Ketamine as an Adjuvant Therapy for Acute Vaso Occlusive Crisis in Pediatric Patients With Sickle Cell Disease

Ketamine

Brief Summary

The primary objective of the proposed study is to determine the potential role of Ketamine as an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in acute (VOC).

Intervention / Treatment

  • Ketamine (DRUG)
    Single bolus of Ketamine .25 milligrams per kilogram of weight.

Condition or Disease

  • Sickle Cell Disease

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 3 Years to 17 Years
    Enrollment: 20 (ESTIMATED)
    Funded by: Other
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Jul 01, 2016
    Primary Completion: Jul 01, 2018 ESTIMATED
    Completion Date: Jul 01, 2018 ESTIMATED
    Study First Posted: Jun 15, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jun 10, 2016

    Sponsors / Collaborators

    Lead Sponsor: Augusta University
    Lead sponsor is responsible party
    Responsible Party: N/A

    The primary objective of the proposed study is to determine the potential role of Ketamine as an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in acute (VOC). Our study design is as follows: Prospective observational study of 20 pediatric sickle cell disease patients with refractory pain to conventional analgesic regimens seen in the pediatric emergency medicine department. Consenting patients with refractory pain meeting inclusion criteria will be given a single intravenous bolus of Ketamine at a set dosage of 0.25 milligrams per kilogram of weight. Participants' perception of pain will then be recorded using standard pain scoring scales (FLACC score). Physiologic criteria such as heart rate, blood pressure, blood oxygen saturation, total analgesic pharmacologic requirements for adequate analgesia during hospitalization, and duration of hospitalization will be measured. Observational study group will continue to get standard of care outside of single bolus of Ketamine. 48 hour follow up after hospital discharge will be obtained to assess degree of pain control and general clinical status.

    Participant Groups

    • adjuvant to standard of care

    Eligibility Criteria

    Sex: All
    Minimum Age: 3
    Maximum Age: 17
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Pediatric patients (\> 3 yrs and \<18yrs) with a previous diagnosis of sickle cell disease (including Hgb S Beta Thalassemia +, Hgb S Alpha Thalassemia, Hgb S HPFH) ) seen in the pediatric emergency room setting for acute vaso-occlusive pain crisis.

    Exclusion Criteria:

    * Patients not to have sequelae indicative of complicated disease outside of acute VOC:

    1. Acute chest syndrome (new pulmonary infiltrate and hypoxemia)
    2. Aplastic Episode
    3. Evidence of infection
    4. Pregnancy or CHF
    5. Fever (\> 38.4)
    6. Cholangitis or cholecystitis
    7. Hypoxia (SaO2 \<90% on RA), or O2 saturation decrease of more than 5% from patient's baseline
    8. Unstable Vital Signs
    9. Patients who have received intravenous pain medicine within 24 hours of visit to the emergency department.
    10. History of allergic reaction or serious reaction to Ketamine.
    11. History of significant psychiatric illness
    12. Patients with no refractory pain after receiving conventional analgesia regimen per protocol.

    Primary Outcomes

    • reduction in refractory pain

    More Details

    NCT Number: NCT02801292
    Acronym: KSickle
    Other IDs: 917282
    Study URL: https://clinicaltrials.gov/study/NCT02801292
    Last updated: Sep 29, 2023