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

NCT04949477 | Completed Phase 2

• 1 other identifier: 8-5-2021
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Dexmedetomidine; Paracetamol; Preoperative anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Group (D)

ACTIVE COMPARATOR

The patient will receive intranasal dexmedetomidine.

Drug: Dexmedetomidine

Group (P)

ACTIVE COMPARATOR

The patient will receive paracetamol orally.

Drug: paracetamol

Interventions

Dexmedetomidine DRUG

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

Also known as: precedex

Group (D)

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.

Also known as: cetal

Group (P)

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The patients who are clinically free or with controlled medical condition \[ASA I or ASA II\].
• Age between 2 to 8 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Banha Faculity of Medicine

Banhā, Elqalyoubea, 13511, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Dexmedetomidine; Acetaminophen

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 2, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

EG (1)