Clinical trial NCT03399838: Comparing in Dexmedetomidine With po/pr Midazolam for Procedural Sedation in the Pediatric Emergency Department
Official title: The PedINDex Study: Comparing Intranasal Dexmedetomidine With Oral or Rectal Midazolam for Procedural Sedation in the Pediatric Emergency Department.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Procedural Anxiety
Emergencies
Keywords: Procedural Sedation and Analgesia
Pediatric Emergency Department
intranasal
dexmedetomidine
midazolam
anxiety relief
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised trial comparing 2 drugs (midazolam, dexmedetomidine)
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Efficacy of procedural sedation, using the 6 point Procedural Sedation State Scale PSSS
timeFrame: Initiation of procedure, around 30 minutes after medication was given
Secondary outcomes:
measure: Anxiety relief, measured with a validated 18-points-observer score
timeFrame: Baseline, positioning for procedure, initiation of procedure, end of procedure
Other outcomes:
Locations:
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Julia Hoeffe, MD
role: PRINCIPAL_INVESTIGATOR
References: