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

Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Age Range:3 - 17
Start Date:August 2016
Contact:Cynthia R Copley, MD

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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

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.

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

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
We found this trial at
Memphis, Tennessee 38103
Memphis, TN
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