SedationPhase 4NCT02356705
Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
A Phase 4 study testing Midazolam and xylocaine in people with Sedation, run by Jennifer Victory, RN, CCRC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 months to 7 years
- Conditions the study is for
- Sedation
- What is being tested?
- Midazolam and xylocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2017
- 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 Ear/Nose/Throat 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 Observed Behavioral Distress (OBD) Visual Assessment Scale (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
About this study
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. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
midazolam 0.2 mg/kg given intranasally
xylocaineDrug
intransal xylocaine given in conjunction with intranasal midazolam
saline placeboDrug
intranasal saline given as placebo
| Study group | Role | What they receive |
|---|---|---|
| Saline Placebo | Placebo comparator | Control patients will receive intranasal saline Receives: Drug: saline placebo |
| Nasal Midazolam Only | Active comparator | Patients will receive 0.2 mg/kg of intranasal midazolam Receives: Drug: Midazolam |
| Midazolam Plus Xylocaine | Active comparator | Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% 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.
Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement
Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement
- 1. Agitated: Previous criteria and/or refuses mask. (worst score)
- 2. Alert: Previous criteria and/or initially refuses mask, but accept after persuasion.
- 3. Calm: Previous criteria and accepts mask.
- 4. Drowsy: Previous criteria and accepts mask.
- 5. Asleep: Previous criteria and accepts mask. (best score)
Measured: 25 minutes
Secondary outcomes (1)
Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room
Pediatric Pre-Induction Anesthesia Scale - scored by the anesthesiologist or the CRNA upon arrival to the operating room, prior to induction of anesthesia
- 1. Agitated: Patient clinging to parents and/or crying (worst score)
- 2. Alert: Patient is aware but not clinging to parent, may whimper but not cry.
- 3. Calm: Sitting or lying comfortably with spontaneous eye opening.
- 4. Drowsy: Sitting or lying comfortably with eyes closed, but responding to minor stimulation.
- 5. Asleep: Eyes closed, arousable but does not respond to minor stimulation. (best score)
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017
- Study completionDec 2017
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Victory, RN, CCRC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Victory, RN, CCRC, Bassett Healthcare
- Investigators
- david Ullman, MD, Principal investigator, Bassett Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356705
- Sponsor's protocol ID
- 1098
- Status last verified
- Mar 2022
- First submitted
- 2 Feb 2015
- Last updated
- 16 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2
- ClinicalTrials.gov ID
- NCT02356705
- Acronym / sponsor ID
- 1098
- Conditions
- Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Jennifer Victory, RN, CCRCUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Feb 2015 (estimated)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration
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 placeboControl patients will receive intranasal saline |
| Nasal Midazolam Only | Active comparator | Drug: MidazolamPatients will receive 0.2 mg/kg of intranasal midazolam |
| Midazolam Plus Xylocaine | Active comparator | Drug: Midazolam, Drug: xylocainePatients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% 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 Ear/Nose/Throat 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 Observed Behavioral Distress (OBD) Visual Assessment Scale (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 |
|---|---|---|
| Midazolammidazolam 0.2 mg/kg given intranasally | Drug | Midazolam Plus Xylocaine, Nasal Midazolam Only |
| xylocaineintransal xylocaine given in conjunction with intranasal midazolam | Drug | Midazolam Plus Xylocaine |
| saline placebointranasal saline given as placebo | Drug | Saline Placebo |
Primary outcome
Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement
Time frame: 25 minutes
Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement * 1. Agitated: Previous criteria and/or refuses mask. (worst score) * 2. Alert: Previous criteria and/or initially refuses mask, but accept after persuasion. * 3. Calm: Previous criteria and accepts mask. * 4. Drowsy: Previous criteria and accepts mask. * 5. Asleep: Previous criteria and accepts mask. (best score)
1 secondary outcome
Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room
Time frame: 20 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- 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, run by Jennifer Victory, RN, CCRC 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 16 Mar 2022. 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 25 Feb 2021). 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?
Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement (time frame: 25 minutes). 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 16 Mar 2022.