Comparison of Nebulized Dexmedetomidine, Ketamine, or Midazolam for Premedication in Children Undergoing Adenotonsillectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- A five-point sedation score on arrival in the operating room
Study Overview
Brief Summary
The aim of this study is to compare between nebulized dexmedetomidine, ketamine, or midazolam for premedication in children undergoing adenotonsillectomy.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group M:midazolam group
(Group M): Patients will receive midazolam 0.2 mg kg -1
Intervention: Group M: midazolam group (Drug)
Group K :nebulized ketamine group
Group K: Patients will receive nebulized ketamine 2 mg kg -1
Intervention: Group K:nebulized ketamine group (Drug)
Group D: dexmedetomidine group
Group D: Patients will receive dexmedetomidine 2 mcg kg -1
Intervention: Group D:dexmedetomidine group (Drug)
Outcomes
Primary Outcomes
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
- Parental separation anxiety scale(At the end of the operation (2hours))
Investigators
Mohamed Mostafa Mohamed Abd Elfatah Elrefaie
Resident in Anesthesiology, Surgical ICU and Pain Medicine
Tanta University