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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949477
• Other study ID #: 8-5-2021
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: May 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety

Intervention

Drug:
• Dexmedetomidine
the patient will receive intranasal dexmedetomidine at a dose of 1 µg/kg to the patient 45 min. before the procedure.
• 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.

Locations

Country	Name	City	State
Egypt	Banha Faculity of Medicine	Banha	Elqalyoubea

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative anxiety	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.	After 50 minutes of drug administration.