Procedural AnxietyPhase 4PedINDEXNCT03399838
Comparing in Dexmedetomidine With po/pr Midazolam for Procedural Sedation in the Pediatric Emergency Department
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Procedural Anxiety and Emergencies, run by Insel Gruppe AG, University Hospital Bern.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Procedural Anxiety, Emergencies
- What is being tested?
- Dexmedetomidine and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to 31 Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 6 months and 6 years presenting at the pediatric emergency department
- Indication for midazolam as sedation
- Signed informed consent
Who cannot join
- Contraindication for midazolam
- Contraindication for dexmedetomidine
- Contraindication for moderate sedation in general
About this study
Official title: 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.
Read the 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
- Being tested
- Dexmedetomidine, Midazolam
- Keywords
- Procedural Sedation and Analgesia, Pediatric Emergency Department, intranasal, dexmedetomidine, midazolam, anxiety relief
- Medical subject headings
- Emergencies, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
IN Dex for pediatric procedural sedation at the emergency department
MidazolamDrug
po/pr midazolam as active comparator to dexmedetomidine for pediatric procedural sedation at the pediatric emergency department
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Application of single dose of 4mcg/kg dexmedetomidine intranasally for pediatric procedural sedation at the emergency department Receives: Drug: Dexmedetomidine |
| Midazolam | Active comparator | 0.5mg po/pr midazolam for pediatric sedation at the emergency department Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Initiation of procedure, around 30 minutes after medication was given
Secondary outcomes (1)
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.
Measured: Baseline, positioning for procedure, initiation of procedure, end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study startAug 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Why it stopped: Sponsor left the hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural AnxietyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised trial comparing 2 drugs (midazolam, dexmedetomidine)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Hoeffe, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399838
- Sponsor's protocol ID
- PedINDEX study
- Acronym
- PedINDEX
- Status last verified
- Sep 2022
- First submitted
- 8 Jan 2018
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PedINDex Study: Comparing Intranasal Dexmedetomidine With Oral or Rectal Midazolam for Procedural Sedation in the Pediatric Emergency Department.
- ClinicalTrials.gov ID
- NCT03399838
- Acronym / sponsor ID
- PedINDEX / PedINDEX study
- Conditions
- Procedural Anxiety, Emergencies
- Keywords
- Procedural Sedation and Analgesia, Pediatric Emergency Department, intranasal, dexmedetomidine, midazolam, anxiety relief
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor left the hospital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised trial comparing 2 drugs (midazolam, dexmedetomidine)
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineApplication of single dose of 4mcg/kg dexmedetomidine intranasally for pediatric procedural sedation at the emergency department |
| Midazolam | Active comparator | Drug: Midazolam0.5mg po/pr midazolam for pediatric sedation at the emergency department |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged between 6 months and 6 years presenting at the pediatric emergency department
- Indication for midazolam as sedation
- Signed informed consent
Key exclusion criteria (3 listed)
- Contraindication for midazolam
- Contraindication for dexmedetomidine
- Contraindication for moderate sedation in general
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineIN Dex for pediatric procedural sedation at the emergency department | Drug | Dexmedetomidine |
| Midazolampo/pr midazolam as active comparator to dexmedetomidine for pediatric procedural sedation at the pediatric emergency department | Drug | Midazolam |
Primary outcome
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.
1 secondary outcome
Anxiety relief, measured with a validated 18-points-observer score
Time frame: Baseline, positioning for procedure, initiation of procedure, end of procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Hoeffe, MD principal investigator
Insel Gruppe AG, University Hospital Bern
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Midazolam in people with Procedural Anxiety and Emergencies, run by Insel Gruppe AG, University Hospital Bern.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.