Intranasal Ketamine For Pain Control In Patients With Sickle Cell Disease And Vaso-occlusive Episode (VOE) In The PED

Ketamine

Brief Summary

This will be a descriptive cohort study of intranasal ketamine as the initial analgesic for children with sickle cell disease who present to the pediatric emergency department with vaso-occlusive crisis and are awaiting intravenous line placement.

Intervention / Treatment

Enrolled patients will receive one dose of Intranasal Ketamine dosed at 1mg/kg (Ketamine 500mg/10 mL solution) after triage while waiting for IV placement (max 50mg). This is an observational study.
  • Intranasal ketamine (DRUG)
    Patients with vaso-occlusive episode and sickle cell disease in moderate to severe pain determined at triage will receive intranasal ketamine while awaiting IV placement.

Condition or Disease

  • Sickle Cell Disease
  • Vaso-Occlusive Pain Episode in Sickle Cell Disease
  • Vaso-occlusive Crisis
  • Ketamine
  • Intranasal Ketamine
  • Analgesia

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 3 Years to 25 Years
    Enrollment: 40 (ESTIMATED)
    Funded by: Other
    Allocation: Non-Randomized
    Primary Purpose: Treatment

    Masking

    Patients and treating providers will be aware of the medication administration.

    Clinical Trial Dates

    Start date: Aug 21, 2020 ACTUAL
    Primary Completion: Jun 01, 2022 ESTIMATED
    Completion Date: Jun 01, 2022 ESTIMATED
    Study First Posted: Nov 05, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 31, 2021

    Sponsors / Collaborators

    Lead Sponsor: Abigail Nixon
    Responsible Party: Abigail Nixon

    Location

    Bronx, New York, USA

    This will be a prospective observational cohort involving patients 3 to 25 years of age who present to the Pediatric Emergency Department (PED) at Jacobi Medical Center with vaso-occlusive episode (VOE) in moderate-severe pain (FACES or numeric rating scale ≥5) as determined at triage. Currently, the standard of treatment for VOE at our institution is intravenous (IV) line placement and IV opioid analgesia. The patient will receive intranasal (IN) Ketamine as the first parental analgesic, so as to provide more immediate pain relief while they wait for IV placement and IV analgesia, for opioid pain control, which is currently the standard of care at our institution. The primary objective of this study is to describe the analgesic effect of IN ketamine in treating moderate-to-severe pain due to VOE in the pediatric ED as measured by a pain scale rating at various time intervals following administration. Secondary objectives are to describe the effect of IN ketamine on the need for additional doses of opioid medications, patient satisfaction and disposition.

    Participant Groups

    • Patients receiving "no intervention" will receive no intranasal ketamine while awaiting intravenous line placement for parenteral pain control.

    • Enrolled patients will receive one dose of Intranasal Ketamine dosed at 1mg/kg (Ketamine 500mg/10 mL solution) after triage while waiting for IV placement (max 50mg).

    Eligibility Criteria

    Sex: All
    Minimum Age: 3
    Maximum Age: 25
    Age Groups: Child / Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * History of Hemoglobin SS or SC disease
    * Age 3 years old to 25 years old presenting to the PED with vaso-occlusive with moderate-severe pain determined at triage as pain score (FACES or numeric rating scale) ≥ 5
    * Parent or patient willing to provide consent/assent
    * English speaking

    Exclusion Criteria:

    * Patient with concern for more severe complications including acute chest, splenic sequestration, sepsis, stroke, non-VOC pain, asthma exacerbation
    * Allergy to ketamine
    * GCS\<15
    * Obstructive nasal anatomy as per parent history
    * History of a psychiatric disorder
    * Pregnant patients will be excluded. Female patients \> 12 years old are routinely tested for pregnancy in our PED. Patients found to be pregnant will not be enrolled in study.

    Primary Outcomes

    • Change in pain rating from baseline to 30 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.

    • Change in pain rating from baseline to 30 minutes after initial administration of Ketamine. For patients 11 yrs and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.

    • Change in pain rating from baseline to 15 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.

    • Change in pain rating from baseline to 15 minutes after initial administration of Ketamine. For patients older than 11 years and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.

    • Change in pain rating from baseline to 60 minutes after initial administration of Ketamine. Pain assessments will be made using the Wong Baker FACES scale for children aged 10 years and younger. The Wong Baker/FACES scale is scored in multiples of 2 (each associated with a facial reaction), starting from a minimum of 0 to a maximum of 10.

    • Change in pain rating from baseline to 60 minutes after initial administration of Ketamine. For patients 11 years and older, pain will be assessed using the Numeric Rating Scale, which is a scale from a minimum of 0 to a maximum of 10.

    Secondary Outcomes

    • Number of opiate analgesic doses and a comparison of opiate equivalents/kilogram versus mean dose for prior visits (if the patient has been seen for VOE prior)

    • Patient/Parent satisfaction based on questionnaire. Patients will answer based on a 4 point scale (not happy at all/a little happy/happy\&satisfied/very happy)

    • Percentage of patients within each group who are admitted (vs discharged)

    • Percentage of patients within each group who have a return visit documented in the electronic medical record within 1 week of the ER visit.

    More Details

    NCT Number: NCT04150757
    Other IDs: 2019-10379
    Study URL: https://clinicaltrials.gov/study/NCT04150757
    Last updated: Sep 29, 2023