Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intranasal Midazolam in Children as a Pre-Operative Sedative

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02314546
Recruitment Status : Completed
First Posted : December 11, 2014
Results First Posted : July 23, 2015
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
David A Ullman MD, Bassett Healthcare

Tracking Information
First Submitted Date  ICMJE December 3, 2014
First Posted Date  ICMJE December 11, 2014
Results First Submitted Date  ICMJE January 28, 2015
Results First Posted Date  ICMJE July 23, 2015
Last Update Posted Date July 23, 2015
Study Start Date  ICMJE December 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
Sedation scale scores [ Time Frame: approximately 20- 25 minutes ]
The Certified Registered Nurse Anesthetist (CRNA) or the anesthesiologist (MDA) will complete the sedation scale at time of induction of anesthesia.
Change History Complete list of historical versions of study NCT02314546 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
  • Parental Observed Behavioral Distress Score [ Time Frame: 1 minute post-administration ]
    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).
  • RN Observed Behavioral Distress Score [ Time Frame: 1 minute post-administration ]
    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).
  • Verbal Complaint [ Time Frame: At time of administration ]
    Recorded by the administering RN at the time of administration.
  • Verbal Complaints [ Time Frame: 1 minute post-administration ]
    Recorded by the administering RN at one minute post-administration
Original Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2014)
  • Observed Behavioral Distress Scores (OBD) [ Time Frame: 1 minute & 5 minutes post administration ]
    The administering Registered Nurse (RN) and 1 accompanying parent will complete the Observed Behavioral Distress (OBD) VAS at 1 minute and 5 minutes post administration
  • Number of episodes of epistaxis [ Time Frame: from administration to discharge home, which should be approximately 3 hours total ]
  • Time to discharge [ Time Frame: from transfer to post anesthesia care unit (PACU) to discharge home, which should be approximately 1-2 hours ]
    The time to discharge from the Post Anesthesia Care Unite (PACU) to the Ambulatory Surgery Unit (ASU) and then from ASU to home will be recorded.
  • Sedation scale [ Time Frame: 10 minutes ]
    The administering RN will complete the Sedation scale at 10 minutes after study drug administration
  • Sedation scale [ Time Frame: 15 minutes ]
    The administering RN will complete the Sedation scale at 15 minutes after study drug administration
  • Sedation scale [ Time Frame: approximately 15-20 minutes ]
    The CRNA/MDA will complete the sedation scale at the time of transport to the OR
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Midazolam in Children as a Pre-Operative Sedative
Official Title  ICMJE Intranasal Midazolam in Children as a Pre-Operative Sedative
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sedation, Conscious
Intervention  ICMJE
  • Drug: Midazolam

    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.
    Other Name: versed
  • Drug: xylocaine
    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: saline placebo
    Placebo - Control patients will receive intranasal saline.
Study Arms  ICMJE
  • Placebo Comparator: Saline placebo
    saline placebo
    Intervention: Drug: saline placebo
  • Active Comparator: Nasal Midazolam only
    Nasal Midazolam only - Patients received 0.2 mg/kg of intranasal midazolam
    Intervention: Drug: Midazolam
  • Active Comparator: Midazolam and Xylocaine
    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
    Interventions:
    • Drug: Midazolam
    • Drug: xylocaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2014)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Children aged 18 months-7 years, scheduled for a minor otolaryngology (ENT) 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 OBD 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02314546
Other Study ID Numbers  ICMJE 994
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David A Ullman MD, Bassett Healthcare
Study Sponsor  ICMJE Bassett Healthcare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: david Ullman, MD Bassett Healthcare
PRS Account Bassett Healthcare
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP