Abdomen, AcutePhase 4NCT01538745
Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department
A Phase 4 study testing Ketamine and Morphine in people with Abdomen, Acute and Other Acute Pain, run by Brooke Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Abdomen, Acute, Other Acute Pain, Flank Pain
- What is being tested?
- Ketamine and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jun 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
San Antonio, Texas, 78234
About this study
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.
Read the 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.
- Conditions
- Abdomen, Acute, Other Acute Pain, Flank Pain, Back Pain, Musculoskeletal Pain
- Keywords
- Pain, Emergency Department, Morphine, Ketamine
- Medical subject headings
- Abdomen, Acute, Flank Pain, Back Pain, Musculoskeletal Pain, Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
0.3 mg/kg ketamine Intravenous push (IVP) over 5 minutes. Total of two possible doses.
MorphineDrug
Also called MS Contin, Roxanol, Kadian, Avinza
0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | 0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. Receives: Drug: Ketamine |
| Morphine | Active comparator | 0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5,10,20,40,60,80,100,120 minutes post dose
Secondary outcomes (5)
Time to Change in NRS Pain Score
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
Measured: 5,10, 20,40,60,80,100,120 minutes
Time to Maximal Change in NRS Pain Score
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.
Measured: 5, 10, 20 minutes and then every 20 minutes to a total of 120 minutes
Incidence of Treatment Failure
Requiring more than two doses of the study medication provided for adequate pain control
Measured: 120 minutes
Incidence of Side Effects, Including Outlying Vital Signs
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.
Measured: 5,10,20,40,60,80,100,120 minutes
Maximum Deviation From 0 on the Richmond Agitation Sedation Scale (RASS)
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
Measured: 5,10,20,40,60,80,100,120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abdomen, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- U.S. Air Force Office of the Surgeon General
- Responsible party
- Principal investigator, Joshua Miller, Brooke Army Medical Center
- Investigators
- Joshua P Miller, MD, Principal investigator, United States Air Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538745
- Sponsor's protocol ID
- C.2011.173
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2012
- Last updated
- 4 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department
- ClinicalTrials.gov ID
- NCT01538745
- Acronym / sponsor ID
- C.2011.173
- Conditions
- Abdomen, Acute, Other Acute Pain, Flank Pain, Back Pain, Musculoskeletal Pain
- Keywords
- Pain, Emergency Department, Morphine, Ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- U.S. Air Force Office of the Surgeon General
- Study start
- Feb 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Posted 4 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: Ketamine0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. |
| Morphine | Active comparator | Drug: Morphine0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: Ketalar0.3 mg/kg ketamine Intravenous push (IVP) over 5 minutes. Total of two possible doses. | Drug | Ketamine |
| MorphineAlso: MS Contin, Roxanol, Kadian, Avinza0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses. | Drug | Morphine |
Primary outcome
Maximal Change in Numerical Rating Scale (NRS) Pain Score From Baseline NRS Pain Score
Time frame: 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.
5 secondary outcomes
Time to Change in NRS Pain Score
Time frame: 5,10, 20,40,60,80,100,120 minutes
Time to Maximal Change in NRS Pain Score
Time frame: 5, 10, 20 minutes and then every 20 minutes to a total of 120 minutes
Incidence of Treatment Failure
Time frame: 120 minutes
Incidence of Side Effects, Including Outlying Vital Signs
Time frame: 5,10,20,40,60,80,100,120 minutes
Maximum Deviation From 0 on the Richmond Agitation Sedation Scale (RASS)
Time frame: 5,10,20,40,60,80,100,120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua P Miller, MD principal investigator
United States Air Force
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Morphine in people with Abdomen, Acute and Other Acute Pain, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Change in Numerical Rating Scale (NRS) Pain Score From Baseline NRS Pain Score (time frame: 5,10,20,40,60,80,100,120 minutes post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.