Skip to main content
OpenTrials
Completed

NCT Number: NCT02314546

Intranasal Midazolam in Children as a Pre-Operative Sedative

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sedation, Conscious

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

About this study

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.

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 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

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

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 names: versed

Xylocaine

Drug

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.

Saline placebo

Drug

Placebo - Control patients will receive intranasal saline.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bassett Healthcare

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2014
Registry last updated
Jul 23, 2015

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.