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Intranasal Midazolam in Children as a Pre-Operative Sedative

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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

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.

Condition or disease Intervention/treatment Phase
Sedation, Conscious Drug: Midazolam Drug: xylocaine Drug: saline placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Midazolam in Children as a Pre-Operative Sedative
Study Start Date : December 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Saline placebo
saline placebo
Drug: saline placebo
Placebo - Control patients will receive intranasal saline.

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

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
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.




Primary Outcome Measures :
  1. Sedation Scale Score [ Time Frame: 10 minutes post-sedation ]
    Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.

  2. Sedation Scale Score [ Time Frame: 15 minutes post-sedation ]
    Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.

  3. Time From Administration to Discharge [ Time Frame: Minutes from administration to discharge ]

Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Verbal Complaint [ Time Frame: At time of administration ]
    Recorded by the administering RN at the time of administration.

  4. Verbal Complaints [ Time Frame: 1 minute post-administration ]
    Recorded by the administering RN at one minute post-administration



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Ages Eligible for Study:   18 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314546


Locations
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United States, New York
Bassett Healthcare Network
Cooperstown, New York, United States, 13326
Sponsors and Collaborators
Bassett Healthcare
Investigators
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Principal Investigator: david Ullman, MD Bassett Healthcare

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Responsible Party: David A Ullman MD, Attending Physician - Anesthesiology, Bassett Healthcare
ClinicalTrials.gov Identifier: NCT02314546     History of Changes
Other Study ID Numbers: 994
First Posted: December 11, 2014    Key Record Dates
Results First Posted: July 23, 2015
Last Update Posted: July 23, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Lidocaine
Midazolam
Hypnotics and Sedatives
Adjuvants, Anesthesia
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators