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

Benha University

Status and phase: Completed; Phase 2

Conditions: Anxiety

Treatments: Drug: Dexmedetomidine; Drug: paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT04949477

8-5-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 2 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

Group (D)

Active Comparator group

Description:

The patient will receive intranasal dexmedetomidine.

Treatment:

Drug: Dexmedetomidine

Group (P)

Active Comparator group

Description:

The patient will receive paracetamol orally.

Treatment:

Drug: paracetamol