Acute PainPhase 4NCT03714620
Sub-dissociative Dose Ketamine Dosing Study
A Phase 4 study testing Ketamine in people with Acute Pain, run by Loyola University at 1 site in United States.
Trial summary
Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to Ketamine administered at 0.3 mg/kg, with fewer adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 17 Sep 2019
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults ages 18-59
- Weight 45 - 115 kg
- Acute abdominal, flank, back, musculoskeletal pain, or a headache
- Onset of pain within 7 days
- Pain score of 5 or more
- Requiring intravenous analgesia
- Hasn't been enrolled in this study previously
Who cannot join
- Pregnancy
- Breast-feeding
- Altered mental status rendering the patient unable to consent to the study
- Allergy to ketamine
- Unstable vital signs (systolic blood pressure <90 or >180 mm Hg, pulse rate <50 or >150 beats/minute, and respiration rate <10 or >30 breaths/minute)
- History of acute head or eye injury, seizure, intracranial hypertension
Show all 11Show fewer
- Chronic pain
- Renal or hepatic insufficiency
- Known alcohol or drug use disorder
- Currently under influence of alcohol/opiates
- Acute psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department
Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to Ketamine administered at 0.3 mg/kg, with fewer adverse effects.
Read the detailed description
Study investigators will enroll participants who present to the Emergency Department (ED) with moderate to severe acute pain, and require intravenous pain medication. Participants will be double-blinded and randomized to one of the two treatment groups.
Investigators aim to determine if ketamine 0.15 mg/kg IVPB is non-inferior to ketamine 0.3 mg/kg IVBP for the treatment of acute moderate to severe pain in the Emergency Department (ED). Study investigators hypothesize that in adults presenting to the ED with moderate to severe acute pain, SDK administered at 0.15 mg/kg will provide similar pain relief to SDK at 0.3 mg/kg, with reduced adverse effects.
- Conditions
- Acute Pain
- Being tested
- Ketamine
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| 0.15 mg/kg IV Ketamine | Active comparator | Not described Receives: Drug: Ketamine |
| 0.3 mg/kg IV Ketamine | Active comparator | Not described Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration
Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
Measured: 30 minutes
Secondary outcomes (5)
Change in Pain Score From Baseline to 15 Minutes
Change in numerical pain score (NRS) from time 0 to time 15 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
Measured: 15 minutes
Change in Pain Score From Baseline to 60 Minutes
Change in numerical pain score (NRS) from time 0 to time 60 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
Measured: 60 minutes
Number of Participants Who Need Additional Pain Medication at 30 Minutes
Patient request for additional pain medications at 30 minutes post initiation of drug administration
Measured: 30 minutes
Number of Patients Who Need Rescue Medications at 60 Minutes
Patient request for additional pain medications at 60 minutes
Measured: 60 minutes
Adverse Effects at 30 Min
Patients were asked if they had any adverse effects at 30 minutes including nausea, dizziness, headache, hallucinations, etc.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start15 Oct 2018
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
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 Acute PainStudies 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
- Model description
- The sequence will be generated using randomization permuted blocks of 2 and 4 patients, with the allocated dose revealed using an online randomization module within the REDCap data management system.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Lovett, Loyola University
- Investigators
- Shannon Lovett, MD, Principal investigator, Loyola University Chicago, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714620
- Sponsor's protocol ID
- 211328
- Status last verified
- Aug 2022
- First submitted
- 17 Oct 2018
- Last updated
- 9 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Intravenous Sub-dissociative Ketamine at Two Doses for Analgesia in the Emergency Department
- ClinicalTrials.gov ID
- NCT03714620
- Acronym / sponsor ID
- 211328
- Conditions
- Acute Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Posted 9 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to Ketamine administered at 0.3 mg/kg, with fewer adverse effects.
Detailed description
Study investigators will enroll participants who present to the Emergency Department (ED) with moderate to severe acute pain, and require intravenous pain medication. Participants will be double-blinded and randomized to one of the two treatment groups.
Investigators aim to determine if ketamine 0.15 mg/kg IVPB is non-inferior to ketamine 0.3 mg/kg IVBP for the treatment of acute moderate to severe pain in the Emergency Department (ED). Study investigators hypothesize that in adults presenting to the ED with moderate to severe acute pain, SDK administered at 0.15 mg/kg will provide similar pain relief to SDK at 0.3 mg/kg, with reduced adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The sequence will be generated using randomization permuted blocks of 2 and 4 patients, with the allocated dose revealed using an online randomization module within the REDCap data management system.
| Arm | Type | Receives |
|---|---|---|
| 0.15 mg/kg IV Ketamine | Active comparator | Drug: Ketamine |
| 0.3 mg/kg IV Ketamine | Active comparator | Drug: Ketamine |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults ages 18-59
- Weight 45 - 115 kg
- Acute abdominal, flank, back, musculoskeletal pain, or a headache
- Onset of pain within 7 days
- Pain score of 5 or more
Key exclusion criteria (11 listed)
- Pregnancy
- Breast-feeding
- Altered mental status rendering the patient unable to consent to the study
- Allergy to ketamine
- Unstable vital signs (systolic blood pressure <90 or >180 mm Hg, pulse rate <50 or >150 beats/minute, and respiration rate <10 or >30 breaths/minute)
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 |
|---|---|---|
| KetamineKetamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes | Drug | 0.15 mg/kg IV Ketamine, 0.3 mg/kg IV Ketamine |
Primary outcome
Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration
Time frame: 30 minutes
Change in numerical pain score (NRS) from time 0 to time 30 min. The NRS ranges from 0 to 10 with higher scores indicating more pain.
5 secondary outcomes
Change in Pain Score From Baseline to 15 Minutes
Time frame: 15 minutes
Change in Pain Score From Baseline to 60 Minutes
Time frame: 60 minutes
Number of Participants Who Need Additional Pain Medication at 30 Minutes
Time frame: 30 minutes
Number of Patients Who Need Rescue Medications at 60 Minutes
Time frame: 60 minutes
Adverse Effects at 30 Min
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Acute Pain
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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.
Shannon Lovett, MD principal investigator
Loyola University Chicago, LUMC
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 in people with Acute Pain, run by Loyola University 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 7 inclusion and 11 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 9 Aug 2022. 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 9 Aug 2022). 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?
Change in Pain Score From Baseline to 30 Minutes Post Initiation of Drug Administration (time frame: 30 minutes). 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 9 Aug 2022.