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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04949477
Enrollment
86
Registered
2021-07-02
Start date
2021-07-01
Completion date
2022-01-01
Last updated
2022-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

Dexmedetomidine, Paracetamol, Preoperative anxiety

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.

Interventions

DRUGDexmedetomidine

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

DRUGparacetamol

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.

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Preoperative anxietyAfter 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026