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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

Tracking Information
First Submitted Date  ICMJE December 9, 2015
First Posted Date  ICMJE December 18, 2015
Last Update Posted Date March 27, 2017
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date March 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
  • 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 3-6 years
  • Change in pain score measured utilizing the visual analog scale [ Time Frame: before medication administered and at 30 minutes after medication administration ]
    The visual analog scale will be used in children ages 7-17 years
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • 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
  • Sedation score using the University of Michigan Sedation Scale [ Time Frame: before medication administered and at 15 and 30 minutes after medication administration ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
  • Vital sign measurements [ Time Frame: before medication administered and at 30 minutes after medication administration ]
    Temperature, heart rate, respiratory rate, oxygen saturation, and blood pressure will be measured
  • Sedation score using the University of Michigan Sedation Scale [ Time Frame: before medication administered and at 30 minutes after medication administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IN Ketamine Vs IN Midazolam and Fentanyl for Abscess I&D
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Abscess
  • Pain
Intervention  ICMJE
  • Drug: intranasal ketamine
  • Drug: intranasal fentanyl
  • Drug: intranasal midazolam
    Other Name: Versed
Study Arms  ICMJE
  • Active Comparator: IN fentanyl and midazolam
    group of patients who are randomized to receive intranasal fentanyl and midazolam
    Interventions:
    • Drug: intranasal fentanyl
    • Drug: intranasal midazolam
  • Experimental: IN ketamine
    group of patients who are randomized to receive intranasal ketamine
    Intervention: Drug: intranasal ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2017)
19
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2015)
100
Actual Study Completion Date  ICMJE March 23, 2017
Actual Primary Completion Date March 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02635282
Other Study ID Numbers  ICMJE 15-04113-FB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cynthia Copley, University of Tennessee Health Science Center
Study Sponsor  ICMJE University of Tennessee Health Science Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Tennessee Health Science Center
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP