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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: paracetamol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group (D)<br>The patient will receive intranasal dexmedetomidine. | Drug: Dexmedetomidine<br>* the patient will receive intranasal dexmedetomidine at a dose of 1 μg/kg to the patient 45 min. before the procedure.<br>* Other names: precedex;|
| Active Comparator: Group (P)<br>The patient will receive paracetamol orally. | Drug: paracetamol<br>* 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.<br>* Other names: cetal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Paracetamol, Preoperative anxiety