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

University of Tennessee

Status and phase: Completed; Phase 4

Conditions: Pain; Abscess

Treatments: Drug: intranasal fentanyl; Drug: intranasal ketamine; Drug: intranasal midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT02635282

15-04113-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

IN fentanyl and midazolam

Active Comparator group

Description:

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

Treatment:

Drug: intranasal fentanyl

Drug: intranasal midazolam

IN ketamine

Experimental group

Description:

group of patients who are randomized to receive intranasal ketamine

Treatment:

Drug: intranasal ketamine