Nebulized Dexmedetomidine, Ketamine, or Midazolam in Children Undergoing Adenotonsillectomy

May 1, 2026 updated by: Mohamed Mostafa Mohamed Abd Elfatah Elrefaie, Tanta University

Comparison of Nebulized Dexmedetomidine, Ketamine, or Midazolam for Premedication in Children Undergoing Adenotonsillectomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group K :nebulized ketamine group
Group K: Patients will receive nebulized ketamine 2 mg kg -1
Drug: Group K:nebulized ketamine group
Patients will receive nebulized ketamine 2 mg kg -1
Experimental: Group D: dexmedetomidine group
Group D: Patients will receive dexmedetomidine 2 mcg kg -1
Drug: Group D:dexmedetomidine group
Patients will receive dexmedetomidine 2 mcg kg -1
Experimental: Group M:midazolam group
(Group M): Patients will receive midazolam 0.2 mg kg -1
Drug: Group M: midazolam group
Patients will receive midazolam 0.2 mg kg -1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A five-point sedation score on arrival in the operating room
Time Frame: 30 min after drug administration
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental separation anxiety scale
Time Frame: 2 hours
parental separation will be assessed by a four-point parental separation anxiety scale (PSAS) as follows: 1= easy separation, 2= whimpers, but is easily reassured, not clinging, 3= cries and cannot be easily reassured, but not clinging to parents, and 4= crying and clinging to parents. PSAS scores of 1 and 2 signified acceptable separation whereas scores of 3 and 4 will be classified as difficult separation .
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2024

Primary Completion (Actual)

November 30, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

April 26, 2026

First Submitted That Met QC Criteria

April 26, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 36264MS748/11/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It will be available when it needed

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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