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RecruitingAccepts healthy volunteersPhase 4

IN Midazolam vs IN Dexmedetomidine vs IN Ketamine During Minimal Procedures in Pediatric ED

University of Oklahoma · NCT05934669

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 1–5 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
90
US sites recruiting
1
Study start
November 14, 2023
Record last updated
June 28, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Pain in young children has been universally under-recognized due to their inability to describe or localize pain. Improvements in pharmacological interventions are necessary to optimize patient and family experience and allow for successful and efficient procedure completion. This is the first study that will compare three intranasal medications (Intranasal Midazolam, Dexmedetomidine, and Ketamine) to evaluate the length of stay after medication administration along with patient and provider satisfaction. The objective of this study is to demonstrate superior intranasal anxiolysis for pediatric laceration repairs with the shortest emergency department stay and highest patient and provider satisfaction. Based on previous studies and medication pharmacokinetics, we hypothesize that Intranasal Ketamine will have the shortest Emergency Department (ED) stay followed by Midazolam and then Dexmedetomidine with the longest stay; however, Dexmedetomidine will have the highest patient and provider satisfaction followed by Ketamine and then Midazolam.

Being studied: Intranasal Midazolam; Intranasal Dexmedetomidine; Intranasal Ketamine

Conditions: Laceration of Skin; Anxiety; Discharge Time

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Age 1-5 years old
  • Presents to the ED for suture repair for lacerations less than or equal to 5cm in length
  • Parent(s)/Caregiver(s) speak English

Exclusion Criteria

  • Younger than 12 months of age or older than 5 years old
  • Suture repair needed for lacerations are greater than 5cm in length
  • Known allergy or adverse effect to Midazolam, Dexmedetomidine, Ketamine, or any other sedatives
  • Any abnormal vital signs for age, especially heart rate and blood pressure
  • History of Cardiac, respiratory, renal, or liver disease
  • Known electrolyte abnormalities
  • Any ocular trauma, nasal injury, nasal deformity, significant nasal congestion, abnormalities in the nasal or oral mucosa, facial deformity, or facial injury
  • Home medications include beta blockers or any other blood pressure lowering agents Classified American Society of Anesthesiologists III and above
  • Known or anticipated difficult airway
  • Abnormal neurological exam
  • Parent(s)/Caregiver(s) do not speak English

Recruiting US locations

  • University of Oklahoma Health Sciences Center

    Oklahoma City, OK 73104

    Site contact: Gavely Toor, DO · Gavely-Toor@ouhsc.edu

Study contacts (from the official record)

  • Gavely Toor, DO · 405-271-2429 · gavely-toor@ouhsc.edu
All mental health studies in Oklahoma →
IN Midazolam vs IN Dexmedetomidine vs IN Ketamine During Minimal… (NCT05934669) | Bored Studies