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IRCT2013071814047N1 IRCT 2013-11-07 Vice chancellor for research, Tehran University of Medical Sciences Comparison of the effect of Acetaminophen and Ibuprofen in pain relief following Adenotonsillectomy. Comparison of the effect of Acetaminophen and Ibuprofen in pain relief and complication management following Adenotonsillectomy in 4-10 year old children. 2013-06-22 anticipated 50 Complete https://irct.ir/trial/13747 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study has been called triple blind. Treatment allocation is revealed neither to patients nor to the researcher who fills out the questionnaires. In addition the individuals who access the data do not know which treatment is assigned to each patient. 3 Adenotonsillectomy. Intervention 1: Intervention group 1: Syrup Ibuprofen 10mg/ kg orally, once an hour before surgery and then every 6 hour for 3 days was used. This syrup manufacturing company is Hakim co. in Iran and its concentration is 100 mg per 5 ml. Intervention 2: Intervention group 2: Syrup Acetaminophen 15mg/ kg orally, once an hour before surgery and then every 6 hours for 3 days was used. This syrup manufacturing company is Kimidaru co. in Iran and its concentration is 120 mg per 5 ml.
public Fatemeh Mirashrafi
Imam Khomeini Hospital, Dr. Mohammad Gharib Ave., Keshavarz Blvd., Enghelab St.
Tehran Iran (Islamic Republic of) +98 21 6658 1628 f-mirashrafi@sina.tums.ac.ir ENT research center, Imam Khomeini Hospital scientific Fatemeh Mirashrafi
Imam Khomeini Hospital, Dr. Mohammad Gharib Ave., Keshavarz Blvd., Enghelab St.
Tehran Iran (Islamic Republic of) +98 21 6658 1628 f-mirashrafi@sina.tums.ac.ir ENT research center, Imam Khomeini Hospital Iran (Islamic Republic of) Inclusion criteria: 1- No Allergy to Non Steroid Anti-Inflammatory Drugs 2- No History of coagulopathy 3- No Renal and Hepatic disorder 4- No Severe Asthma (recently admission or treatment with oral corticosteroid) 5- No Family history of coagulopathy 6- No Evidence of Mental retardation Exclusion Criteria: 1- Severe and uncontrollable bleeding during and after surgery 2- Severe pain after surgery which needs additional analgesic 4 years 10 years Both J35.1,J35. Enlargement of tonsils, Enlargement of adenoids Treatment - Drugs Treatment - Drugs Intervention group 1: Syrup Ibuprofen 10mg/ kg orally, once an hour before surgery and then every 6 hour for 3 days was used. This syrup manufacturing company is Hakim co. in Iran and its concentration is 100 mg per 5 ml. Intervention group 2: Syrup Acetaminophen 15mg/ kg orally, once an hour before surgery and then every 6 hours for 3 days was used. This syrup manufacturing company is Kimidaru co. in Iran and its concentration is 120 mg per 5 ml. Pain score. Timepoint: Six hours postoperative, at the end of first postoperative day, at the end of second postoperative day. Method of measurement: with visual analogue pain scale (1-10 score). Intraoperative bleeding volume. Timepoint: During the surgery. Method of measurement: Amount of bleeding in CC, according to the number of sterile gases that is used during the surgery and amount of blood at suction bottle. Bleeding at the first postoperative day. Timepoint: At the end of the first postoperative day. Method of measurement: questionnaire. Bleeding during the first postoperative week. Timepoint: At the end of first postoperative week. Method of measurement: questionnaire. Nausea. Timepoint: At the end of first postoperative day and at the end of first postoperative week. Method of measurement: questionnaire. Vomiting. Timepoint: At the end of first postoperative day and at the end of first postoperative week. Method of measurement: questionnaire. Time to start eating of oral liquids. Timepoint: At the end of first postoperative week. Method of measurement: questionnaire. Time to start eating of semisolid foods. Timepoint: At the end of first postoperative week. Method of measurement: questionnaire. Time to start eating of solid foods. Timepoint: At the end of first postoperative week. Method of measurement: questionnaire. Time to going back to their normal life. Timepoint: At the end of first postoperative week. Method of measurement: questionnaire. Overall satisfaction of recovery. Timepoint: At the end of first postoperative week. Method of measurement: Questionnaire. Vice chancellor for research, Tehran University of Medical Sciences Approved 2012-07-11 Ethics committee of Tehran University of Medical Sciences Sixth floor, central organization of University, next to Ghods Ave, Keshavarz Blvd. Tehran Iran (Islamic Republic of)