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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Abscess
• Intervention / Treatment: Drug: intranasal fentanyl; Drug: intranasal midazolam; Drug: intranasal ketamine

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Le Bonheur Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IN fentanyl and midazolam; group of patients who are randomized to receive intranasal fentanyl and midazolam	Drug: intranasal fentanyl; Drug: intranasal midazolam; Other Names: Versed
Experimental: IN ketamine; group of patients who are randomized to receive intranasal ketamine	Drug: intranasal ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	before medication administered and at 30 minutes after medication administration
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	before medication administered and at 30 minutes after medication administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital sign measurements	Temperature, heart rate, respiratory rate, oxygen saturation, and blood pressure will be measured	before medication administered and at 15 and 30 minutes after medication administration
Sedation score using the University of Michigan Sedation Scale		before medication administered and at 15 and 30 minutes after medication administration

Collaborators and Investigators

• Sponsor: University of Tennessee Health Science Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): March 23, 2017
• Study Completion (Actual): March 23, 2017

Study Registration Dates

• First Submitted: December 9, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (Estimate): December 18, 2015

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Suppuration; Abscess; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Ketamine; Fentanyl; Midazolam
• Other Study ID Numbers: 15-04113-FB