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IRCT20211007052693N1 IRCT 2021-11-20 Arak University of Medical Sciences Comparison of oral premedication of midazolam, ketamine and dexmedetomidine in sedation and facilitation of separation of children from parents for induction of anesthesia Comparison of oral premedication of midazolam, ketamine and dexmedetomidine in sedation and facilitation of separation of children from parents for induction of anesthesia 2021-12-11 anticipated 153 Complete https://irct.ir/trial/59366 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this double-blind randomized clinical trial study, 153 patients 2 to 10 years old, candidates for elective surgery, enter the study after obtaining the informed consent of the patient's parents or guardian. None of the children should receive sedatives before entering the operating room and they are randomly divided into 3 groups by block method, Blinding description: Unaware of the type of drug being prescribed, the intern pours the drug under the child's tongue by the syringe containing the intervention drug to be swallowed with a short pause in the mouth. The exact method is that in each group, after calculating the amount of drug based on the child's weight, to standardize and create an acceptable taste, one milliliter of 20% dextrose solution is added to the calculated intervention drug for each patient. Finally, to match the groups, the volume of the prescribed material with distilled water is increased to 5 ml. This double-blind study will be performed in such a way that patients with informed consent to enter the plan will not be aware of the type of drug used. Also, the intern, who is responsible for completing the questionnaires and recording the data, is not aware of the patients in the study groups and will not be aware of the type of oral solution. And will only complete the questionnaires based on the numbers to be assigned to the operating room by the anesthesiologist in charge of the project. 3 Condition 1: anesthesia. Condition 2: sedation. Intervention 1: Intervention group: The first group: midazolam half mg / kg (midazolam ampoule made by Caspian Tamin Company Rasht - Iran) after calculating the amount of drug based on the weight of the child, to equalize and create an acceptable taste of one ml of 20% dextrose solution to the intervention drug is calculated Is added for each patient, and finally, to match the groups, the volume of the prescribed substance with distilled water is increased to 5 ml, and by the intern, who is unaware of the type of drug prescribed, it is poured into the syringes containing the intervention drug under the child's tongue. To be swallowed with a little pause in the mouth. Intervention 2: Intervention group: The second group: Ketamine 5 mg/kg (ketamine consumed by Rotex Medica - Germany) after calculating the amount of drug based on the weight of the child, to equalize and create an acceptable taste of one ml of 20% dextrose solution to the intervention drug is calculated Is added for each patient, and finally, to match the groups, the volume of the prescribed substance with distilled water is increased to 5 ml, and by the intern, who is unaware of the type of drug prescribed, it is poured into the syringes containing the intervention drug under the child's tongue. To be swallowed with a little pause in the mouth. Intervention 3: Intervention group: The third group: Dexmedetomidine 4 micrograms per kilogram orally (dexmedetomidine made by Elixir Company - Iran) after calculating the amount of drug based on the weight of the child, to equalize and create an acceptable taste of one ml of 20% dextrose solution to the intervention drug is calculated Is added for each patient, and finally, to match the groups, the volume of the prescribed substance with distilled water is increased to 5 ml, and by the intern, who is unaware of the type of drug prescribed, it is poured into the syringes containing the intervention drug under the child's tongue. To be swallowed with a little pause in the mouth. Yes - There is a plan to make this available What will be shared: After the publication of the article, confidential information such as patient and hospital details, etc. will be deleted and other information will be provided to researchers. When: After publishing the article To whom: Medical specialists Conditions: Medical professionals can access the data for research purposes. Where to obtain: Email the corresponding author How to obtain: Official and academic email to the corresponding author Comments:
public Hesameddin Modir
Vali-ye-Asr Hospital of Arak, Hazrat Valiasr Square
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 he_modir@arakmu.ac.ir Arak University of Medical Sciences scientific Hesameddin Modir
Vali-ye-Asr Hospital of Arak, Hazrat Valiasr Square
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 he_modir@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age 2 to 7 years Weight between 10 and 30 kg ASA I or II Candidate for elective surgery except for fractures Absence of any fracture operation No history of allergies Absence of liver, kidney and cardiopulmonary disorders Lack of long-term use of anticonvulsant drugs, sleep disorders Absence of speech or communication problems Absence of gastrointestinal disorders (due to oral administration of drugs) The duration of surgery is less than 120 minutes Consent of parents and guardians of the child 2 years 10 years Both Any unpredictable complications around the operation that affect the variables being evaluated Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: The first group: midazolam half mg / kg (midazolam ampoule made by Caspian Tamin Company Rasht - Iran) after calculating the amount of drug based on the weight of the child, to equalize and create an acceptable taste of one ml of 20% dextrose solution to the intervention drug is calculated Is added for each patient, and finally, to match the groups, the volume of the prescribed substance with distilled water is increased to 5 ml, and by the intern, who is unaware of the type of drug prescribed, it is poured into the syringes containing the intervention drug under the child's tongue. To be swallowed with a little pause in the mouth. Intervention group: The second group: Ketamine 5 mg/kg (ketamine consumed by Rotex Medica - Germany) after calculating the amount of drug based on the weight of the child, to equalize and create an acceptable taste of one ml of 20% dextrose solution to the intervention drug is calculated Is added for each patient, and finally, to match the groups, the volume of the prescribed substance with distilled water is increased to 5 ml, and by the intern, who is unaware of the type of drug prescribed, it is poured into the syringes containing the intervention drug under the child's tongue. To be swallowed with a little pause in the mouth. Intervention group: The third group: Dexmedetomidine 4 micrograms per kilogram orally (dexmedetomidine made by Elixir Company - Iran) after calculating the amount of drug based on the weight of the child, to equalize and create an acceptable taste of one ml of 20% dextrose solution to the intervention drug is calculated Is added for each patient, and finally, to match the groups, the volume of the prescribed substance with distilled water is increased to 5 ml, and by the intern, who is unaware of the type of drug prescribed, it is poured into the syringes containing the intervention drug under the child's tongue. To be swallowed with a little pause in the mouth. Sedation score. Timepoint: The observation sedation score is measured before the medication is prescribed (midazolam, ketamine, and dexmedetomidine) and then when the child is separated from the parents. Method of measurement: Determine the sedation score by observing based on scoring from 1 to 5 based on the table from 1 to 5, respectively: agitated, alert, calm, drowsy and asleep. Ease of separation score. Timepoint: When separating children from their parents. Method of measurement: Determining the ease of separation score by observation based on scoring from 1 to 4 according to the table from 1 to 4, respectively: unafraid and cooperative - slight fear or crying quiet with assurance - moderate fear, crying not quiet with assurance - crying, need for restraint. Acceptance of drug. Timepoint: When inducing anesthesia inside the operating room. Method of measurement: Children are transported into the operating room and then inhaled anesthesia with a mask is induced in all groups using soufflore gas (4-8%). The acceptance rate of induction of anesthesia is determined based on the scoring of the table. Respectively from 1 to 3: refused to accept - accept with difficulty - accept without complaining. Mean blood pressure. Timepoint: Under monitoring from 30 minutes before anesthesia, every 5 minutes from the time of sedation until induction of anesthesia, every 15 minutes throughout the operation and in recovery until full awakening, re-measured in case of side effects up to 24 hours after surgery. Method of measurement: arm sphygmomanometer In millimetres of mercury. Heart rate. Timepoint: Under monitoring from 30 minutes before anesthesia, every 5 minutes from the time of sedation until induction of anesthesia, every 15 minutes throughout the operation and in recovery until full awakening, re-measured in case of side effects up to 24 hours after surgery. Method of measurement: Cardiac monitoring and finger pulse oximetery. Arterial oxygen saturation. Timepoint: Under monitoring from 30 minutes before anesthesia, every 5 minutes from the time of sedation until induction of anesthesia, every 15 minutes throughout the operation and in recovery until full awakening, re-measured in case of side effects up to 24 hours after surgery. Method of measurement: Finger pulse oximetery. Side effects (nausea and vomiting, hypotension, bradycardia). Timepoint: In the postoperative period, patients will be monitored and followed for 24 hours for possible side effects. Method of measurement: Nausea and vomiting with observation and examination - Hypotension (low blood pressure more than 20% of primary blood pressure) with arm sphygmomanometer - Bradycardia (heart rate less than 70 beats per minute) with heart monitoring and finger pulse oximetry. Time to get Aldrete Score 8 and above. Timepoint: One turn (after the end of the operation until reaching the Aldrete score 8 and above). Method of measurement: In minutes from the end of the operation until reaching the Aldrete score of 8 and above In the recovery room according to the table The Modified Aldrete Postanesthesia Score in pediatric. Arak University of Medical Sciences Approved 2021-09-05 Ethics committee of Arak University of Medical Sciences Sardasht, Basij Square, University of Medical Sciences, University Complex of the Holy Prophet (PBUH), Deputy of Research and Technology Arak Markazi Iran (Islamic Republic of)