Recruiting

Midazolam vs. Dexmedetomidine vs. Ketamine

Sponsor:

University of Oklahoma

Code:

NCT05934669

Conditions

Laceration of Skin

Anxiety

Discharge Time

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: Accepted

Interventions

Intranasal Midazolam

Intranasal Dexmedetomidine

Intranasal Ketamine

Study Details

Brief summary:

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.

Conditions

Laceration of Skin

Anxiety

Discharge Time

Study ID

NCT05934669

Start date

Nov 14, 2023

Status verified date

Jun, 2024

Completion date

Jun, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 5

Healthy Volunteers: Accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intranasal Midazolam

Dose/Concentration: 5mg/ml of 0.4mg/kg Midazolam (max dose 10mg). Adverse side effects include respiratory depression and hypotension. Intranasal Midazolam is standard of care for minimal procedures in pediatric ED.

experimental: Intranasal Dexmedetomidine

Dose/Concentration: 100mcg/ml of 2mcg/kg Dexmedetomidine (max dose 100mcg). Adverse side effects include Hypotension and Bradycardia at high dosages. IV Dexmedetomidine is FDA approved and widely used in sedation. IN form isn't FDA approved; however, it has been approved to conduct research studies that have showed its efficacy in pre-operative settings, imaging-CT or MRI, dental procedures, and much more. Specifically, in a pediatric ED setting, Neville et al conducted a study comparing intranasal Dexmedetomidine and intranasal Midazolam prior to laceration repair in a pediatric emergency department and showed safe administration of Dexmedetomidine.

experimental: Intranasal Ketamine

Dose/Concentration: 100mg/ml of 3mg/kg Ketamine (max dose 100mg). Adverse side effect include Laryngospasm. IV Ketamine is FDA approved and widely used in procedural sedation in pediatric EDs. IN form isn't FDA approved in pediatric population; however, it has also been approved to conduct research studies especially in combination with other medications. Gutherie et al conducted a study demonstrating intranasal Ketamine providing safe and successful anxiolysis in pediatric patients in an ED setting.

Interventions

Intranasal Midazolam

Using a computer-generated randomization schedule by the research pharmacist, all 90 subjects will be divided into 3 even groups to receive either medication A (intranasal Midazolam), B (intranasal Dexmedetomidine), or C (intranasal Ketamine). Based on the randomization schedule, the pharmacist will dispense medication A, B, or C to the chronological number provided in the order. The total amount of the medication will be based on the patient's charted weight. Small volumes of less than 1ml per nostril are preferred for reliable absorption; therefore, the medication will be dispensed in a 1ml syringe and the barrel of the syringe will be covered by the pharmacist. All the syringes sent from the pharmacy will appear the same, regardless of the volume of the medication.

Intranasal Dexmedetomidine

See above

Intranasal Ketamine

See above

Primary outcome measure

  • The primary outcome will measure the time to discharge after intranasal medication administration [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Gavely Toor, DO

405-271-2429gavely-toor@ouhsc.edu

Locations

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Gavely Toor, DO

Gavely-Toor@ouhsc.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Jun 28, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2024-06-28.