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OpenTrials
Completed

NCT Number: NCT06466915

Propofol vs. Nasal Dexmedetomidine in Pediatric Agitation and Delirium

Dental pain and anxiety are quite common in pediatric patients. However, due to children's inability to express their fears and lack of knowledge about the procedures to be performed, these symptoms have often been misunderstood and inadequately treated in pediatric settings. Children have consistently experienced high rates of emergence anxiety during the recovery process after general anesthesia. Emergence anxiety can be harmful to the patient, leading to bleeding at the surgical site, displacement of intravenous catheters, parental anxiety, additional care needs, and delays in hospital discharge. Inhalation anesthetics are preferred for pediatric surgeries because they promote faster recovery. However, inhalation anesthetics often lead to a high rate of emergence anxiety, ranging from 25% to 80% depending on the scoring scale used, the child's age, and the type of surgery performed. Additional sedative or analgesic drugs, such as midazolam, dexmedetomidine, or propofol, have been used to prevent emergence anxiety.

Dexmedetomidine is a selective α2-agonist with sedative and analgesic effects, but it can cause mild respiratory depression. Numerous studies have shown that intranasal dexmedetomidine is more effective than other adjunctive drugs. It has been found to be beneficial in reducing emergence anxiety during pediatric anesthesia with minimal blood pressure or respiratory depression. However, although intranasal dexmedetomidine initially has relatively rapid absorption, the absorption process may take longer compared to intravenous administration, implying that the child's hemodynamic status is more stable and a longer effective absorption time may have a clinical advantage in preventing emergence anxiety.

The aim of this study is to compare and investigate the effectiveness of nasal dexmedetomidine and intravenous propofol applications used to reduce agitation in pediatric cases following extubation in clinical practice.

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Key information

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ahmed Uslu

Ankara, Çankaya, 06490, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ASA 1-2

Exclusion criteria

  • Cardiac disease,
  • Psychiatric disease,
  • Coronary artery disease,
  • Long-term sedative drug use,
  • Pulmonary disease,
  • Known allergy to planned drugs

Treatment and study plan

Dexmedetomidine

Drug

Group Dex received 1 mcg/kg of dexmedetomidine intra-nasal 10 minutes before the surgical procedure ended.

Propofol

Drug

Group Pofol received 1 mg/kg propofol IV before the extubation.

Primary outcomes

  1. Agitation-Delirium

    Time frame: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.

    It will be evaluated with a Pediatric Anesthesia Emergence Delirium Scale.

  2. Behavioral pain assessment

    Time frame: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.

    It will be evaluated with a The Face, Legs, Activity, Cry, and Consolability Scale.

Secondary outcomes

  1. Nausea-vomiting

    Time frame: 0, 5, 10, 15, 20, 25, 30. minutes after extubation.

    It will be evaluated by visual analogue scale.

  2. Rapid recovery

    Time frame: 30 minutes after extubation.

    It will be evaluated with a Modified Aldrete Score.

Sponsors and collaborators

Lead sponsor

Baskent University Ankara Hospital

Other

Registry information

Official study title

Comparison of the Use of Propofol and Nasal Dexmedetomidine in the Management of Agitation and Delirium in Patients Undergoing Dental Procedures

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 20, 2024
Registry last updated
Jul 7, 2026

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.