NCT02314546

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 23, 2015

Completed
Last Updated

July 23, 2015

Status Verified

June 1, 2015

Enrollment Period

2.1 years

First QC Date

December 3, 2014

Results QC Date

January 28, 2015

Last Update Submit

June 25, 2015

Conditions

Sedation, Conscious

Outcome Measures

Primary Outcomes (3)

  • Sedation Scale Score

    Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.

    10 minutes post-sedation

  • Sedation Scale Score

    Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.

    15 minutes post-sedation

  • Time From Administration to Discharge

    Minutes from administration to discharge

Secondary Outcomes (4)

  • Parental Observed Behavioral Distress Score

    1 minute post-administration

  • RN Observed Behavioral Distress Score

    1 minute post-administration

  • Verbal Complaint

    At time of administration

  • Verbal Complaints

    1 minute post-administration

Study Arms (3)

Saline placebo

PLACEBO COMPARATOR

saline placebo

Drug: saline placebo

Nasal Midazolam only

ACTIVE COMPARATOR

Nasal Midazolam only - Patients received 0.2 mg/kg of intranasal midazolam

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

Drug: MidazolamDrug: xylocaine

Interventions

MidazolamDRUG

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.

Also known as: versed
Midazolam and XylocaineNasal Midazolam only
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.

Midazolam and Xylocaine
saline placeboDRUG

Placebo - Control patients will receive intranasal saline.

Saline placebo

Eligibility Criteria

Age18 Months - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

MeSH Terms

Interventions

MidazolamLidocaine

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and Caveats

Limitations in the number of providers and eligible patients during the two-year study period.

Results Point of Contact

Title
David A. Ullman, MD, Senior Attending Anesthesiologist
Organization
Bassett Healthcare Network
david.ullman@bassett.org
607-547-3153

Study Officials

  • david Ullman, MD

    Bassett Healthcare

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician - Anesthesiology

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 11, 2014

Study Start

December 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 23, 2015

Results First Posted

July 23, 2015

Record last verified: 2015-06

Locations

US(1)