Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics

Status Completed

Clinical Trial Summary

Dental fear and anxiety remain common problems that should be managed by both the dentist and the anesthetist. The currently available evidence for safe and effective sedative drugs for children undergoing the dental procedure is scarce The aim of this study was to compare the safety and efficacy of intravenous ketofol versus dexmedetomidine (Dex) as premedications a sedative in anxious children undergoing dental pulp therapy

Clinical Trial Description

This double-blind, parallel-group, randomized clinical study will recruiter anxious children who will undergo dental pulp therapy. The study participants will be allocated into two equal groups. Subjects in group I will receive ketofol solution (ketamine/propofol mixture, each mL contains 5 mg of ketamine plus 10 mg of propofol). A loading dose of 0.125 mL/kg will be administered intravenously (IV) over 10 min, followed by maintenance infusion at a rate of 0.05-0.125 mL/kg/h. Subjects in group II will receive the Dex solution (4 µg/mL). A loading dose of 2 µg/kg will be administered IV over 10 min, followed by a maintenance infusion of 0.1-1 µg/kg/h. Non-invasive blood pressure (mean ABP), peripheral oxygen saturation, heart rate, and respiratory rate will be assessed at baseline, at 2 minutes, then at 5 minutes intervals till 60 minutes. Ramsay sedation and Aldrete's recovery rating scores will be assessed before, during, and after the procedure. ;

Study Design

Related Conditions & MeSH terms

Vital Signs

Clinical Trial Details

NCT number	NCT04678050
Study type	Interventional
Source	Ain Shams University
Contact
Status	Completed
Phase	Phase 1
Start date	October 10, 2020
Completion date	December 30, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05908045` - Have Physical Therapists Attitudes and Beliefs Towards Vital Assessment Changed Following the COVID-19 Pandemic?
Enrolling by invitation	`NCT05975658` - WIReD: Wireless Interstage Remote Device Study
Completed	`NCT03143062` - The National Early Warning Score: Preceding Dynamics in the Score for Those Who Suffer an In-hospital Cardiac Arrest
Completed	`NCT03179267` - Detection of Deterioration by SNAP40 Versus Standard Monitoring in the ED	N/A
Not yet recruiting	`NCT05023356` - Non-contact Vital Signs Monitoring in Anesthesia
Recruiting	`NCT05970614` - The Effect of Eye Masks and Earplugs In Intensive Care Unit Patients	N/A
Completed	`NCT01448161` - A Machine Learning Approach to Continuous Vital Sign Data Analysis
Recruiting	`NCT05013411` - Rethinking Observations in Mental Health
Not yet recruiting	`NCT04976907` - Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement
Completed	`NCT01157832` - Evaluation of the Acute Effect of Water-Pipe Smoking on the Respiratory System	N/A
Completed	`NCT04003662` - Vital Sign Comparison Between Lifelight and Standard of Care - Development
Recruiting	`NCT05241483` - Remote Patient Monitoring and Detection of Possible Diseases With Artificial Intelligence Telemedicine System
Not yet recruiting	`NCT04627766` - Validation of Continuous Monitoring of Vital Signs in Children With a Connected Patch	N/A
Completed	`NCT04997694` - Effect of Preoperative Active Warming and Passive Warming Methods on Perioperative Hypothermia	N/A
Active, not recruiting	`NCT04935190` - Comparison of Resting Heart and Respiratory Rate Measurements Acquired by Contactless Radar Sensors, Electrocardiography, and Capnography
Completed	`NCT04935723` - The Effects of Reiki on Abdominal Surgery Patients' Anxiety, Fear, Postoperative Pain and Life Findings	N/A
Completed	`NCT05131620` - Virtual Reality and Acupressure Applications; Effect on Pain, Anxiety, Vital Signs and Comfort	N/A
Completed	`NCT02524470` - Vital Signs Patch Early Feasibility and Usability Study v1.0	N/A
Completed	`NCT05027659` - The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy	N/A
Not yet recruiting	`NCT05451875` - Comparison of Continuous Non-invasive All Vital Signs Monitoring Devices With Invasive Gold Standard for Children