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Enrolling by Invitation

NCT Number: NCT04669457

Pediatric Delirium

Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.

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Key information

Conditions

Pediatric Delirium

Age range

3 month–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

About this study

Pediatric ambulatory patients will randomly be allocated to one of two groups. Group A which will receive Dexmedetomidine intra-nasally at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room or Group B which will receive Midazolam orally at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. Each subject will receive a Drug Acceptance scale, and Parental Separation Anxiety Scale (PSAS) mask Acceptance Scale to identify the differences in markers associated with pediatric delirium. End tidal Sevoflurane value during the surgery and at the time when patient leaves the OR, amount and dose of oral/rectal acetaminophen given in PACU, child's behavior for 48 hours post-operatively, and documented intake of oral analgesics will be collected to identify the reduced need for post-operative analgesia and behaviors associated with extended pediatric delirium.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects age 3 months to 9 years
  • Scheduled to undergo a myringotomy
  • American Society of Anesthesiologists (ASA) classification of I - II.

Exclusion criteria

  • Subjects with unrepaired cardiac defects, including cyanotic congenital heart disease.
  • Anyone age 10 years or older.
  • Anyone with an ASA classification of III or higher.
  • Non-English language speaker for whom short form consent is not available.

Treatment and study plan

Intra-nasal Dexmedetomidine

Drug

Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room.

Other names: Precedex

oral midazolam

Drug

Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room.

Other names: Midazolam

Primary outcomes

  1. Time to onset of pediatric delirium

    Time frame: Zero minutes to 48 hours

    Time from when the patient is woken from anesthesia to the onset of delirium.

  2. Time to offset of pediatric delirium

    Time frame: Zero minutes to 48 hours

    Time from onset of delirium to the offset of delirium.

  3. Duration of pediatric delirium

    Time frame: Zero minutes to 48 hours

    Total time patient experiences delirium

Secondary outcomes

  1. Drug Acceptance

    Time frame: 10-25 minutes prior to surgery

    The willingness of the subject to take the drug was assessed in the pre-operative area

  2. Parental Separation Anxiety Scale (PSAS)

    Time frame: 0-48 hours

    Anxiety score was determined when the child was separated from the parents according to four levels.

  3. Mask Acceptance Scale

    Time frame: 1-10 minutes prior to surgery

    The child's acceptance of the mask by the anesthesiologist was rated as follows.

  4. End tidal Sevoflurane value

    Time frame: 0-12 hours

    During the surgery and at the time when patient leaves the OR End tidal Sevoflurane value will be documented.

  5. Rescue analgesia in PACU

    Time frame: 0-6 hours post surgery

    The amount and dose of oral/rectal acetaminophen given in PACU was recorded.

  6. Home Behavior Analysis

    Time frame: 12-48 hours

    The child's parents were given a diary to document their behavior for 48 hours post-operatively at home.

  7. Oral analgesic use

    Time frame: Two days post-operative

    Document intake of oral analgesics like acetaminophen or ibuprofen

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

Prevention of Emergence Delirium in Pediatric Ambulatory Surgery: Single Blinded Randomized Control Study Comparing Intra-nasal Dexmedetomidine With Oral Midazolam.

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2020
Registry last updated
Jul 15, 2026

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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