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

Phase 4

Completed

Conditions: Abdomen, Acute
Other Acute Pain
Back Pain
Musculoskeletal Pain
Flank Pain

Interventions: Drug: Ketamine
Drug: Morphine

Registration Number: NCT01538745

Lead Sponsor: Brooke Army Medical Center

Brief Summary: The purpose of this study is to compare the safety and effectiveness of intravenous low dose ketamine (LDK) to the industry standard of morphine (MOR) 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.

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 or physicians assistant (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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 45

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG.
Morphine	Morphine	0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG.

Primary Outcome Measures

Name	Time	Method
Maximal Change in Numerical Rating Scale (NRS) Pain Score From Baseline NRS Pain Score	5,10,20,40,60,80,100,120 minutes post dose	Numerical Rating Scale (NRS) pain score is an 11-point rating scale for pain. With 0 being no pain and 10 being the worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Time to Change in NRS Pain Score	5,10, 20,40,60,80,100,120 minutes	Following dosage with study medication, the amount of time taken to demonstrate a change in the patient's NRS pain score. Time to Change in NRS Pain Score for the Reporting Group as a whole will be made
Incidence of Side Effects, Including Outlying Vital Signs	5,10,20,40,60,80,100,120 minutes	The patient will be assessed for vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation), and all side effects 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.
Time to Maximal Change in NRS Pain Score	5, 10, 20 minutes and then every 20 minutes to a total of 120 minutes	Following dosage with study medication, the interval time taken to demonstrate the maximal change in the patient's NRS pain score will be reported for each group.
Incidence of Treatment Failure	120 minutes	Requiring more than two doses of the study medication provided for adequate pain control
Maximum Deviation From 0 on the Richmond Agitation Sedation Scale (RASS)	5,10,20,40,60,80,100,120 minutes	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. Results will be reported as Richmond Agitation Sedation Scale (RASS) scores range from: * 4 Combative: Overtly combative, violent, immediate danger to staff * 3 Very agitated: Pulls or removes tube(s) or catheter(s); aggressive * 2 Agitated: Frequent non-purposeful movement * 1 Restless: Anxious but movements not aggressive. vigorous 0 Alert and calm * 1 Drowsy: Not fully alert, but has sustained awakening (eye-opening/eye contact) to voice (\>10 seconds) * 2 Light sedation: Briefly awakens with eye contact to voice (\<10 seconds) * 3 Moderate sedation: Movement or eye opening to voice (but no eye contact) * 4 Deep sedation: No response to voice, but movement or eye opening to physical stimulation * 5 Unarousable: No response to voice or physical stimulation