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IRCT20221127056627N2 IRCT 2024-09-18 Shiraz University of Medical Sciences Comparison of the effect of lidocaine- paracetamol with lidocaine- ketamine on post-tonsillectomy pain relief in children Comparison of the effect of lidocaine- paracetamol with lidocaine- ketamine on post-tonsillectomy pain relief in children 2024-10-01 anticipated 114 Complete https://irct.ir/trial/78788 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated into three groups by block randomization. In this technique, a permutation block of size 6 will be made for patients of three groups A, B and C. In each block, equal numbers for three groups will be considered in alternative positions. Then 19 blocks of size 6 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: Drugs are provided in the form of similar 10 cc syringes by the first person, these drugs, which have the same color and size and in similar colors, are injected by the second person who is completely unaware of the contents of the syringes. 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(A): After selection of target group, ampoule of lidocaine with a dose of 1 mg/kg will be prepared as Similar syringes 10 cc plus Paracetamol 15 mg/kg .This solution will be injected intravenously to the patient 15 minutes before the start of surgery by angioket number (22-24). Intervention 2: Intervention group(B): After selection of target group, ampoule of Lidocaine with a dose of 1 mg/kg will be prepared as Similar syringes 10 cc plus 0.25 mg/kg of ketamine . This solution will be injected intravenously to the patient 15 minutes before the start of surgery by angioket number (22-24). Intervention 3: Control group: After selection of target group, ampoule of lidocaine with a dose of 1 mg/kg will be prepared as Similar syringes 10 cc plus normal saline (with the same volume of the studied drugs) is prepared as a placebo. This solution will be injected intravenously to the patient 15 minutes before the start of surgery by angioket number (22-24). No - There is not a plan to make this available Justification or reason for not sharing IPD is It is against our policy.
public Mahsa Jalilpoura gdam
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 0987136474270 mahsa.jalilpour@yahoo.com Shiraz University of Medical Sciences scientific Zeinabsadat Fattahi Saravi
Anesthesia Department- Operation Room- Nemazee Hospital- Zande Blvd
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4270 zefattahi@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with ASA grade I or II (American Society of Anesthesiology classification) Patients between 3 and 10 years old Patients undergoing open tonsillectomy 3 years 10 years Both Allergy to the drugs used in the study significant cognitive impairment in children Positive history of Heart, kidney diseases and chronic pain. Lack of parental consent J35.01 Chronic tonsillitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group(A): After selection of target group, ampoule of lidocaine with a dose of 1 mg/kg will be prepared as Similar syringes 10 cc plus Paracetamol 15 mg/kg .This solution will be injected intravenously to the patient 15 minutes before the start of surgery by angioket number (22-24). Intervention group(B): After selection of target group, ampoule of Lidocaine with a dose of 1 mg/kg will be prepared as Similar syringes 10 cc plus 0.25 mg/kg of ketamine . This solution will be injected intravenously to the patient 15 minutes before the start of surgery by angioket number (22-24). Control group: After selection of target group, ampoule of lidocaine with a dose of 1 mg/kg will be prepared as Similar syringes 10 cc plus normal saline (with the same volume of the studied drugs) is prepared as a placebo. This solution will be injected intravenously to the patient 15 minutes before the start of surgery by angioket number (22-24). Pain after surgery. Timepoint: 15, 30 and 45 minutes after surgery in recovery. Method of measurement: Wong-Baker Pain Scale. Shiraz University of Medical Sciences Approved 2024-03-05 Ethics Committee of Shiraz Medical School. 3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)