Clinical trial NCT06122948: Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication on the Occurrence of Postoperative Respiratory Adverse Events
Official title: Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication in Children Undergoing Tonsillectomy and Adenoidectomy on the Occurrence of Postoperative Respiratory Adverse Events: a Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tonsillectomy
Adenoidectomy
Drug-Related Side Effects and Adverse Reaction
Keywords: midazolam
ketamine
tonsillectomy
respiratory adverse events
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of any perioperative respiratory adverse events (PRAEs)
timeFrame: 8 hours
Secondary outcomes:
measure: Postoperative pain score
timeFrame: 8 hours
measure: Sedation success rate
timeFrame: 8 hours
measure: Postoperative emergence delirium
timeFrame: 8 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university hospitals, kasralainy
Study officials:
References: