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Completed

NCT Number: NCT07564037

Nebulized Dexmedetomidine, Ketamine, or Midazolam in Children Undergoing Adenotonsillectomy

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

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Key information

Conditions

Dexmedetomidine Adenotonsillectomy Children Midazolam

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group K:nebulized ketamine group

Drug

Patients will receive nebulized ketamine 2 mg kg -1

Group D:dexmedetomidine group

Drug

Patients will receive dexmedetomidine 2 mcg kg -1

Group M: midazolam group

Drug

Patients will receive midazolam 0.2 mg kg -1

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 .

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 4, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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