +98 36474270 arashfarbood@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Adult patients with ASA grade I or II (American Society of Anesthesiology classification) patients between 18 and 40 years old Body mass index (BMI) between 18 and 25 Candidate for tonsillectomy or adenotonsillectomy with diagnosis of tonsillitis The distance between the hospital and the patient's place of residence should be a maximum of 30 minutes by car 18 years 40 years Both Allergy to the drugs used in the study Positive history of liver, kidney, Coagulation disorders, Diseases of the digestive system, depression and anxiety Positive history of uncontrolled diseases of the cardiovascular system Addiction to drugs Obstructive sleep apnoea Taking painkillers other than study drugs in 24 hours before surgery J03.9 Acute tonsillitis, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Patients will use 300 mg of Gabapentin orally three times a day three days before the operation, and this regimen will continue until ten days after the operation. The anesthesia induction method will be similar in the two study groups. After anesthesia, patients in the intervention group will receive 8 mg of Dexamethasone intravenously. At the end of the surgery, the surgeon will inject 4 ml of half percent Ropivacaine solution in the tonsil cavity and its surrounding areas on each side. In both study groups, postoperative patients will receive a basic analgesic regimen including Acetaminophen 325 mg four times a day and Celecoxib 200 mg twice a day for one week. In addition, 5 mg Oxycodone tablets will be provided to them so that they can take one when the pain worsens. Control group: Patients in the control group will receive capsules similar to Gabapentin (in appearance) with the same drug regimen as placebo three days before surgery. After anesthesia, the patients of the control group will receive 2 ml of distilled water in the same syringe and intravenously, and at the end of the surgery, the injections will be performed by the surgeon with the same syringe and the same volume of normal saline. In both study groups, postoperative patients will receive a basic analgesic regimen including Acetaminophen 325 mg four times a day and Celecoxib 200 mg twice a day for one week. In addition, 5 mg Oxycodone tablets will be provided to them so that they can take one when the pain worsens. Pain. Timepoint: Every 15 minutes in the recovery room and three times a day (morning, noon and night) for ten days. Method of measurement: Visual Analog Scale for Pain. The quality of the patient's sleep. Timepoint: Every day for ten days. Method of measurement: In respect to standardized questionnaire. The first time to start normal food. Timepoint: Every day for ten days. Method of measurement: Patient history taking. Patient satisfaction rate. Timepoint: Every day for ten days. Method of measurement: In respect to standardized questionnaire. Shiraz University of Medical Sciences Approved 2023-03-05 Ethics Committee of Shiraz Medical School 3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)