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IRCT20201220049777N1 IRCT 2020-12-31 Research Institute of Ophthalmology Intranasal midazolam/ketamine combination for preoperative sedation in pediatrics Intranasal midazolam alone versus midazolam/ketamine combination for preoperative sedation in pediatric patients undergoing ophthalmic procedures: A randomized controlled trial 2021-01-15 anticipated 46 Complete https://irct.ir/trial/53129 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will use the sequentially numbered, opaque sealed envelopes method. We will use envelopes that are impermeable to intense light, and the allocation sequence will be concealed from the physicians enrolling and assessing participants. To prevent subversion of the allocation sequence, the name and hospital admission number of the participant will be written on the envelope. Carbon paper will transfer the information onto the allocation card inside the envelope. Corresponding envelopes will be opened only after the enrolled participants complete all baseline assessments and it is time to allocate the intervention, Blinding description: Only participants will be blinded to the type of intervention. 2 Preoperative sedation in pediatric patients undergoing ophthalmic procedures.. Intervention 1: Intervention group 1: The patients will be given midazolam intranasally in a dose of 0.5 mg/kg. The drug will be administered 15 minutes prior to induction of anesthesia. Intervention 2: Intervention group 2: The patients will be given a combination of intranasal midazolam (0.25 mg/kg) and ketamine (1 mg/kg). The drugs will be administered 15 minutes prior to induction of anesthesia. Yes - There is a plan to make this available What will be shared: Intranasal midazolam and ketamine for preoperative sedation IPD set (all collected deidentified IPD). When: Beginning 6 months and ending 24 months following article publication To whom: Researchers from academic institutions whose proposal for the use of data has been approved by an independent review committee identified for this purpose. Conditions: For IPD meta-analysis. Where to obtain: From the PI. How to obtain: A proposal for the use of data to be submitted to the PI, then evaluated by an independent review committee identified for this purpose. Comments:
public Noha Osama
2 El Ahram Street
Giza Egypt 12557 +20 2 35718304 noha.a.osama22@gmail.com Research Institute of Ophthalmology scientific Noha Osama
2 El Ahram Street
Giza Egypt 12557 +20 2 35718304 noha.a.osama22@gmail.com Research Institute of Ophthalmology Egypt Children (male or female) aged from 3 to 7 years old ASA I or II Children with disability or special needs such as autism and Down syndrome Children who underwent multiple operative procedures Children with history of stormy anesthetic induction or emergence 3 years 7 years Both Anticipated difficult airways, such as facial deformity, cervical spine injury, or some syndromes (e.g. Pierre robin syndrome, Apert syndrome, and Teacher Collins syndrome). Increased risk of aspiration as in anatomical abnormalities, such as cleft palate and problems in the esophagus, neuromuscular diseases, and cerebral palsy. Central or obstructive sleep apnea. Previous allergy or adverse reaction to the used drugs. Treatment - Drugs Treatment - Drugs Intervention group 1: The patients will be given midazolam intranasally in a dose of 0.5 mg/kg. The drug will be administered 15 minutes prior to induction of anesthesia. Intervention group 2: The patients will be given a combination of intranasal midazolam (0.25 mg/kg) and ketamine (1 mg/kg). The drugs will be administered 15 minutes prior to induction of anesthesia. Preoperative level of sedation. Timepoint: 10 minutes after sedation is given. Method of measurement: 6-Point Pediatric Sedation State Scale. Postoperative agitation. Timepoint: at the time of patient recovery. Method of measurement: Emergence Agitation Scale. Easiness of separation. Timepoint: at the time of separation. Method of measurement: Separation and Induction Score. Oxygen saturation. Timepoint: every 5 minutes intraoperatively. Method of measurement: pulse oximetry. Pulse rate. Timepoint: every 5 minutes intraoperatively. Method of measurement: manually. Postoperative nausea and vomiting. Timepoint: 30 minutes after recovery. Method of measurement: clinical evaluation. Self-funded Approved 2020-11-08 Research Ethical Committee of the Research Institute of Ophthalmology 2 El Ahram Street Giza Cairo Egypt