NCT04949477

Intranasal Dexmedetomidine Versus Oral Paracetamol as a Pre-anaesthetic Medication in Pediatric Age Group

Intranasal Dexmedetomidine Versus Oral Paracetamol as a Pre-anaesthetic Medication in Pediatric Age Group Undergoing Adenotonsillectomy: A Randomised Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Accepted

Summary

Pre-operative anxiety is a major problem in children because it produces undesired results on induction and postoperative outcome. Dexmedetomidine is a highly specific alpha 2 adrenergic receptor agonist. Studies suggest that Dexmetomidine administration is safe as it is less invasive and have a short half-life. Paracetamol is a potent physical pain killer. It also reduces psychological reactivity and blunts physical and social pain. Adenotonsillectomy is one of the most common surgeries performed in pediatric age groups, so it is important to reduce pre-operative anxiety in those children.

Detailed description

Pre-operative anxiety is a major problem in children because it produces undesired results on induction and postoperative outcome. Dexmedetomidine is a highly specific alpha 2 adrenergic receptor agonist. Studies suggest that Dexmetomidine administration is safe as it is less invasive and have a short half-life. Paracetamol is a potent physical pain killer. It also reduces psychological reactivity and blunts physical and social pain. Adenotonsillectomy is one of the most common surgeries performed in pediatric age groups, so it is important to reduce pre-operative anxiety in those children. The objective of this descriptive study is to compare the efficacy of dexmedetomidine and paracetamol premedication, measuring the degree of anxiety in the children prepared for adenotonsillectomy when they are separated from their parents.

Conditions

• Anxiety

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	the patient will receive intranasal dexmedetomidine at a dose of 1 μg/kg to the patient 45 min. before the procedure.
DRUG	paracetamol	the patient will receive paracetamol orally \[Rx paracetamol 250 mg/ml\] at a dose of 20 mg/kg given to the patient 45 min before the procedure by drinking.

Timeline

• Start date: 2021-07-01
• Primary completion: 2021-12-01
• Completion: 2022-01-01
• First posted: 2021-07-02
• Last updated: 2022-05-06

Locations

1 site across 1 country: Egypt