Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Pediatric Facial Laceration Repair

NCT04745260 | Unknown

• 1 other identifier: 2020040016
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to compare the effectiveness of a combination of intranasal fentanyl and intranasal midazolam to intranasal midazolam alone for analgesia and anxiolysis in patients presenting for facial laceration repair in the pediatric emergency department.

Conditions

Facial Laceration; Anxiety

Keywords

Laceration repair; Facial laceration; Anxiety; Midazolam; Fentanyl

Outcome Measures

Primary Outcomes (1)

• Modified Yale Preoperative Anxiety Score (mYPAS)

  mYPAS score at time of positioning, to be completed by blinded researcher (provider) to assess anxiety level. Scores range from 22.5 to 100, with higher scores indicating greater anxiety.

  Pre-procedure

Secondary Outcomes (4)

• Provider Satisfaction with Procedural Sedation (Visual Analog Score)

  Immediately after the procedure

• Parent Satisfaction with Anxiolysis (Visual Analog Scale)

  Immediately after the procedure

• Rate of Treatment Failure

  Immediately after the procedure

• Duration of Procedure

  Immediately after the procedure

Study Arms (2)

Intranasal Midazolam and Intranasal Fentanyl

EXPERIMENTAL

Study participants assigned to the combination (experimental) group will receive a weight-based dose of intranasal Fentanyl (50mcg/mL concentration at 2mcg/kg up to 100mcg) followed by intranasal Midazolam (5mg/mL concentration at 0.2mg/kg up to 10mg) using a mucosal atomizer device (1mL syringe with an attached atomizer).

Drug: Intranasal Fentanyl Spray and Intranasal Midazolam Spray

Intranasal Midazolam

ACTIVE COMPARATOR

Study participants assigned to the control (active comparator) group will receive only intranasal Midazolam (5mg/mL concentration at 0.3mg/kg up to 10mg) using a mucosal atomizer device (1mL syringe with an attached atomizer).

Drug: Intranasal Midazolam Spray

Interventions

Intranasal Fentanyl Spray and Intranasal Midazolam Spray DRUG

Intranasal Fentanyl 2mcg/kg and Intranasal Midazolam 0.2mg/kg

Also known as: Versed

Intranasal Midazolam and Intranasal Fentanyl

Intranasal Midazolam Spray DRUG

Intranasal Midazolam 0.3mg/kg

Also known as: Versed

Intranasal Midazolam

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Facial laceration requiring repair with sutures
• English or Spanish-speaking parent/guardian

You may not qualify if:

• Lacerations requiring IV sedation or subspecialist involvement
• Patient has other injuries requiring medical attention
• Patient has vital sign instability, per physician discretion
• Patient has autism spectrum disorder
• Patient has allergies to either medication

Sponsors & Collaborators

• University of Texas at Austin: lead

Related Publications (7)

• Fein JA, Zempsky WT, Cravero JP; Committee on Pediatric Emergency Medicine and Section on Anesthesiology and Pain Medicine; American Academy of Pediatrics. Relief of pain and anxiety in pediatric patients in emergency medical systems. Pediatrics. 2012 Nov;130(5):e1391-405. doi: 10.1542/peds.2012-2536. Epub 2012 Oct 29.

  PMID: 23109683 BACKGROUND

• Kennedy RM, Luhmann JD. The "ouchless emergency department". Getting closer: advances in decreasing distress during painful procedures in the emergency department. Pediatr Clin North Am. 1999 Dec;46(6):1215-47, vii-viii. doi: 10.1016/s0031-3955(05)70184-x.

  PMID: 10629683 BACKGROUND

• Miller JL, Capino AC, Thomas A, Couloures K, Johnson PN. Sedation and Analgesia Using Medications Delivered via the Extravascular Route in Children Undergoing Laceration Repair. J Pediatr Pharmacol Ther. 2018 Mar-Apr;23(2):72-83. doi: 10.5863/1551-6776-23.2.72.

  PMID: 29720907 BACKGROUND

• Ryan PM, Kienstra AJ, Cosgrove P, Vezzetti R, Wilkinson M. Safety and effectiveness of intranasal midazolam and fentanyl used in combination in the pediatric emergency department. Am J Emerg Med. 2019 Feb;37(2):237-240. doi: 10.1016/j.ajem.2018.05.036. Epub 2018 May 17.

  PMID: 30146398 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

• Kogan A, Katz J, Efrat R, Eidelman LA. Premedication with midazolam in young children: a comparison of four routes of administration. Paediatr Anaesth. 2002 Oct;12(8):685-9. doi: 10.1046/j.1460-9592.2002.00918.x.

  PMID: 12472704 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

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Brittany J DiFabio, MD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany J DiFabio, MD

CONTACT

512-324-0093; brittany.difabio@ascension.org

Matthew Wilkinson, MD

CONTACT

512-324-0093; mhwilkinson@ascension.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A non-blinded researcher (physician) will determine the group to which the patient is assigned and order the medication(s) according to the assigned group. A separate blinded researcher (physician) will then perform the laceration repair, mYPAS, and post-procedure evaluations. The non-blinded researcher, nurse, parent, and patient will be advised not to disclose which medication(s) were administered to ensure blinding of the provider performing the laceration repair and assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Emergency Medicine Fellow Physician

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 9, 2021
• Study Start: March 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 31, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share