Clinical TrialChronic PainKetaminePlaceboWithdrawn

Single-dose Ketamine for the Reduction of Pain and Depression in the Emergency Department

Randomised, parallel, active placebo-controlled Phase II/III trial (n=120 planned) assessing single IV ketamine (0.3 mg/kg) plus midazolam versus placebo plus midazolam for acute pain and depressive symptoms in ED patients.

Target Enrollment
120 participants
Study Type
Phase II/III interventional
Design
Randomized, quadruple Blind

Detailed Description

This parallel-group, randomised, quadruple-blind study will compare a single IV ketamine infusion (0.3 mg/kg) co-administered with midazolam to placebo plus midazolam in medically stable adults presenting to emergency departments with acute pain.

Outcomes include repeated measures of pain and mood in the ED (every 30 minutes), recording of analgesics given, and follow-up assessments of pain, mood, and analgesic use at 7 and 14 days post-discharge.

Study Protocol

Preparation

sessions

Dosing

1 sessions
120 min each

Integration

sessions

Study Arms & Interventions

Ketamine + midazolam

experimental

Single IV infusion of ketamine co-administered with midazolam.

Interventions

  • Ketamine0.3 mg/kg
    via IV• single dose

    Ketamine 0.3 mg/kg IV single dose; midazolam co-administered (dose not specified).

  • Compound
    via IV• single dose

    Midazolam co-administered; dose not specified.

Placebo + midazolam

active comparator

Midazolam with placebo infusion (active placebo control).

Interventions

  • Compound
    via IV• single dose

    Midazolam administered (dose not specified).

  • Placebo
    via IV• single dose

    Placebo infusion matching ketamine.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Adults between the ages of 18-65
  • 2. A chief complaint of painful condition (pain score ≥ 5 on the numeric rating scale [NRS] from 0-10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable")
  • 3. Expected to be in the ED for at least 2 hours

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Non-English speaking
  • 2. Not medically suitable for ketamine per treating MD (e.g. medical condition where ketamine is contraindicated; ketamine or midazolam may be unsafe, e.g., known sensitivity, glaucoma, or other concerns)
  • 3. Not alert and oriented
  • 4. Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
  • 5. Seeking treatment due to a mental health or substance use disorder
  • 6. History of chronic opioid use
  • 7. Prescribed opioid use within the past 24 hours
  • 8. Any use of recreational narcotics throughout lifetime
  • 9. Sensitivity or allergy or intolerance to ketamine, opioids, and/or benzodiazepines
  • 10. Weight > 170kg (375 lbs)
  • 11. Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)
  • 12. Pregnancy
  • 13. Prisoner

Study Details

  • Status
    Withdrawn
  • Phase
    Phase IIPhase III
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment120 participants
  • Timeline
    Start: 2019-01-12
    End: 2020-05-02
  • Compounds
    KetaminePlacebo
  • Topic
    Chronic Pain

Locations

United States

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