Intranasal Midazolam in Children as a Pre-Operative Sedative

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2014

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Placebo Comparator: Saline placebo
    • saline placebo
  • Active Comparator: Nasal Midazolam only
    • Nasal Midazolam only – Patients received 0.2 mg/kg of intranasal 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Months

Maximum Age: 7 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bassett Healthcare
  • Provider of Information About this Clinical Study
    • Principal Investigator: David A Ullman MD, Attending Physician – Anesthesiology – Bassett Healthcare
  • Overall Official(s)
    • david Ullman, MD, Principal Investigator, Bassett Healthcare

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