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IRCT201506159014N70 IRCT 2015-06-18 Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Effect of inhalation aromatherapy with lavender and chamomile essential oils versus acetaminophen on post adenotonsillectomy pain in children Effect of inhalation aromatherapy with lavender and chamomile essential oils versus acetaminophen on post adenotonsillectomy pain in children: a triple blind randomized clinical trial 2015-07-01 anticipated 144 Complete https://irct.ir/trial/9509 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: The patients will be randomly assigned to intervention and control groups using block randomization of 12 group. Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind. 2 Tonsillitis. Intervention 1: Lavender essential oils 1%, 3 drops every 6 hours during the first 24 hours and then, every 8 hours for the next 48 hours through inhalation plus oral acetaminophen 10 to 15 mg/kg. Intervention 2: Chamomile essential oils 1%, 3 drops every 6 hours during the first 24 hours and then, every 8 hours for the next 48 hours through inhalation plus oral acetaminophen 10 to 15 mg/kg. Intervention 3: Lavender and chamomile compound essential oils 1%, 3 drops every 6 hours during the first 24 hours and then, every 8 hours for the next 48 hours through inhalation plus oral acetaminophen 10 to 15 mg/kg. Intervention 4: Distilled water 3 drops every 6 hours during the first 24 hours and then, every 8 hours for the next 48 hours through inhalation plus oral acetaminophen 10 to 15 mg/kg.
public Dr Mohammad Alipoor
Besat Hospital, Shahed Square
Hamadan Iran (Islamic Republic of) +98 81 3364 0030 dralipour76@yahoo.com Besat Hospital scientific Dr Mohammad Saeid Ahmadi
Besat Hospital, Shahed Square
Hamadan Iran (Islamic Republic of) +98 81 3364 0030 ahmadi@umsha.ac.ir Besat Hospital Iran (Islamic Republic of) Inclusion criteria: (a) age of 5 to 12 years; (b) candidate for adenotonsillectomy. Exclusion criteria: (a) history of allergy; (b) sensitivity to ethers and aromatic compounds; (c) history of asthma; (d) severe bleeding during operation; (e) using analgesic during operation. 5 years 12 years Both J35.0 Chronic tonsillitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Lavender essential oils 1%, 3 drops every 6 hours during the first 24 hours and then, every 8 hours for the next 48 hours through inhalation plus oral acetaminophen 10 to 15 mg/kg. Chamomile essential oils 1%, 3 drops every 6 hours during the first 24 hours and then, every 8 hours for the next 48 hours through inhalation plus oral acetaminophen 10 to 15 mg/kg Lavender and chamomile compound essential oils 1%, 3 drops every 6 hours during the first 24 hours and then, every 8 hours for the next 48 hours through inhalation plus oral acetaminophen 10 to 15 mg/kg Distilled water 3 drops every 6 hours during the first 24 hours and then, every 8 hours for the next 48 hours through inhalation plus oral acetaminophen 10 to 15 mg/kg Assessing the pain on the operational location. Timepoint: every 6 hours for 3 days. Method of measurement: using visual analog scale. Assessing nausea and vomiting. Timepoint: every 6 hours for 3 days. Method of measurement: through question from the patient. Assessing bleeding form the operational location. Timepoint: every 6 hours for 3 days. Method of measurement: through physical examination. Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences Approved 2015-05-23 Ethic Committee of Hamadan University of Medical Sciences Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Iran (Islamic Republic of)