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NCT Number: NCT02356705

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

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

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Key information

Conditions

Sedation

Age range

18 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 18 months-7 years, scheduled for a minor Ear/Nose/Throat 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 Observed Behavioral Distress (OBD) Visual Assessment Scale (VAS)

Exclusion criteria

  • 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

Treatment and study plan

midazolam

Drug

midazolam 0.2 mg/kg given intranasally

Xylocaine

Drug

intransal xylocaine given in conjunction with intranasal midazolam

Saline placebo

Drug

intranasal saline given as placebo

Primary outcomes

  1. Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement

    Time frame: 25 minutes

    Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement

    • 1. Agitated: Previous criteria and/or refuses mask. (worst score)
    • 2. Alert: Previous criteria and/or initially refuses mask, but accept after persuasion.
    • 3. Calm: Previous criteria and accepts mask.
    • 4. Drowsy: Previous criteria and accepts mask.
    • 5. Asleep: Previous criteria and accepts mask. (best score)

Secondary outcomes

  1. Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room

    Time frame: 20 minutes

    Pediatric Pre-Induction Anesthesia Scale - scored by the anesthesiologist or the CRNA upon arrival to the operating room, prior to induction of anesthesia

    • 1. Agitated: Patient clinging to parents and/or crying (worst score)
    • 2. Alert: Patient is aware but not clinging to parent, may whimper but not cry.
    • 3. Calm: Sitting or lying comfortably with spontaneous eye opening.
    • 4. Drowsy: Sitting or lying comfortably with eyes closed, but responding to minor stimulation.
    • 5. Asleep: Eyes closed, arousable but does not respond to minor stimulation. (best score)

Other outcomes

  1. Time to Discharge

    Time frame: approximately 3 hours

    The time (in minutes) from release from the operating room to discharge home

  2. Number of Participants With Nosebleeds From Time of Drug Administration to Discharge Home

    Time frame: approximately 3 hours

    Number of participants with nosebleeds recorded in the pre-operative, intra-operative and post-operative record after study drug administration.

  3. Observational Distress Score at 1 Minute (Blinded Study Nurse Assessment)

    Time frame: 1 minute

    Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress). Recorded by the blinded study nurse.

  4. Observational Distress Score 5 Min (Blinded Study Nurse Assessmnet)

    Time frame: 5minutes

    Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress) as measured by the blinded study nurse.

Sponsors and collaborators

Lead sponsor

Jennifer Victory, RN, CCRC

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2015
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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