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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03399838
Recruitment Status : Not yet recruiting
First Posted : January 16, 2018
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment Phase
Procedural Anxiety Emergencies Drug: Dexmedetomidine Drug: Midazolam Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomised trial comparing 2 drugs (midazolam, dexmedetomidine)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The PedINDex Study: Comparing Intranasal Dexmedetomidine With Oral or Rectal Midazolam for Procedural Sedation in the Pediatric Emergency Department.
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  1. Efficacy of procedural sedation, using the 6 point Procedural Sedation State Scale PSSS [ Time Frame: Initiation of procedure, around 30 minutes after medication was given ]
    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.


Secondary Outcome Measures :
  1. Anxiety relief, measured with a validated 18-points-observer score [ Time Frame: Baseline, positioning for procedure, initiation of procedure, end of procedure ]
    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.



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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399838


Contacts
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Contact: Julia Hoeffe, MD 0316328707 julia.hoeffe@insel.ch
Contact: Fabrizio Romano, MD 0041316325468 fabrizio.romano@insel.ch

Locations
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Switzerland
Pediatric Emergency Department, Inselspital
Bern, Switzerland, 3010
Contact: Fabrizio Romano    0041316325468    fabrizio.romano@insel.ch   
Contact: Roland Ammann    0316321087    roland.ammann@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Julia Hoeffe, MD University Hospital Inselspital, Berne
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03399838    
Other Study ID Numbers: PedINDEX study
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 University Hospital Inselspital, Berne:
Procedural Sedation and Analgesia
Pediatric Emergency Department
intranasal
dexmedetomidine
midazolam
anxiety relief
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents