Nebulized Dexmedetomidine, Ketamine, or Midazolam in Children Undergoing Adenotonsillectomy

NCT07564037 | Completed

• 1 other identifier: 36264MS748/11/24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare between nebulized dexmedetomidine, ketamine, or midazolam for premedication in children undergoing adenotonsillectomy. Primary outcome:

• A five-point sedation score on arrival in the operating room 30 min after drug administration. Secondary outcomes:
• Parental separation anxiety scale.
• Medication and mask acceptance scales.
• Hemodynamic variables.
• Recovery time.
• Postoperative face, legs, activity, cry, and consolability (FLACC) scale.
• Emergence Agitation scale.
• Adverse effects.

Conditions

Dexmedetomidine; Adenotonsillectomy; Midazolam; Children

Keywords

Midazolam; Nebulized; Dexmedetomidine; Adenotonsillectomy; Children

Outcome Measures

Primary Outcomes (1)

• A five-point sedation score on arrival in the operating room

  Sedation level will be assessed at the same time points mentioned above using a five-point sedation scale score as follows: 1= agitated, 2= alert, 3= calm, 4= drowsy, and 5=asleep . A score ≥ 3 will be considered as acceptable sedation.

  30 min after drug administration

Secondary Outcomes (1)

• Parental separation anxiety scale

  At the end of the operation (2hours)

Study Arms (3)

Group K :nebulized ketamine group

EXPERIMENTAL

Group K: Patients will receive nebulized ketamine 2 mg kg -1

Drug: Group K:nebulized ketamine group

Group D: dexmedetomidine group

EXPERIMENTAL

Group D: Patients will receive dexmedetomidine 2 mcg kg -1

Drug: Group D:dexmedetomidine group

Group M:midazolam group

EXPERIMENTAL

(Group M): Patients will receive midazolam 0.2 mg kg -1

Drug: Group M: midazolam group

Interventions

Group K:nebulized ketamine group DRUG

Patients will receive nebulized ketamine 2 mg kg -1

Group K :nebulized ketamine group

Group D:dexmedetomidine group DRUG

Patients will receive dexmedetomidine 2 mcg kg -1

Group D: dexmedetomidine group

Group M: midazolam group DRUG

Patients will receive midazolam 0.2 mg kg -1

Group M:midazolam group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 3-7 years.
• Both sexes.
• American society of anesthesiologists (ASA) physical status (I-II).
• Children undergoing adenotonsillectomy.

You may not qualify if:

• Patients with known allergy to the study drugs.
• Significant organ dysfunction.
• Cardiac dysrhythmia.
• Congenital heart disease.
• Use of psychotropic medication, and mental retardation

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical ICU and Pain Medicine

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 4, 2026
• Study Start: November 30, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 4, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)