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

Tonsillectomy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122948
• Other study ID #: MD-227-2023
• Status: Recruiting
• Phase: Phase 3
• Start date: September 10, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: November 2023
• Source: Kasr El Aini Hospital
• Contact: Khaled Sarhan, MD
• Phone: +201020067816
• Email: khaled.sarhan[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoidectomy
• Drug-Related Side Effects and Adverse Reactions
• Tonsillectomy

Intervention

Drug:
• The midazolam group
The midazolam group will receive intranasal midazolam (0.1 mg/kg)
• The midazolam ketamine group
the midazolam ketamine group will receive intranasal midazolam (0.1mg/kg) and ketamine (3mg/kg)

Locations

Country	Name	City	State
Egypt	Cairo university hospitals, kasralainy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative pain score	• Postoperative pain score using (Wong-Baker Pain Scale)	8 hours
Secondary	Sedation success rate	• Sedation success rate (score of 3 or 4 is considered successful sedation) using Funk score	8 hours
Secondary	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