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

NCT01538745 | Completed Phase 4 Results DMC

• 1 other identifier: C.2011.173
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdomen, Acute; Other Acute Pain; Flank Pain; Back Pain; Musculoskeletal Pain

Keywords

Pain; Emergency Department; Morphine; Ketamine

Outcome Measures

Primary Outcomes (1)

• Maximal Change in Numerical Rating Scale (NRS) Pain Score From Baseline NRS Pain Score

  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.

  5,10,20,40,60,80,100,120 minutes post dose

Secondary Outcomes (5)

• Time to Change in NRS Pain Score

  5,10, 20,40,60,80,100,120 minutes

• Time to Maximal Change in NRS Pain Score

  5, 10, 20 minutes and then every 20 minutes to a total of 120 minutes

• Incidence of Treatment Failure

  120 minutes

• Incidence of Side Effects, Including Outlying Vital Signs

  5,10,20,40,60,80,100,120 minutes

• Maximum Deviation From 0 on the Richmond Agitation Sedation Scale (RASS)

  5,10,20,40,60,80,100,120 minutes

Study Arms (2)

Ketamine

EXPERIMENTAL

0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG.

Drug: Ketamine

Morphine

ACTIVE COMPARATOR

0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG.

Drug: Morphine

Interventions

Ketamine DRUG

0.3 mg/kg ketamine Intravenous push (IVP) over 5 minutes. Total of two possible doses.

Also known as: Ketalar

Ketamine

Morphine DRUG

0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.

Also known as: MS Contin, Roxanol, Kadian, Avinza

Morphine

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• U.S. Air Force Office of the Surgeon General: collaborator

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

MeSH Terms

Conditions

Abdomen, Acute; Flank Pain; Back Pain; Musculoskeletal Pain; Pain; Emergencies

Interventions

Ketamine; Morphine

Condition Hierarchy (Ancestors)

Abdominal Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Muscular Diseases; Musculoskeletal Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

The side effect profile associated with ketamine and morphine are different without significant overlap thus making blinding difficult. The exclusion criteria of our study made enrollment difficult and our sample size smaller than anticipated.

Results Point of Contact

• Title: Josh Miller
• Organization: SAUSHEC

joshmillersr@gmail.com

210-916-7111

Study Officials

• Joshua P Miller, MD

  United States Air Force

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joshua Miller, Maj, USAF, MC

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: February 24, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 4, 2021
• Results First Posted: February 4, 2021

Record last verified: 2021-02

Locations

US (1)