Comparing in Dexmedetomidine With po/pr Midazolam for Procedural Sedation in the Pediatric Emergency Department

NCT03399838 | Withdrawn Phase 4 DMC

• 1 other identifier: PedINDEX study
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare efficacy of Procedural Sedation with Dexmedetomidine as compared to Midazolam in the pediatric Emergency Department. 210 children aged 6 months to 6 years will be included and randomly assigned to receiving oral or rectal midazolam (standard of care) or intranasal dexmedetomidine for procedures at the emergency department where mainly a sedation and no analgesia is sought. The procedure will be videotaped and analysis is blinded to the medication.

Conditions

Procedural Anxiety; Emergencies

Keywords

Procedural Sedation and Analgesia; Pediatric Emergency Department; intranasal; dexmedetomidine; midazolam; anxiety relief

Outcome Measures

Primary Outcomes (1)

• Efficacy of procedural sedation, using the 6 point Procedural Sedation State Scale PSSS

  Primary outcome is target sedation state measured with the PSSS (Pediatric Sedation State Scale) at initiation of the procedure, assessed via videotape by two independent research assistants. This scale has been developed and validated to reflect behaviours associated with adequate and inadequate sedation, in addition to adverse events associated with excessive sedation. States are predefined and related to the numbers 0 to 5. State 2 and 3 are defined as target sedation state. Primary outcome are number of patients in target sedation state.

  Initiation of procedure, around 30 minutes after medication was given

Secondary Outcomes (1)

• Anxiety relief, measured with a validated 18-points-observer score

  Baseline, positioning for procedure, initiation of procedure, end of procedure

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Application of single dose of 4mcg/kg dexmedetomidine intranasally for pediatric procedural sedation at the emergency department

Drug: Dexmedetomidine

Midazolam

ACTIVE COMPARATOR

0.5mg po/pr midazolam for pediatric sedation at the emergency department

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

IN Dex for pediatric procedural sedation at the emergency department

Dexmedetomidine

Midazolam DRUG

po/pr midazolam as active comparator to dexmedetomidine for pediatric procedural sedation at the pediatric emergency department

Midazolam

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 6 months and 6 years presenting at the pediatric emergency department
• Indication for midazolam as sedation
• Signed informed consent

You may not qualify if:

• Contraindication for midazolam
• Contraindication for dexmedetomidine
• Contraindication for moderate sedation in general

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

MeSH Terms

Conditions

Emergencies; Agnosia

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Julia Hoeffe, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomised trial comparing 2 drugs (midazolam, dexmedetomidine)

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: August 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share