Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients

• Sponsor: Peking University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04509414
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 28.7
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Deep Sedation; Dexmedetomidine	Drug: Dexmedetomidine; Drug: Midazolam	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Intranasal Dexmedetomidine Versus Midazolam for Premedication in Deep-sedated Pediatric Dental Patients: a Double-blinded, Prospective, Randomized Controlled Trial
• Actual Study Start Date: Aug 10, 2020
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dexmedetomidine 2ug/kg intranasal atomized dexmedetomidine	Drug: Dexmedetomidine; For dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated.
Active Comparator: midazolam 0.2mg/kg intranasal atomized midazolam	Drug: Midazolam; For midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated.

Outcome Measures

Primary Outcome Measures

1. venipuncture acceptance [Day 0]

   acceptance while starting the IV line, at most 2 tries

Secondary Outcome Measures

1. Observer's Assessment of Alertness/Sedation(MOAA/S) Score [Day 0]

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

2. remedial mask induction acceptance [Day 0]

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

3. propofol dosage [Day 0]

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

4. patients' discomfort [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 [Day 0]

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

6. peri-operative blood pressure [Day 0]

   peri-operative blood pressure states

7. peri-operative heart rate [Day 0]

   peri-operative heart rate

8. times of intra-operative airway assistance [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 [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 [Day 0]

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

11. discharge time [Day 0]

    time from the end of dental procedure till discharge

Other Outcome Measures

1. peri-operative satisfaction [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 [up to 24 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 7 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. children in need of deep sedation for dental treatment aged 3-7 years.

2. anticipated operation time 1-2hours

Exclusion Criteria:

1. any known medical records with neural or mental disorder

2. any known medical records with severe systemic disorder

3. history of sedation drug administration in recent 1 months

4. any known allergic history of dexmedetomidine, midazolam or propofol

5. morbid obesity

6. history of OSAHS or acute respiratory infection in 2 weeks

7. other conditions which the attending considers to be unfit for the trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Hospital of Stomatology	Beijing	Beijing	China	100081

Sponsors and Collaborators

• Peking University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yang Xudong, Chief of Department of Anesthesiology, Peking University
• ClinicalTrials.gov Identifier: NCT04509414
• Other Study ID Numbers: PKUSSIRB-202056077
• First Posted: Aug 12, 2020
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Yang Xudong, Chief of Department of Anesthesiology, Peking University: deep sedation; pediatric; dexmedetomidine; dental treatment
• Additional relevant MeSH terms: Midazolam; Dexmedetomidine

Study Results

No Results Posted as of Mar 15, 2022