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NCT Number: NCT04509414

Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients

It is important to choose an appropriate analgesia/sedation technique in pediatric dental treatment. Premedication combined with intravenous anesthesia is often used in deep sedation technique for pediatric dental treatment and it's a routine in most hospitals. Deep sedation has its unique advantages such as avoiding the airway damage with an enhanced recovery.

Dexmedetomidine is suitable for intranasal mucosal administration as a premedication drug. It has been proved with several beneficial characteristics in other clinical procedures.

This study intends to further explore the characteristics of nasal dexmedetomidine as premedication in pediatric oral treatment under deep sedation.

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Key information

Conditions

Deep Sedation Dexmedetomidine

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • children in need of deep sedation for dental treatment aged 3-7 years.
  • anticipated operation time 1-2hours

Exclusion criteria

  • any known medical records with neural or mental disorder
  • any known medical records with severe systemic disorder
  • history of sedation drug administration in recent 1 months
  • any known allergic history of dexmedetomidine, midazolam or propofol
  • morbid obesity
  • history of OSAHS or acute respiratory infection in 2 weeks
  • other conditions which the attending considers to be unfit for the trial

Treatment and study plan

Dexmedetomidine

Drug

For dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated.

midazolam

Drug

For midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated.

Primary outcomes

  1. venipuncture acceptance

    Time frame: Day 0

    acceptance while starting the IV line, at most 2 tries

Secondary outcomes

  1. Observer's Assessment of Alertness/Sedation(MOAA/S) Score

    Time frame: Day 0

    sedation scoring with MOAA/S scale(from intranasal drug administration till discharge)

  2. remedial mask induction acceptance

    Time frame: Day 0

    acceptance of the mask induction（for those failed to start the IV before induction）

  3. propofol dosage

    Time frame: Day 0

    the total dosage of propofol used from induction till the end of the clinical treatment

  4. patients' discomfort

    Time frame: up to 24 hours

    any adverse reaction or discomfort complaints of patients will be recorded, such as sneeze, blocked nose, bitter taste, dizziness, rhinalgia, etc.

  5. hypoxemia

    Time frame: Day 0

    decreased oxygen saturation up to 90%, and the treatment will also be recorded(if any)

  6. peri-operative blood pressure

    Time frame: Day 0

    peri-operative blood pressure states

  7. peri-operative heart rate

    Time frame: Day 0

    peri-operative heart rate

  8. times of intra-operative airway assistance

    Time frame: Day 0

    Any intra-operative airway assistance in need which aims to improve ventilation will be recorded, including jaw lifting, suction, mask ventilation and intubation. Specific type of assistance will also be recorded in detail.

  9. post-operative pain

    Time frame: Day 0

    pain assessment with modified children's hospital of eastern Ontario pain score(m-CHEOPS) from the end of dental procedure till discharge

  10. post-operative agitation

    Time frame: Day 0

    emergence agitation assessment with Pediatric Anesthesia Emergence Delirium scale(PAED) from the end of dental procedure till discharge

  11. discharge time

    Time frame: Day 0

    time from the end of dental procedure till discharge

Other outcomes

  1. peri-operative satisfaction

    Time frame: up to 24 hours

    satisfaction of surgeon and parents during the whole clinical treatment and follow-up, they will be asked to give a score from 1 to 10, 10 stands for completely satisfied and 1 stands for not satisfied at all

  2. post-operative condition of the child

    Time frame: up to 24 hours

    complications and behavior changes assessed with Post-Hospitalization Behavior Questionnaire(PHBQ)

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

Intranasal Dexmedetomidine Versus Midazolam for Premedication in Deep-sedated Pediatric Dental Patients: a Double-blinded, Prospective, Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2020
Registry last updated
Feb 10, 2023

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.

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