Skip to main content
OpenTrials
Completed

NCT Number: NCT04678050

Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ain Shams University

Cairo, Abassia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA-I children,
  • aged 5-10 years-old,
  • requiring dental pulp therapy

Exclusion criteria

  • ASA class ≥ II;
  • previous experience with GA or Conscious sedation (CS);
  • dental treatment expected to exceed 45 minutes;
  • history of allergy to local anesthetics, Dex, propofol, ketamine, eggs, or soya;
  • respiratory tract infections

Treatment and study plan

Ketamine/ propofol

Drug

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.

Other names: Ketofol

Dexmedetomidine

Drug

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

Other names: precedex

Primary outcomes

  1. the Number of interruptions

    Time frame: through study completion, an average of 3 month

    the Number of interruptions that occurred during the procedure

Secondary outcomes

  1. total dose of rescue drug

    Time frame: through study completion, an average of 3 month

    total dose of rescue propofol in mg

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Dexmedetomidine Compared to Ketofol for Sedation in Paediatrics Undergoing Dental Procedures: a Comparative Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2020
Registry last updated
Aug 5, 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.

Published trials that share one or more normalized conditions with this study.