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

NCT05934669 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 15872
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  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

  Day 1

Study Arms (3)

Intranasal Midazolam

EXPERIMENTAL

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.

Drug: Intranasal Midazolam

Intranasal Dexmedetomidine

EXPERIMENTAL

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.

Drug: Intranasal Dexmedetomidine

Intranasal Ketamine

EXPERIMENTAL

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.

Drug: Intranasal Ketamine

Interventions

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.

Also known as: Intranasal Versed

Intranasal Midazolam

Intranasal Dexmedetomidine DRUG

See above

Also known as: Intranasal Precedex

Intranasal Dexmedetomidine

Intranasal Ketamine DRUG

See above

Intranasal Ketamine

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Related Publications (16)

• Shaw KN, Bachur RG, editors. Fleisher & Ludwig's Textbook of Pediatric Emergency Medicine. 8th Edition. Philadelphia: Wolters Kluwer, e129, 2021

  BACKGROUND

• Zempsky WT, Cravero JP; American Academy of Pediatrics Committee on Pediatric Emergency Medicine and Section on Anesthesiology and Pain Medicine. Relief of pain and anxiety in pediatric patients in emergency medical systems. Pediatrics. 2004 Nov;114(5):1348-56. doi: 10.1542/peds.2004-1752.

  PMID: 15520120 BACKGROUND

• Everitt IJ, Barnett P. Comparison of two benzodiazepines used for sedation of children undergoing suturing of a laceration in an emergency department. Pediatr Emerg Care. 2002 Apr;18(2):72-4. doi: 10.1097/00006565-200204000-00002.

  PMID: 11973494 BACKGROUND

• Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT. Bioavailability of dexmedetomidine after intranasal administration. Eur J Clin Pharmacol. 2011 Aug;67(8):825-31. doi: 10.1007/s00228-011-1002-y. Epub 2011 Feb 12.

  PMID: 21318594 BACKGROUND

• Yuen VM, Hui TW, Irwin MG, Yao TJ, Wong GL, Yuen MK. Optimal timing for the administration of intranasal dexmedetomidine for premedication in children. Anaesthesia. 2010 Sep;65(9):922-9. doi: 10.1111/j.1365-2044.2010.06453.x.

  PMID: 20645951 BACKGROUND

• Carlone G, Trombetta A, Amoroso S, Poropat F, Barbi E, Cozzi G. Intramuscular Dexmedetomidine, a Feasible Option for Children With Autism Spectrum Disorders Needing Urgent Procedural Sedation. Pediatr Emerg Care. 2019 Jun;35(6):e116-e117. doi: 10.1097/PEC.0000000000001776. No abstract available.

  PMID: 31157751 BACKGROUND

• Azizkhani R, Heydari F, Ghazavi M, Riahinezhad M, Habibzadeh M, Bigdeli A, Golshani K, Majidinejad S, Mohammadbeigi A. Comparing Sedative Effect of Dexmedetomidine versus Midazolam for Sedation of Children While Undergoing Computerized Tomography Imaging. J Pediatr Neurosci. 2020 Jul-Sep;15(3):245-251. doi: 10.4103/jpn.JPN_107_19. Epub 2020 Nov 6.

  PMID: 33531939 BACKGROUND

• Guthrie AM, Baum RA, Carter C, Dugan A, Jones L, Tackett T, Bailey AM. Use of Intranasal Ketamine in Pediatric Patients in the Emergency Department. Pediatr Emerg Care. 2021 Dec 1;37(12):e1001-e1007. doi: 10.1097/PEC.0000000000001863.

  PMID: 31290798 BACKGROUND

• Neville DN, Hayes KR, Ivan Y, McDowell ER, Pitetti RD. Double-blind Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department. Acad Emerg Med. 2016 Aug;23(8):910-7. doi: 10.1111/acem.12998.

  PMID: 27129606 BACKGROUND

• Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.

  PMID: 9322455 BACKGROUND

• Gyanesh P, Haldar R, Srivastava D, Agrawal PM, Tiwari AK, Singh PK. Comparison between intranasal dexmedetomidine and intranasal ketamine as premedication for procedural sedation in children undergoing MRI: a double-blind, randomized, placebo-controlled trial. J Anesth. 2014 Feb;28(1):12-8. doi: 10.1007/s00540-013-1657-x. Epub 2013 Jun 26.

  PMID: 23800984 BACKGROUND

• Surendar MN, Pandey RK, Saksena AK, Kumar R, Chandra G. A comparative evaluation of intranasal dexmedetomidine, midazolam and ketamine for their sedative and analgesic properties: a triple blind randomized study. J Clin Pediatr Dent. 2014 Spring;38(3):255-61. doi: 10.17796/jcpd.38.3.l828585807482966.

  PMID: 25095322 BACKGROUND

• Cravero JP, Askins N, Sriswasdi P, Tsze DS, Zurakowski D, Sinnott S. Validation of the Pediatric Sedation State Scale. Pediatrics. 2017 May;139(5):e20162897. doi: 10.1542/peds.2016-2897.

  PMID: 28557732 BACKGROUND

• Tug A, Hanci A, Turk HS, Aybey F, Isil CT, Sayin P, Oba S. Comparison of Two Different Intranasal Doses of Dexmedetomidine in Children for Magnetic Resonance Imaging Sedation. Paediatr Drugs. 2015 Dec;17(6):479-85. doi: 10.1007/s40272-015-0145-1.

  PMID: 26323489 BACKGROUND

• Marra P, Di Stadio A, Colacurcio V, Scarpa A, La Mantia I, Salzano FA, De Luca P. Sedation with Intranasal Dexmedetomidine in the Pediatric Population for Auditory Brainstem Response Testing: Review of the Existing Literature. Healthcare (Basel). 2022 Feb 1;10(2):287. doi: 10.3390/healthcare10020287.

  PMID: 35206901 BACKGROUND

• Lewis J, Bailey CR. Intranasal dexmedetomidine for sedation in children; a review. J Perioper Pract. 2020 Jun;30(6):170-175. doi: 10.1177/1750458919854885. Epub 2019 Jun 27.

  PMID: 31246159 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ryan Mckee, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gavely Toor, DO

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A double blind randomized study. Except for the pharmacist, all treating ED physicians, nurses, patients, patients' caregivers/guardians, ancillary staff, and data analysts will be blinded to the medication administered to the patient. 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After patient enrollment, a nurse will assign a chronological number from 1 to 90. The pharmacist will randomly divide all 90 subjects into 3 even groups to receive either medication A, B, or C. The pharmacist will dispense the medication in a 1ml syringe to the chronological number provided in the order. The nurse will fill out a mYPAS scale to assess the patient's anxiety level and then administer the medication. After 30 minutes, the physician will determine subject readiness and perform laceration repair. The patient's vitals will be monitored every 5 minutes. At the end of the procedure, both the physician and the parent will answer a question using a Likert scale and the nurse will fill out another mYPAS scale. After the procedure, the patient will be monitored in the ED for any adverse effects and will be discharged home once the patient meets established discharge criteria. The nurse will document the time the patient is discharged.

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 7, 2023
• Study Start: November 14, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Three years after the completion of the study

Locations

US (1)