Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department
Condition: Acute Pain; Pain
MeSH terms: Emergencies; Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigates the use of low doses of ketamine, along with opiate pain medication,
      is more effective at controlling the acute pain of patients in the emergency department than
      opiate pain medication alone. In addition, this study examines whether patients treated with
      low doses of ketamine, along with opiate pain medication, will require less opiate pain
      medication to control their pain, and whether these patients are equally happy with their
      pain control as patients who receive only opiate pain medication.
    

Detailed description: 
      This randomized, double blinded, placebo controlled study investigates the use of low-dose
      ketamine, in conjunction to standard opiate treatment, as compared to placebo plus standard
      opiate treatment, for acute painful conditions in the ED setting. The investigators
      hypothesize that patients treated with ketamine will require less opiate for similar levels
      of pain relief up to 2 hours from initiation of treatment, with similar levels of patient
      satisfaction and an acceptable side effect profile.

      Once seen by a physician, potential patients will receive provider-determined opiate
      treatment for their painful condition, prior to the informed consent process to ensure that
      treatment is not delayed. Once identified for inclusion, patients will receive informed
      consent and, upon consent, will subsequently be randomized through block randomization into
      one of two study groups. Each study group will contain at least 50 subjects. Randomization
      will be determined using a table of random numbers, using a restricted randomization scheme
      to ensure roughly equal numbers in each group. Group assignments will be sealed in opaque
      envelopes to be opened sequentially by the investigators. Group assignments will not indicate
      whether it is the treatment or the control group. At this time (T0), an initial NRS-11 score
      will be obtained. The NRS-11 is an 11-point scale on which patients rate their level of pain
      from 0 ("no pain") to 10 ("worst pain imaginable"). If, after initial analgesic, pain level
      is <6, patients will be asked again in 15 min. If at this time it is still <6, they will not
      proceed in the study. The intervention group will receive 0.1 mg/kg of ketamine given over 1
      minute, and the control group will receive an equivalent volume of normal saline; both groups
      will have received a provider-determined dose of opiate analgesia prior to enrollment. At
      thirty-minute intervals, subjects will be asked their level of pain, if they need more pain
      control and will be evaluated for the presence of side effects (hallucinations, dysphoria,
      weakness, diplopia, nausea, vomiting, dizziness, itching and bradypnea) as well as sedation
      as defined by Ramsay score of greater than 2. Repeat doses of pain medication will be given
      as 0.05 mg/kg morphine or equivalent dose of opioid analgesic. Total opiate dosage and number
      of repeat doses given at the end of 120 minutes will be recorded. At each time interval, as
      well as at the end of 120 minutes (T120), patient satisfaction with pain control will be
      recoded on the 4-point Likert scale, with 0 being "completely unsatisfied" and 3 being "very
      satisfied".
    

Intervention name(s): Ketamine; Normal Saline; opiate analgesic
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.1mg/kg ketamine IV; 1ml/kg normal saline placebo; 0.1mg/kg dose of morphine (or morphine equivalent) at 30 min time intervals based on patient pain score or more frequently upon request
Other intervention name(s): Ketalar; NS, saline
Intervention MeSH terms: Ketamine; Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment