Sedation, ConsciousPhase 4NCT02314546

Intranasal Midazolam in Children as a Pre-Operative Sedative

A Phase 4 study testing Midazolam and xylocaine in people with Sedation, Conscious, run by Bassett Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative. Read more about this study

Who is it for?: Ages 18 months to 7 years
Conditions the study is for: Sedation, Conscious
What is being tested?: Midazolam and xylocaine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Dec 2011to Jan 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 months to 7 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children aged 18 months-7 years, scheduled for a minor otolaryngology (ENT) surgical procedure requiring mask anesthesia
American Society of Anesthesiologists (ASA) Class 1 or 2
Parent willing and able to provide written informed consent
Parent willing and able to complete the OBD VAS

Who cannot join

ASA Class 3 or greater
History of allergy to midazolam or xylocaine
Presence of acute respiratory infection at time of surgery
Parent unwilling or unable to provide informed consent
Parent unwilling or unable to complete the OBD VAS

Trial locations and contacts

1 site in 1 country.

United States1 site

Bassett Healthcare Network
Cooperstown, New York, 13326

Other trials in United States

About this study

Read the detailed description

Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative.

Conditions: Sedation, Conscious
Being tested: Midazolam, xylocaine, saline placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MidazolamDrug
Also called versed
Study participants will be randomly assigned to one of three treatment groups:
- Group 1 - Placebo - Control patients will receive intranasal saline.
- Group 2 - Nasal Midazolam Only - Patients will receive 0.2 mg/kg of intranasal midazolam.
- Group 3 - Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
xylocaineDrug
Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
saline placeboDrug
Placebo - Control patients will receive intranasal saline.

Study groups in NCT02314546
Study group	Role	What they receive
Saline placebo	Placebo comparator	saline placebo Receives: Drug: saline placebo
Nasal Midazolam only	Active comparator	Nasal Midazolam only - Patients received 0.2 mg/kg of intranasal midazolam Receives: Drug: Midazolam
Midazolam and Xylocaine	Active comparator	Midazolam Plus Xylocaine - Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam Receives: Drug: Midazolam; Drug: xylocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Sedation Scale Score
Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.
Measured: 10 minutes post-sedation
Sedation Scale Score
Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.
Measured: 15 minutes post-sedation
Time From Administration to Discharge
Measured: Minutes from administration to discharge

Secondary outcomes (4)

Parental Observed Behavioral Distress Score
Measured by the accompanying parent using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).
Measured: 1 minute post-administration
RN Observed Behavioral Distress Score
Measured by the administering RN using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).
Measured: 1 minute post-administration
Verbal Complaint
Recorded by the administering RN at the time of administration.
Measured: At time of administration
Verbal Complaints
Recorded by the administering RN at one minute post-administration
Measured: 1 minute post-administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Jan 2014

First posted11 Dec 2014 (estimated)
Study startDec 2011
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sedation, ConsciousStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02314546
Sponsor's protocol ID: 994
Status last verified: Jun 2015
First submitted: 3 Dec 2014
Last updated: 23 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sedation, Conscious trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intranasal Midazolam in Children as a Pre-Operative Sedative
ClinicalTrials.gov ID: NCT02314546
Acronym / sponsor ID: 994
Conditions: Sedation, Conscious
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Bassett HealthcareUniversity, hospital or other
Study start: Dec 2011
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 11 Dec 2014 (estimated)
Results: Posted 23 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Saline placebo	Placebo comparator	Drug: saline placebosaline placebo
Nasal Midazolam only	Active comparator	Drug: MidazolamNasal Midazolam only - Patients received 0.2 mg/kg of intranasal midazolam
Midazolam and Xylocaine	Active comparator	Drug: Midazolam, Drug: xylocaineMidazolam Plus Xylocaine - Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam

Who may qualify

Ages: 18 months to 7 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Children aged 18 months-7 years, scheduled for a minor otolaryngology (ENT) surgical procedure requiring mask anesthesia
American Society of Anesthesiologists (ASA) Class 1 or 2
Parent willing and able to provide written informed consent
Parent willing and able to complete the OBD VAS

Key exclusion criteria (5 listed)

ASA Class 3 or greater
History of allergy to midazolam or xylocaine
Presence of acute respiratory infection at time of surgery
Parent unwilling or unable to provide informed consent
Parent unwilling or unable to complete the OBD VAS

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
MidazolamAlso: versedStudy participants will be randomly assigned to one of three treatment groups: * Group 1 - Placebo - Control patients will receive intranasal saline. * Group 2 - Nasal Midazolam Only - Patients will receive 0.2 mg/kg of intranasal midazolam. * Group 3 - Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.	Drug	Midazolam and Xylocaine, Nasal Midazolam only
xylocaineMidazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.	Drug	Midazolam and Xylocaine
saline placeboPlacebo - Control patients will receive intranasal saline.	Drug	Saline placebo

Primary outcome

Sedation Scale Score
Time frame: 10 minutes post-sedation
Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.
Sedation Scale Score
Time frame: 15 minutes post-sedation
Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.
Time From Administration to Discharge
Time frame: Minutes from administration to discharge

4 secondary outcomes

Parental Observed Behavioral Distress Score
Time frame: 1 minute post-administration
RN Observed Behavioral Distress Score
Time frame: 1 minute post-administration
Verbal Complaint
Time frame: At time of administration
Verbal Complaints
Time frame: 1 minute post-administration

Results and safety

Results posted to the registry on 23 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saline Placebo	5	5
Nasal Midazolam Only	5	5
Midazolam Plus Xylocaine	5	5

Primary outcome: Sedation Scale Score

Time frame: 10 minutes post-sedation. Number. Unit: participants

Measure	Saline Placebo n = 4	Nasal Midazolam Only n = 4	Midazolam Plus Xylocaine n = 5
Agitated	0	0	0
Alert	1	2	2
Calm	3	2	3
Drowsy	0	0	0
Asleep	0	0	0

Saline Placebo vs Nasal Midazolam Only vs Midazolam Plus Xylocaine: p = 0.99, Chi-squared

Population analysed: participants with available data at this time point

Primary outcome: Sedation Scale Score

Time frame: 15 minutes post-sedation. Number. Unit: participants

Measure	Saline Placebo n = 4	Nasal Midazolam Only n = 3	Midazolam Plus Xylocaine n = 3
Agitated	0	0	0
Alert	1	1	1
Calm	3	2	2
Drowsy	0	0	0
Asleep	0	0	0

Saline Placebo vs Nasal Midazolam Only vs Midazolam Plus Xylocaine: p = 0.99, Chi-squared

Population analysed: participants with available data at this time point

Primary outcome: Time From Administration to Discharge

Time frame: Minutes from administration to discharge. Mean (Standard Deviation). Unit: minutes

Measure	Saline Placebo n = 5	Nasal Midazolam Only n = 5	Midazolam Plus Xylocaine n = 5
Value	87.0 (21.9)	74.2 (9.6)	97.0 (18.9)

Saline Placebo vs Nasal Midazolam Only vs Midazolam Plus Xylocaine: p = 0.26, Kruskal-Wallis

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: During hospital stay.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Saline Placebo	0 of 5 (0%)	0 of 5 (0%)	Not reported
Nasal Midazolam Only	0 of 5 (0%)	0 of 5 (0%)	Not reported
Midazolam Plus Xylocaine	0 of 5 (0%)	0 of 5 (0%)	Not reported

Limitations and caveats (from the sponsor): Limitations in the number of providers and eligible patients during the two-year study period.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

david Ullman, MD principal investigator

Bassett Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Midazolam and xylocaine in people with Sedation, Conscious, run by Bassett Healthcare at 1 site in United States.

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 23 Jul 2015. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 23 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Sedation Scale Score (time frame: 10 minutes post-sedation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02314546.

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 23 Jul 2015.