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NCT Number: NCT04949477

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

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.

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Key information

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Banha Faculity of Medicine

Banhā, Elqalyoubea, 13511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: precedex

Paracetamol

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.

Other names: cetal

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 2, 2021
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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