Procedural SedationNCT03635398
Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study
A study testing Sipnose device, MAD (Mucosal Atomization Device) and midazolam in people with Procedural Sedation and Intra-nasal Delevery Device, run by Rabin Medical Center at 1 site in Israel.
Trial summary
A Three-arm, Randomized Controlled Trial for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety: Intranasal Midazolam by SipNose versus MAD Versus oral administration Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Procedural Sedation, Intra-nasal Delevery Device
- What is being tested?
- Sipnose device, MAD (Mucosal Atomization Device) and midazolam
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2018to Jul 2020
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- every child >1y who is intended for medical procedure in the emrgency room(suce as: IV insertion, blood sample collection, urinary catether insertion, laceration repair
Who cannot join
- ASA>2
- Active respiratory infection
- systemic illness
- Allergy to Midazolam
Trial locations and contacts
1 site in 1 country.
About this study
A Three-arm, Randomized Controlled Trial for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety: Intranasal Midazolam by SipNose versus MAD Versus oral administration
- Conditions
- Procedural Sedation, Intra-nasal Delevery Device
- Being tested
- Sipnose device, MAD (Mucosal Atomization Device), midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sipnose deviceDevice
SipNose's intranasal drug delivery platform uses an innovative mechanism that is suposed to improves efficacy, patient compliance and safety
MAD (Mucosal Atomization Device)Device
MAD (Mucosal Atomization Device)
midazolamDrug
oral administration of midazolam
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Midazolam by SipNose device | Experimental | Not described Receives: Device: Sipnose device |
| Intranasal Midazolam by MAD (Mucosal Atomization Device) | Active comparator | Not described Receives: Device: MAD (Mucosal Atomization Device) |
| oral administration of midazolam | Active comparator | Not described Receives: Drug: midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anexiety level
measured by modified PREOPERATIVE ANXIETY SCALE (YALE)
Measured: within 60 minute
Sedation level
measured by RAMSAY SEDATION SCALE
Measured: within 60 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study startAug 2018 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- SipNose
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635398
- Sponsor's protocol ID
- RMC-17-0435
- Status last verified
- Aug 2018
- First submitted
- 15 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because of commercial confidentially the study database will not become public within the first 3 years since the begining of the study
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03635398
- Acronym / sponsor ID
- RMC-17-0435
- Conditions
- Procedural Sedation, Intra-nasal Delevery Device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- SipNose
- Study start
- Aug 2018 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 17 Aug 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.
A Three-arm, Randomized Controlled Trial for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety: Intranasal Midazolam by SipNose versus MAD Versus oral administration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intranasal Midazolam by SipNose device | Experimental | Device: Sipnose device |
| Intranasal Midazolam by MAD (Mucosal Atomization Device) | Active comparator | Device: MAD (Mucosal Atomization Device) |
| oral administration of midazolam | Active comparator | Drug: midazolam |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- every child >1y who is intended for medical procedure in the emrgency room(suce as: IV insertion, blood sample collection, urinary catether insertion, laceration repair
Key exclusion criteria (4 listed)
- ASA>2
- Active respiratory infection
- systemic illness
- Allergy to Midazolam
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 |
|---|---|---|
| Sipnose deviceSipNose's intranasal drug delivery platform uses an innovative mechanism that is suposed to improves efficacy, patient compliance and safety | Device | Intranasal Midazolam by SipNose device |
| MAD (Mucosal Atomization Device)MAD (Mucosal Atomization Device) | Device | Intranasal Midazolam by MAD (Mucosal Atomization Device) |
| midazolamoral administration of midazolam | Drug | oral administration of midazolam |
Primary outcome
Anexiety level
Time frame: within 60 minute
measured by modified PREOPERATIVE ANXIETY SCALE (YALE)
Sedation level
Time frame: within 60 minute
measured by RAMSAY SEDATION SCALE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Individual participant dataSharing planned: No. Because of commercial confidentially the study database will not become public within the first 3 years since the begining of the study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sipnose device, MAD (Mucosal Atomization Device) and midazolam in people with Procedural Sedation and Intra-nasal Delevery Device, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
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?
Anexiety level (time frame: within 60 minute). The study lists 2 primary outcomes in all. 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 17 Aug 2018.