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IN Ketamine Vs IN Midazolam and Fentanyl for Abscess I&D

Primary Purpose

Abscess, Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
intranasal ketamine
intranasal fentanyl
intranasal midazolam
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abscess

Eligibility Criteria

3 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of abscess with planned incision and drainage of a single abscess

Exclusion Criteria:

  • Fast Track patients
  • Patients who have received an opioid analgesic within the previous 4 hours of time of enrollment in study
  • Patients with parent or legal guardian not present to give informed consent for enrollment in study
  • Non-English speaking patients and/or parent
  • Patients with a contraindication for the administration of intranasal medication (nasal trauma, aberrant nasal anatomy)
  • Patients with ocular injuries
  • Patients with a known allergy to ketamine, fentanyl, and/or midazolam
  • Pregnant females
  • Patients with history of seizure disorders

Sites / Locations

  • Le Bonheur Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IN fentanyl and midazolam

IN ketamine

Arm Description

group of patients who are randomized to receive intranasal fentanyl and midazolam

group of patients who are randomized to receive intranasal ketamine

Outcomes

Primary Outcome Measures

Change in pain score measured utilizing the Faces Pain Scale-Revised
The Faces Pain Scale-Revised will be used for children ages 3-7 years
Change in pain score measured utilizing the numeric pain rating scale
The numeric pain rating scale will be used in children ages 8-17 years

Secondary Outcome Measures

Vital sign measurements
Temperature, heart rate, respiratory rate, oxygen saturation, and blood pressure will be measured
Sedation score using the University of Michigan Sedation Scale

Full Information

First Posted
December 9, 2015
Last Updated
March 23, 2017
Sponsor
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT02635282
Brief Title
IN Ketamine Vs IN Midazolam and Fentanyl for Abscess I&D
Official Title
Intranasal Ketamine Versus Intranasal Midazolam Plus Fentanyl in Treating Pain Associated With Incision and Drainage of Abscesses in the Pediatric Emergency Department: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
March 23, 2017 (Actual)
Study Completion Date
March 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tennessee

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The general objective of this study is to determine whether intranasal ketamine should be incorporated into formulary as an option to treat pain during minor procedures in the pediatric emergency department.
Detailed Description
In the pediatric emergency department, one of the main goals in patient care is to provide adequate pain management. Many patients present to the emergency department with conditions or injuries that cause acute or chronic pain. Health care providers routinely aim to treat patients' pain in a timely manner after arrival to the emergency department. A common scenario occurs when a patient presents with a condition in which treatment will require that a potentially painful or anxiety-provoking procedure will be performed in the ED, and providers also strive to treat this pain and anxiety accordingly. There are several different methods for treating pain and anxiety, including multiple types of medications, which can be given orally, intravenously, intramuscularly, or intranasally. The use of intranasal medications for the treatment of pain and anxiety has been steadily increasing over the last decade, and this has been particularly helpful in the pediatric population. There are several advantages of using intranasal medications, including rapid onset, ease of administration, and lack of need for IV access. At this time, this pediatric emergency department uses two different medications via the intranasal route of administration: fentanyl, a synthetic opiate, and midazolam, a benzodiazepine, which are used for pain control and anxiolysis, respectively, and these two medications are frequently used together. The objective of this study is to introduce ketamine as a third medication for intranasal use and to observe its effects on pain control; this medication is currently used either intravenously or intramuscularly in the investigator's ED. Ketamine is an anesthetic that has properties of analgesia and amnesia and has a generally favorable side effect profile. This study will observe the effects of using a medication that is already widely used in the investigator's ED, but it will be used via a different route of administration, offering advantages over other options. In this study, patients will be enrolled who have been diagnosed with a soft tissue abscess that will be treated with incision and drainage in the ED. Patients in one group will be given a dose of intranasal ketamine at a predetermined dose, and measured variables will include pain score, vital signs, patient and/or parent satisfaction, adverse effects, length of stay, and need for additional doses of ketamine or additional medications. This group of patients will be compared with another group of patients who will be given intranasal fentanyl and intranasal midazolam using a randomization through the RedCap system. The investigators hypothesize that the use of intranasal ketamine in this PED for treating pain associated with the minor procedure of incision and drainage of a soft tissue abscess will provide satisfactory pain control in these patients while offering advantages over other treatment options, as compared with patients treated with the current standard intranasal medications.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IN fentanyl and midazolam
Arm Type
Active Comparator
Arm Description
group of patients who are randomized to receive intranasal fentanyl and midazolam
Arm Title
IN ketamine
Arm Type
Experimental
Arm Description
group of patients who are randomized to receive intranasal ketamine
Intervention Type
Drug
Intervention Name(s)
intranasal ketamine
Intervention Type
Drug
Intervention Name(s)
intranasal fentanyl
Intervention Type
Drug
Intervention Name(s)
intranasal midazolam
Other Intervention Name(s)
Versed
Primary Outcome Measure Information:
Title
Change in pain score measured utilizing the Faces Pain Scale-Revised
Description
The Faces Pain Scale-Revised will be used for children ages 3-7 years
Time Frame
before medication administered and at 30 minutes after medication administration
Title
Change in pain score measured utilizing the numeric pain rating scale
Description
The numeric pain rating scale will be used in children ages 8-17 years
Time Frame
before medication administered and at 30 minutes after medication administration
Secondary Outcome Measure Information:
Title
Vital sign measurements
Description
Temperature, heart rate, respiratory rate, oxygen saturation, and blood pressure will be measured
Time Frame
before medication administered and at 15 and 30 minutes after medication administration
Title
Sedation score using the University of Michigan Sedation Scale
Time Frame
before medication administered and at 15 and 30 minutes after medication administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of abscess with planned incision and drainage of a single abscess Exclusion Criteria: Fast Track patients Patients who have received an opioid analgesic within the previous 4 hours of time of enrollment in study Patients with parent or legal guardian not present to give informed consent for enrollment in study Non-English speaking patients and/or parent Patients with a contraindication for the administration of intranasal medication (nasal trauma, aberrant nasal anatomy) Patients with ocular injuries Patients with a known allergy to ketamine, fentanyl, and/or midazolam Pregnant females Patients with history of seizure disorders
Facility Information:
Facility Name
Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22305630
Citation
Bailey B, Gravel J, Daoust R. Reliability of the visual analog scale in children with acute pain in the emergency department. Pain. 2012 Apr;153(4):839-842. doi: 10.1016/j.pain.2012.01.006. Epub 2012 Feb 4.
Results Reference
background
PubMed Identifier
23365053
Citation
Afridi SK, Giffin NJ, Kaube H, Goadsby PJ. A randomized controlled trial of intranasal ketamine in migraine with prolonged aura. Neurology. 2013 Feb 12;80(7):642-7. doi: 10.1212/WNL.0b013e3182824e66. Epub 2013 Jan 30.
Results Reference
result
PubMed Identifier
24127709
Citation
Andolfatto G, Willman E, Joo D, Miller P, Wong WB, Koehn M, Dobson R, Angus E, Moadebi S. Intranasal ketamine for analgesia in the emergency department: a prospective observational series. Acad Emerg Med. 2013 Oct;20(10):1050-4. doi: 10.1111/acem.12229.
Results Reference
result
PubMed Identifier
24987995
Citation
Del Pizzo J, Callahan JM. Intranasal medications in pediatric emergency medicine. Pediatr Emerg Care. 2014 Jul;30(7):496-501; quiz 502-4. doi: 10.1097/PEC.0000000000000171.
Results Reference
result

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IN Ketamine Vs IN Midazolam and Fentanyl for Abscess I&D

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