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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-5
SponsorUniversity of Oklahoma

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intranasal Midazolam

    Drug

    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

    Drug

    See above

  • Intranasal Ketamine

    Drug

    See above

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Intranasal MidazolamExperimental treatment 1 intervention
Group B: Intranasal DexmedetomidineExperimental treatment 1 intervention
Group C: Intranasal KetamineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The primary outcome will measure the time to discharge after intranasal medication administration

The nurse will document the time the medication is administered and the time of discharge once the patient meets American Academy of Pediatrics (AAP) criteria of discharge. AAP discharge criteria includes cardiovascular function and airway potency satisfactory; arousable and protective reflexes are intact; able to talk appropriately for age; able to sit up appropriately for age; and state of hydration is adequate

Time frame
Day 1

Secondary outcomes

1

The secondary outcome will measure patient's anxiety using the previously validated scale mYPAS and physician and parent satisfaction using a 5-point Likert scale

Once the pharmacy dispenses the medication, the nurse will fill out an 18-point scale survey (Modified Yale Preoperative Anxiety Scale \[mYAS\]) to assess the patient's anxiety level. At the end of the procedure, both the physician and the parent will answer a question using a 5-point Likert scale and the nurse will fill out the same mYAS survey utilized prior to medication administration. The mYAS scale evaluates four domains including activity, vocalizations, emotional expressivity, and state of apparent arousal. The scoring is combined into a total anxiety score between 23.3 and 100 with a patient scoring less than or equal to 30 being categorized as not anxious. The scores on 5-point Likert scale are categorized into very satisfied, satisfied, no difference, unsatisfied, very unsatisfied for 5, 4, 3, 2, and 1, respectively.

Time frame
Day 1

Other outcomes

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