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

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

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

Study Overview

• Status: Recruiting
• Conditions: Tonsillectomy; Adenoidectomy; Drug-Related Side Effects and Adverse Reaction
• Intervention / Treatment: Drug: The midazolam group; Drug: The midazolam ketamine group

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Khaled Sarhan, MD; Phone Number: +201020067816; Email: khaled.sarhan@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11559
    • Recruiting
    • Cairo university hospitals, kasralainy
    • Contact: Khaled Sarhan, MD; Phone Number: +201020067816; Email: khaled.sarhan@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: (Group M); The midazolam group will receive intranasal midazolam (0.1 mg/kg)	Drug: The midazolam group; The midazolam group will receive intranasal midazolam (0.1 mg/kg)
Experimental: (Group MK); Midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg)	Drug: The midazolam ketamine group; the midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of any perioperative respiratory adverse events (PRAEs)	the incidence of any PRAEs (Perioperative respiratory adverse events (PRAEs) which are manifested as minor (oxygen desaturation (SaO2 less than 95% for 10 seconds) or coughing) and major as (bronchospasm, laryngospasm, airway obstruction, stridor or hypoxia (oxygen desaturation less than 90%)) among midazolam versus midazolam ketamine groups.	8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score	• Postoperative pain score using (Wong-Baker Pain Scale)	8 hours
Sedation success rate	• Sedation success rate (score of 3 or 4 is considered successful sedation) using Funk score	8 hours
Postoperative emergence delirium	• Postoperative emergence delirium, a total Postoperative emergence delirium PAED score≥ 10 will be considered indicative of the presence of ED using (PAED scale	8 hours

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: midazolam; ketamine; tonsillectomy; respiratory adverse events
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Ketamine; Midazolam
• Other Study ID Numbers: MD-227-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No