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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02635282
Recruitment Status : Completed
First Posted : December 18, 2015
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Cynthia Copley, University of Tennessee Health Science Center

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.

Condition or disease Intervention/treatment Phase
Abscess Pain Drug: intranasal ketamine Drug: intranasal fentanyl Drug: intranasal midazolam Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2016
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : March 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

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 Name: Versed

Experimental: IN ketamine
group of patients who are randomized to receive intranasal ketamine
Drug: intranasal ketamine



Primary Outcome Measures :
  1. Change in pain score measured utilizing the Faces Pain Scale-Revised [ Time Frame: before medication administered and at 30 minutes after medication administration ]
    The Faces Pain Scale-Revised will be used for children ages 3-7 years

  2. Change in pain score measured utilizing the numeric pain rating scale [ Time Frame: before medication administered and at 30 minutes after medication administration ]
    The numeric pain rating scale will be used in children ages 8-17 years


Secondary Outcome Measures :
  1. Vital sign measurements [ Time Frame: before medication administered and at 15 and 30 minutes after medication administration ]
    Temperature, heart rate, respiratory rate, oxygen saturation, and blood pressure will be measured

  2. Sedation score using the University of Michigan Sedation Scale [ Time Frame: before medication administered and at 15 and 30 minutes after medication administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635282


Locations
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United States, Tennessee
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
University of Tennessee Health Science Center
Publications of Results:
Other Publications:
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Responsible Party: Cynthia Copley, Principal Investigator, Pediatric Emergency Medicine Fellow, University of Tennessee Health Science Center
ClinicalTrials.gov Identifier: NCT02635282    
Other Study ID Numbers: 15-04113-FB
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Abscess
Suppuration
Infections
Inflammation
Pathologic Processes
Fentanyl
Midazolam
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents