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

Phase 2

Completed

• Conditions: Anxiety
• Interventions: Drug: Dexmedetomidine; Drug: paracetamol

• Registration Number: NCT04949477
• Lead Sponsor: Benha University

Brief 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.

Study Timeline

• Study First Submitted: 2021-06-25
• Study Start: 2021-07-01
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-02
• Primary Completion: 2021-12-01
• Study Completion: 2022-01-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• The patients who are clinically free or with controlled medical condition [ASA I or ASA II].
• Age between 2 to 8 years.

Exclusion Criteria

• ASA III or ASA IV.
• Age greater than 8 years.
• Parents' refusal to participate in the study.
• Patients with obstructive sleep apnea.
• Patients with known allergy or hypersensitivity reaction to any of the drugs used in the study.
• Patients with nasal infection or nasal pathology.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (D)	Dexmedetomidine	The patient will receive intranasal dexmedetomidine.
Group (P)	paracetamol	The patient will receive paracetamol orally.

Primary Outcome Measures

Name	Time	Method
Preoperative anxiety	After 50 minutes of drug administration.	Modified Yale preoperative anxiety score (m-Yale PAS) before intravenous catheterization. In m-Yale PAS, anxiety was assessed based on their activities, (1-4) emotional expression, (1-4) Vocalization, (1-6) state of arousal (1-4) and interaction with family members.(1-4) The minimum of score is five (minimum anxiety) and the maximum is 22 which means severe anxiety.

Trial Locations

Locations (1)

Banha Faculity of Medicine; 🇪🇬 Banhā, Elqalyoubea, Egypt