Cooperstown, New York 13326


Purpose:

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


Criteria:

Inclusion Criteria: 1. Children aged 18 months-7 years, scheduled for a minor Ear/Nose/Throat surgical procedure requiring mask anesthesia 2. American Society of Anesthesiologists (ASA) Class 1 or 2 3. Parent willing and able to provide written informed consent 4. Parent willing and able to complete the Observed Behavioral Distress (OBD) Visual Assessment Scale (VAS) Exclusion Criteria: 1. ASA Class 3 or greater 2. History of allergy to midazolam or xylocaine 3. Presence of acute respiratory infection at time of surgery 4. Parent unwilling or unable to provide informed consent 5. Parent unwilling or unable to complete the OBD VAS


Study is Available At:


Original ID:

1098


NCT ID:

NCT02356705


Secondary ID:


Study Acronym:


Brief Title:

Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2


Official Title:

Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2


Overall Status:

Recruiting


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Months


Maximum Age:

7 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Bassett Healthcare


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

45


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:david Ullman, MD
Principal Investigator
Bassett Healthcare
Primary Contact:jennifer victory, RN
607-547-6965
jennifer.victory@bassett.org
Backup Contact:catherine gilmore, RN
607-547-7926
catherine.gilmore@bassett.org

Study Dates

Start Date:January 2015
Primary Completion Date:January 2017
Primary Completion Type:Anticipated
Verification Date:March 2016
Last Changed Date:March 24, 2016
First Received Date:February 2, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Pediatric Pre-Induction Anesthesia Scale at arrival to operating room
Time Frame:20 minutes
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pediatric Pre-Induction Anesthesia Scale at time of mask placement
Time Frame:25 minutes
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Midazolam
Description:midazolam 0.2 mg/kg given intranasally
Arm Name:Nasal Midazolam Only
Intervention Type:Drug
Name:xylocaine
Description:intransal xylocaine given in conjunction with intranasal midazolam
Arm Name:Midazolam Plus Xylocaine
Intervention Type:Drug
Name:saline placebo
Description:intranasal saline given as placebo
Arm Name:Saline Placebo

Study Arms

Study Arm Type:Active Comparator
Arm Name:Midazolam Plus Xylocaine
Description:Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam.
Study Arm Type:Active Comparator
Arm Name:Nasal Midazolam Only
Description:Patients will receive 0.2 mg/kg of intranasal midazolam
Study Arm Type:Placebo Comparator
Arm Name:Saline Placebo
Description:Control patients will receive intranasal saline

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Bassett Healthcare

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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