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

NCT ID: NCT04949477

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-01-01

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group (D)

The patient will receive intranasal dexmedetomidine.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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

Group (P)

The patient will receive paracetamol orally.

Group Type: ACTIVE_COMPARATOR

paracetamol

Intervention Type: DRUG

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.

Interventions

Dexmedetomidine

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

precedex; cetal

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Ahmed Abdel Fatah

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Banha Faculity of Medicine

Banhā, Elqalyoubea, Egypt

Countries

Egypt

Other Identifiers

8-5-2021

Identifier Type: -

Identifier Source: org_study_id