Intranasal Dexmedetomidine Versus Oral Paracetamol as a Pre-anaesthetic Medication in Pediatric Age Group Undergoing Adenotonsillectomy: A Randomised Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Dexmedetomidine
- Conditions
- Anxiety
- Sponsor
- Benha University
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Preoperative anxiety
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Fatma Ahmed Abdel Fatah
Lecturer
Benha University
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.
Arms & Interventions
Group (D)
The patient will receive intranasal dexmedetomidine.
Intervention: Dexmedetomidine
Group (P)
The patient will receive paracetamol orally.
Intervention: paracetamol
Outcomes
Primary Outcomes
Preoperative anxiety
Time Frame: 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.