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

NCT ID: NCT03399838

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-08-31

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.

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

Conditions

Procedural Anxiety; Emergencies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dexmedetomidine

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

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

IN Dex for pediatric procedural sedation at the emergency department

Midazolam

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

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

IN Dex for pediatric procedural sedation at the emergency department

Intervention Type: DRUG

Midazolam

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Hoeffe, MD

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Other Identifiers

PedINDEX study

Identifier Type: -

Identifier Source: org_study_id