Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department
Information source: Brooke Army Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abdomen, Acute; Other Acute Pain; Flank Pain, Acute; Back Pain, Acute; Extremity Pain, Acute
Intervention: Ketamine (Drug); Morphine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Brooke Army Medical Center Official(s) and/or principal investigator(s): Joshua P Miller, MD, Principal Investigator, Affiliation: United States Air Force
Overall contact: Victoria J Ganem, BSN, Phone: 2109160808, Email: victoria.ganem@amedd.army.mil
Summary
The purpose of this study is to compare the safety and effectiveness of intravenous low dose
ketamine to the industry standard of morphine in regards to controlling acute pain in the
emergency department.
Both LDK and morphine have side effects. The amount and character of these side effects
will be compared. Additionally, the degree of sedation or agitation will be specifically
measured. The aim of this current study is to make this comparison and shift the evidence
for LDK use from the anecdotal to the scientific.
Clinical Details
Official title: Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Maximal change in NRS pain score as a percentage of initial NRS pain score
Secondary outcome: Time to change in NRS pain scoreTime to maximal change in NRS pain score Duration of maximal change in NRS pain score Incidence of treatment failure Incidence of side effects, including outlying vital signs Maximum deviation from 0 on the Richmond Agitation Sedation Scale (RASS) Nurse and physician satisfaction scores
Detailed description:
Phase 1 is a randomized, controlled, double-blinded study comparing the use of low-dose
ketamine (LDK) to morphine for acute pain control in emergency department patients. A
convenience sample of subjects will be enrolled from a population of patients aged 18-50 who
present to the Brooke Army Medical Center Emergency Department with acute abdominal pain,
flank/lumbar back pain and/or pain to the extremities. To take part in the study, a need for
opioid analgesia must be indicated by the treating physician in addition to the patient
meeting all other study criteria.
The patient will then be randomized into one of the two treatment arms. Prior to receiving
either the study medication (ketamine) or the active control (morphine) the patient will be
asked to rate their pain on a numeric rating scale (NRS) with 0 being no pain and 10 being
the worst pain possible. Their baseline vital signs (blood pressure, heart rate, respiratory
rate and oxygen saturation) will also be documented. These vital signs and the NRS will be
reassessed at 5, 10 and 20 minutes post medication dosage. At 20 minutes they will also
document a Richmond Agitation Sedation Scale (RASS) score and will ask the patient if they
require additional pain medication. If the patient denies the need for a second dose of
medication they will continue to be re-assessed every 20 minutes (vital signs, NRS, and
RASS) until either inpatient admission, discharge home, transfer to the operating room or
until a total of 120 minutes after initial dosing.
If at any time during the study the patient requires a second dose of pain medication,
following the administration of the med, they will be assessed for vital signs at 5,10 and
20 minutes after the dose. At 20 minutes, a RASS score and NRS score will also be
documented. They will then be re-assessed every 20 minutes (vital signs, NRS, and RASS)
until either inpatient admission, discharge home, transfer to the operating room or until a
total of 120 minutes after initial dosing.
If they require a third dose of pain medication at any time during the study, this is
considered a treatment failure and the treating physician will be contacted to provide any
further pain control.
The second phase of the study will be observational. An anonymous satisfaction survey will
be provided to the treating nurse, physician/PA of the patients recruited from part one of
the study. The purpose of conducting the survey is so that an observation point of view can
be added to the data to provide a measure of how well the patient's pain was controlled.
Eligibility
Minimum age: 18 Years.
Maximum age: 59 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients age 18-59 who present to the Brooke Army Medical Center Emergency Department
with acute (less than 10 days) abdominal pain, flank/lumbar back pain and or/pain to
the extremities, and of sufficient severity in the judgement of the ED treating
physician or PA to warrant use of intravenous opioids
Exclusion Criteria:
- Poor vital sign stability hypoxia: Sats<95% hypotension: SBP<90 hypertension: SBP>180
heart rate: <50 or >120 respiratory rate: <10 or >30
- Altered mental status or intoxication
- Patient is unwilling to participate or provide informed consent
- History of chronic pain or pain syndrome with concurrent opioid medication use
- fibromyalgia
- Patient has received opioids and/or tramadol in the past 4 hours
- Prescription pain medication use (to exclude muscle relaxants, acetaminophen or
NSAIDs including toradol) in the past 4 hours
- Allergy to morphine or ketamine
- Sole provider status
- Adverse reaction to morphine or ketamine in the past
- Patients, who in the opinion of the triage nurse, require immediate analgesic relief
- Patient is female of child-bearing age and unable to provide urine or serum for HCG
analysis in triage
- Pregnancy or breast feeding
- Presence of oxygen dependent pulmonary disease, liver cirrhosis or Renal disease
requiring dialysis. (as assessed by electronic chart review)
- Presence of Ischemic heart disease, heart failure or unstable dysrhythmias (as
assessed by electronic chart review)
- Presence of intracranial mass or vascular lesion.
- Presence of psychosis or hallucinations
- Weight greater than 115kg or less than 45 kg
- History of acute ocular/head trauma
- History of increased intracranial pressure/hypertensive hydrocephalus
- Non-English speaking patients
Locations and Contacts
Victoria J Ganem, BSN, Phone: 2109160808, Email: victoria.ganem@amedd.army.mil
Brooke Army Medical Center, San Antonio, Texas 78234, United States; Recruiting Victoria J Ganem, BSN, Phone: 210-916-0808, Email: victoria.ganem@amedd.army.mil Joshua P Miller, MD, Principal Investigator Steven Schauer, DO, Sub-Investigator Vikhyat Bebarta, MD, Sub-Investigator
Additional Information
Starting date: February 2012
Last updated: January 28, 2013
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