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

Sponsor

Kasr El Aini Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06122948

Collaborator

(none)

200

Enrollment

Location

Arms

11.7

Anticipated Duration (Months)

17.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Tonsillectomy Adenoidectomy Drug-Related Side Effects and Adverse Reaction	Drug: The midazolam group Drug: The midazolam ketamine group	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 premedicationChildren 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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

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

Actual Study Start Date :

Sep 10, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

The incidence of any perioperative respiratory adverse events (PRAEs) [8 hours]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 12 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo university hospitals, kasralainy	Cairo		Egypt	11559

Sponsors and Collaborators

Kasr El Aini Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Khaled Abdelfattah Abdallah Sarhan, principal investigator, Asst. professor of anesthesia, Cairo university, Kasr El Aini Hospital

ClinicalTrials.gov Identifier:

NCT06122948

Other Study ID Numbers:

MD-227-2023

First Posted:

Nov 8, 2023

Last Update Posted:

Nov 9, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Khaled Abdelfattah Abdallah Sarhan, principal investigator, Asst. professor of anesthesia, Cairo university, Kasr El Aini Hospital

midazolam

ketamine

tonsillectomy

respiratory adverse events

Additional relevant MeSH terms:

Midazolam

Ketamine

Study Results

No Results Posted as of Nov 9, 2023