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

The PedINDex Study: Comparing Intranasal Dexmedetomidine With Oral or Rectal Midazolam for Procedural Sedation in the Pediatric Emergency Department.

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.

Study Overview

• Status: Withdrawn
• Conditions: Emergencies; Procedural Anxiety
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Midazolam

Detailed Description

Pediatric sedation and analgesia is a major aspect in emergency procedures and treatments: anxiety and stress in children need to be purposefully addressed in order to perform procedures where a child needs to lie still, and to prevent anxiety in the future. An important factor to reduce stress and anxiety is the use of medication without the need of an intravenous access. To date, options for such a sedation are very limited. One of the most common medications in use is midazolam applied orally or rectally, though there are several concerns with this drug.

Pediatric developmental stage often does not allow to rationally explain procedures (e.g., wound management, emergency radiologic imaging, lumbar punctures, posing a difficult iv line), thus provoking further anxiety and non-compliance.

The medication in question (dexmedetomidine, DEX) has been proven to be a safe and reliable sedative in different settings even though its use is off-label in pediatrics. Data on its use in the pediatric emergency department (PED) are sparse, but it could be of help in a variety of situations especially in this setting.

The overall objective of this study is to determine whether intranasal (IN) DEX has better efficacy profile for PSA in the PED compared to rectal (PR)/ oral (PO) midazolam in children aged 6 months to 6 years.

Validated scores are used to describe efficacy in detail, including Procedural Sedation State Scale, Modified Yale Preoperative Anxiety Scale Short Form, University of Michigan Sedation State. Surveys to the parents and the health care professionals are used to further describe efficacy.

Procedural Sedation State Scale will be the primary outcome. Based on clinical experience we expect around 70% of patients with midazolam sedation to score 2 or 3 using the PSSS (target sedation state). Clinically relevant superiority is defined as 15% more patients with target sedation state.

Study design: single-center, prospective, randomised, active control, rater-blinded trial: procedures will be videotaped and analysed by research assistants blinded to the study medication.

Number of patients: 210 with assessable primary outcome. Duration of recruitment is expected to be 24 months

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dexmedetomidine; Application of single dose of 4mcg/kg dexmedetomidine intranasally for pediatric procedural sedation at the emergency department	Drug: Dexmedetomidine; IN Dex for pediatric procedural sedation at the emergency department
ACTIVE_COMPARATOR: Midazolam; 0.5mg po/pr midazolam for pediatric sedation at the emergency department	Drug: Midazolam; po/pr midazolam as active comparator to dexmedetomidine for pediatric procedural sedation at the pediatric emergency department

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety relief, measured with a validated 18-points-observer score	mYPAS-SF (Modified Yale Preoperative Anxiety Scale Short Form) is a validated anxiety scale in pediatric sedation. Scores range from 4 to 18, with 18 being the highest level of anxiety. Lower scores are a better outcome.	Baseline, positioning for procedure, initiation of procedure, end of procedure

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Julia Hoeffe, MD, University Hospital Inselspital, Berne

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2023
• Primary Completion (ANTICIPATED): July 31, 2024
• Study Completion (ANTICIPATED): August 31, 2024

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (ACTUAL): January 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: midazolam; intranasal; dexmedetomidine; Procedural Sedation and Analgesia; anxiety relief; Pediatric Emergency Department
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: PedINDEX study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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