Clinical trial

Nebulized Dexmedetomidine VS Oro-dispersible Film Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Outpatient Surgeries: A Randomized Controlled Double-blinded Study

Name

FWA 000017585

Description

The goal of this clinical trial is to compare between the effect of nebulized dexmedetomidine and the effect of oral dispensable film (ODF) melatonin in controlling perioperative anxiety and post operative emergence agitation and their effect on the overall surgical experience.in pediatric patients undergoing day case surgery.

Trial arms

Trial start

2023-03-15

Estimated PCD

2023-09-30

Trial end

2023-09-30

Status

Recruiting

Treatment

Dexmedetomidine

receive placebo ODF and 3 µ/kg nebulized dexmedetomidine (Precedex™ rxlist) prepared in 0.9% normal saline to a final volume of 3ml. Nebulization was performed using a wall nebulizer and wall oxygen source on 4 l/min.

Arms:

group D

Other names:

Precedex™ rxlist

Melatonin

will receive placebo nebulizer and 0.4mg/kg of ODF melatonin (metacyst ™ nerhadou) orally allowing the film to dissolve in the patients Oro mucosal lining

Arms:

group M

Other names:

metacyst ™ nerhadou

Placebo

placebo ODF and 0.9% normal saline nebulizer

Arms:

group C

Other names:

normal saline

Size

Primary endpoint

perioperative anxiety

during the patient separation from the caregiver just as the child is going to the operating theater

Eligibility criteria

Inclusion Criteria: * Patients of American Society of Anesthesiologists (ASA) physical status I \& II * both genders, * ≥ 2 to 10 years, * scheduled for elective day case surgery under general anesthesia Exclusion Criteria: * parents' refusal for participation in the study * ASA III and VI patients with history of chronic illness * runny nose or upper respiratory tract infection * Emergency surgeries with hemodynamic instability * history of allergic reaction to dexmedetomidine or melatonin * History of prematurity * developmental delay * central nervous system disorder, * mental retardation, * neurological or psychiatric illness that may be associated with anxiety and agitation (cerebral palsy, seizure, separation anxiety disorder, ADHD etc.). * treatment with anticonvulsants and sedatives

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2023-03-13

1 organization

2 products

1 drug

2 indications

Organization

Nada Moahmed Aboelrouse

Product

Indication

Indication

Product

Drug