An interventional study of Group K:nebulized ketamine group and Group D:dexmedetomidine group in Dexmedetomidine, Adenotonsillectomy and Midazolam, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
The aim of this study is to compare between 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.
Primary outcome:
Secondary outcomes:
Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group K: Patients will receive nebulized ketamine 2 mg kg -1
Drug: Group K:nebulized ketamine group
Group D: Patients will receive dexmedetomidine 2 mcg kg -1
Drug: Group D:dexmedetomidine group
(Group M): Patients will receive midazolam 0.2 mg kg -1
Drug: Group M: midazolam group
Patients will receive nebulized ketamine 2 mg kg -1
Patients will receive dexmedetomidine 2 mcg kg -1
Patients will receive midazolam 0.2 mg kg -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.
Time frame: 30 min after drug administration
Parental separation anxiety scale
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 .
Time frame: 2 hours
Plan to share: Yes — It will be available when it needed
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Tanta University