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

Primary Purpose

Facial Laceration, Anxiety

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Intranasal Fentanyl Spray and Intranasal Midazolam Spray

Intranasal Midazolam Spray

About this trial

This is an interventional treatment trial for Facial Laceration focused on measuring Laceration repair, Facial laceration, Anxiety, Midazolam, Fentanyl

Eligibility Criteria

1 Year - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intranasal Midazolam and Intranasal Fentanyl

Intranasal Midazolam

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Provider Satisfaction with Procedural Sedation (Visual Analog Score)

VAS (visual analog score) completed by blinded researcher (provider) to rate satisfaction with level of sedation and ease of procedure. The scale will range from 0 (unsatisfied) to 100 (very satisfied).

Parent Satisfaction with Anxiolysis (Visual Analog Scale)

VAS (visual analog score) completed by parent to rate satisfaction with level of anxiolysis for procedure. The scale will range from 0 (unsatisfied) to 100 (very satisfied).

Rate of Treatment Failure

Failure of intervention to provide appropriate anxiolysis and need for IV sedation

Duration of Procedure

Duration of procedure from positioning to last suture placement, to be recorded by blinded researcher (provider)

Full Information

NCT ID

NCT04745260

First Posted

January 31, 2021

Last Updated

February 6, 2021

Sponsor

University of Texas at Austin

1. Study Identification

Unique Protocol Identification Number

NCT04745260

Brief Title

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

Official Title

A Randomized Controlled Trial of Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Analgesia and Anxiolysis During Pediatric Facial Laceration Repair

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2021 (Anticipated)

Primary Completion Date

November 1, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study will be a single blind (blinded observer) randomized control trial to evaluate the efficacy of the combination of intranasal fentanyl and intranasal midazolam compared to intranasal midazolam alone for analgesia and anxiolysis during pediatric facial laceration repair.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Facial Laceration, Anxiety

Keywords

Laceration repair, Facial laceration, Anxiety, Midazolam, Fentanyl

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intranasal Midazolam and Intranasal Fentanyl

Arm Type

Experimental

Arm Description

Arm Title

Intranasal Midazolam

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Intranasal Fentanyl Spray and Intranasal Midazolam Spray

Other Intervention Name(s)

Versed

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Intranasal Midazolam Spray

Other Intervention Name(s)

Versed

Intervention Description

Intranasal Midazolam 0.3mg/kg

Primary Outcome Measure Information:

Title

Modified Yale Preoperative Anxiety Score (mYPAS)

Description

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.

Time Frame

Pre-procedure

Secondary Outcome Measure Information:

Title

Provider Satisfaction with Procedural Sedation (Visual Analog Score)

Description

Time Frame

Immediately after the procedure

Title

Parent Satisfaction with Anxiolysis (Visual Analog Scale)

Description

VAS (visual analog score) completed by parent to rate satisfaction with level of anxiolysis for procedure. The scale will range from 0 (unsatisfied) to 100 (very satisfied).

Time Frame

Immediately after the procedure

Title

Rate of Treatment Failure

Description

Failure of intervention to provide appropriate anxiolysis and need for IV sedation

Time Frame

Immediately after the procedure

Title

Duration of Procedure

Description

Duration of procedure from positioning to last suture placement, to be recorded by blinded researcher (provider)

Time Frame

Immediately after the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Facial laceration requiring repair with sutures English or Spanish-speaking parent/guardian Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brittany J DiFabio, MD

Phone

512-324-0093

brittany.difabio@ascension.org

First Name & Middle Initial & Last Name or Official Title & Degree

Matthew Wilkinson, MD

Phone

512-324-0093

mhwilkinson@ascension.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brittany J DiFabio, MD

Organizational Affiliation

University of Texas at Austin

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23109683

Citation

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.

Results Reference

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PubMed Identifier

10629683

Citation

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.

Results Reference

background

PubMed Identifier

29720907

Citation

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.

Results Reference

background

PubMed Identifier

30146398

Citation

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.

Results Reference

background

PubMed Identifier

9322455

Citation

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.

Results Reference

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PubMed Identifier

12472704

Citation

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.

Results Reference

background

PubMed Identifier

27129606

Citation

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.

Results Reference

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

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