Adenotonsillectomy, Children, Dexmedetomidine, Midazolam
Conditions
Keywords
Midazolam, Nebulized, Dexmedetomidine, Adenotonsillectomy, Children
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.
Interventions
DRUGGroup K:nebulized ketamine group
Patients will receive nebulized ketamine 2 mg kg -1
DRUGGroup D:dexmedetomidine group
Patients will receive dexmedetomidine 2 mcg kg -1
DRUGGroup M: midazolam group
Patients will receive midazolam 0.2 mg kg -1
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A five-point sedation score on arrival in the operating room | 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
| Measure | Time frame | Description |
|---|---|---|
| Parental separation anxiety scale | 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 . |
Countries
Egypt
Outcome results
None listed