Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Brooke Army Medical Center
Sponsor:
Collaborator:
U.S. Air Force Office of the Surgeon General
Information provided by (Responsible Party):
Joshua Miller, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT01538745
First received: February 21, 2012
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Abdomen, Acute
Other Acute Pain
Flank Pain, Acute
Back Pain, Acute
Extremity Pain, Acute
Drug: Ketamine
Drug: Morphine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • Maximal change in NRS pain score as a percentage of initial NRS pain score [ Time Frame: 20,40,60,80,100,120 minutes post dose ] [ Designated as safety issue: No ]
    Evaluation of the maximal change in patient's pain (based on their numerical rating scale score) throughout the study versus their initial pain rating prior to drug administration.


Secondary Outcome Measures:
  • Time to change in NRS pain score [ Time Frame: 20,40,60,80,100,120 minutes ] [ Designated as safety issue: No ]
    Following dosage with study medication, the amount of time in increments of 20 minutes taken to demonstrate a change in the patient's NRS pain score.

  • Time to maximal change in NRS pain score [ Time Frame: every 20 minutes to a total of 120 minutes ] [ Designated as safety issue: No ]
    Following dosage with study medication, the amount of time in increments of 20 minutes taken to demonstrate the maximal change in the patient's NRS pain score.

  • Duration of maximal change in NRS pain score [ Time Frame: 20,40,60,80,100,120 minutes ] [ Designated as safety issue: No ]
    Maximal change in NRS pain score is to be defined as the largest change from patient's baseline pain score. Duration of maximal change is how long the patient's pain score remained at this level.

  • Incidence of treatment failure [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    Requiring more than two doses of the study medication provided for adequate pain control

  • Incidence of side effects, including outlying vital signs [ Time Frame: 20,40,60,80,100,120 minutes ] [ Designated as safety issue: No ]
    The patient will be assessed for vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation), Numerical Rating Score (NRS) and Richmond Agitation Sedation Scale (RASS) score at 5,10,20 minutes following medication administration and then every 20 minutes until a total of 120 minutes from the first dose of study medication. All side effects and outlying vital signs will be documented.

  • Maximum deviation from 0 on the Richmond Agitation Sedation Scale (RASS) [ Time Frame: 20,40,60,80,100,120 minutes ] [ Designated as safety issue: No ]
    Using 0 as the "normal/baseline" on the RASS, maximal deviation in either direction will be used to demonstrate the effect of the study medications on levels of sedation or agitation.

  • Nurse and physician satisfaction scores [ Time Frame: 120 minutes after start of study ] [ Designated as safety issue: No ]
    The patient's treating nurses and physicians/PAs will be given a survey to evaluate the level of pain control they believe the patient achieved.


Estimated Enrollment: 210
Study Start Date: February 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine
0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG.
Drug: Ketamine
0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses.
Other Name: Ketalar
Active Comparator: Morphine
0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG.
Drug: Morphine
0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
Other Names:
  • MS Contin
  • Roxanol
  • Kadian
  • Avinza

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

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538745

Contacts
Contact: Victoria J Ganem, BSN 2109160808 victoria.ganem@amedd.army.mil

Locations
United States, Texas
Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78234
Contact: Victoria J Ganem, BSN    210-916-0808    victoria.ganem@amedd.army.mil   
Principal Investigator: Joshua P Miller, MD         
Sub-Investigator: Steven Schauer, DO         
Sub-Investigator: Vikhyat Bebarta, MD         
Sponsors and Collaborators
Brooke Army Medical Center
U.S. Air Force Office of the Surgeon General
Investigators
Principal Investigator: Joshua P Miller, MD United States Air Force
  More Information

No publications provided

Responsible Party: Joshua Miller, Joshua Miller, Capt, USAF, MC, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT01538745     History of Changes
Other Study ID Numbers: C.2011.173
Study First Received: February 21, 2012
Last Updated: January 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Brooke Army Medical Center:
Pain
Emergency Department
Morphine
Ketamine

Additional relevant MeSH terms:
Back Pain
Flank Pain
Acute Pain
Abdominal Pain
Pain
Abdomen, Acute
Emergencies
Signs and Symptoms
Signs and Symptoms, Digestive
Neurologic Manifestations
Nervous System Diseases
Disease Attributes
Pathologic Processes
Ketamine
Morphine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 28, 2014