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Nebulized Dexmedetomidine VS ODF Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Day Surgery

NCT05766436 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-03-13

No results posted yet for this study

Summary

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.

Conditions

  • Anxiety Acute
  • Emergence Agitation

Interventions

DRUG

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.

DRUG

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

DRUG

Placebo

placebo ODF and 0.9% normal saline nebulizer

Sponsors & Collaborators

  • nada moahmed aboelrouse

    lead OTHER

Principal Investigators

  • Sohair Abbas, MD · Ain Shams University, Anesthesia department

  • Ramy Mahrose, MD · Ain Shams University, Anesthesia department

  • Wessam Zaher, MD · Ain Shams University, Anesthesia department

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05766436 on ClinicalTrials.gov