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

Kasr El Aini Hospital

Status and phase: Completed; Phase 3

Conditions: Adenoidectomy; Drug-Related Side Effects and Adverse Reaction; Tonsillectomy

Treatments: Drug: The midazolam group; Drug: The midazolam ketamine group

Study type: Interventional

Funder types: Other

Identifiers

NCT06122948

MD-227-2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

(Group M)

Active Comparator group

Description:

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

Treatment:

Drug: The midazolam group

(Group MK)

Experimental group

Description:

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

Treatment:

Drug: The midazolam ketamine group