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

NCT06122948 | Completed Phase 3

• 1 other identifier: MD-227-2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

midazolam; ketamine; tonsillectomy; respiratory adverse events

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative pain score

  8 hours

• Sedation success rate

  8 hours

• Postoperative emergence delirium

  8 hours

Study Arms (2)

(Group M)

ACTIVE COMPARATOR

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

Drug: The midazolam group

(Group MK)

EXPERIMENTAL

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

Drug: The midazolam ketamine group

Interventions

The midazolam group DRUG

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

(Group M)

The midazolam ketamine group DRUG

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

(Group MK)

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children both sexes male and female.
• Age from 3 to 12 years old.
• ASA grade I, II.
• undergoing elective AT procedures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo university hospitals, kasralainy

Cairo, 11559, Egypt

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, Asst. professor of anesthesia, Cairo university

Model Details: 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

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: November 4, 2023
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)