IN Ketamine Vs IN Midazolam and Fentanyl for Abscess I&D
Condition: Abscess; Pain
MeSH terms: Abscess
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): intranasal ketamine; intranasal fentanyl; intranasal midazolam
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Versed
Intervention MeSH terms: Midazolam; Fentanyl; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment