Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication on the Occurrence of Postoperative Respiratory Adverse Events

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-04

Study Completion Date

2024-10-10

Brief Summary

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The aim of this study is to investigate the effect of addition of intranasal ketamine to midazolam compared to midazolam alone as a premedication on the occurrence of PRAEs

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Detailed Description

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Perioperative respiratory adverse events (PRAEs) are the most common complication during pediatric anesthesia furthermore, most children presenting for AT have sleep-disordered breathing and obstructive sleep apnea syndrome (OSAS) caused by tonsillar hypertrophy which could aggravate the PRAEs specially with the use of the conventional sedatives as a premedication. A recent randomized controlled trial has shown that more than 50% of children premedicated with midazolam had experienced PRAEs . Midazolam and ketamine are commonly used as preoperative sedative drugs for pediatric populations. Ketamine is a safe and widely used sedative and analgesic in the pediatric emergency department (ED) with less profound effects on the upper airway and respiratory muscles. Intranasal ketamine administration is well tolerated and without serious adverse effects. The addition of ketamine to midazolam as a preoperative sedation to reduce the occurrence of PRAEs was not investigated before in children undergoing AT. The authors hypothesize that combination of ketamine to midazolam could offer optimum sedation condition while reducing the occurrence of PRAEs in children undergoing AT.

Conditions

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Tonsillectomy Adenoidectomy Drug-Related Side Effects and Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Children will be randomly assigned to 2 groups: the midazolam group will receive intranasal midazolam (0.1 mg/kg), and the midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg) for premedication

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The drug will be prepared by an anesthesia nurse who will not be involved in the study. The active drug will be administered by a fully trained anesthesiologist and Clear definitions of the respiratory adverse events will be provided to the involved anesthetist. All researchers directly involved in the study will be blinded to the drug which will be administered

Study Groups

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(Group M)

The midazolam group will receive intranasal midazolam (0.1 mg/kg)

Group Type ACTIVE_COMPARATOR

The midazolam group

Intervention Type DRUG

The midazolam group will receive intranasal midazolam (0.1 mg/kg)

(Group MK)

Midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg)

Group Type EXPERIMENTAL

The midazolam ketamine group

Intervention Type DRUG

the midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg)

Interventions

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The midazolam group

The midazolam group will receive intranasal midazolam (0.1 mg/kg)

Intervention Type DRUG

The midazolam ketamine group

the midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children both sexes male and female.
* Age from 3 to 12 years old.
* ASA grade I, II.
* undergoing elective AT procedures.

Exclusion Criteria

* Congenital heart diseases (cyanotic and a cyanotic).
* Congenital syndromes affecting airway anatomy such as Pierre-Robin syndrome and Down syndrome.
* Severe lung diseases affecting either lung tissue such as pulmonary cystic fibrosis and idiopathic pulmonary fibrosis or affecting lung circulation such as pulmonary hypertension with marked limitation of Physical activity or inability to carry out any physical activity according to NHYA classification.
* Recent upper respiratory tract infection (less than two weeks).
* Neuromuscular diseases including cerebral palsy and epilepsy.

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No