Pain, AcutePhase 4NCT03959852
Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain
A Phase 4 study testing Fentanyl, Fentanyl and Ketamine and Ketamine in people with Pain, Acute, run by Mercy Health Ohio at 1 site in United States.
Trial summary
The objective of this study is to evaluate the potential opioid-sparing effect associated with the novel combination of fentanyl and sub-dissociative ketamine in adult patients with moderate to severe pain in the emergency department. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Fentanyl, Fentanyl and Ketamine and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2019to 5 Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 - 65 years old
- Moderate pain defined as 4-6 out of 10, severe pain defined as ≥ 7 out of 10 as defined by the numeric rating pain scale (NRS)
- Proficient in reading and understanding English
- Are deemed by the attending physician to require opioid therapy.
Who cannot join
- Inability to give consent,
- Inability to use the numeric rating scale (NRS) score
- Long-term use of opioids, history of chronic pain
- Known substance abuse known as excessive use of a drug such as (e.g. alcohol, narcotics or cocaine)
- Known hypersensitivity to ketamine or fentanyl
- Pregnancy
Show all 21Show fewer
- Alcohol intoxication
- Depression
- Anxiety
- Chronic obstructive pulmonary disease
- Asthma
- Cirrhosis
- On dialysis
- Acute ischemic stroke
- Heart rate (HR) less < 60 bpm or > 120 bpm
- Systolic blood pressure (SBP) < 90 mmHg or > 180 mmHg
- Ischemic heart disease
- Ketamine prior to arrival
- Trauma patients
- Sepsis or septic shock
- Weight > 100 kg.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Elizabeth Boardman Hospital
Boardman, Ohio, 44512
About this study
Official title: A Combination Study With Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain in the Emergency Department
The objective of this study is to evaluate the potential opioid-sparing effect associated with the novel combination of fentanyl and sub-dissociative ketamine in adult patients with moderate to severe pain in the emergency department.
Read the detailed description
Pain is a very common complaint in the emergency department (ED). The use of opioids to treat moderate to severe pain has increased over the last decade as well as the number of opioid related deaths. In 1999 to 2016, more than 630,000 people died from a drug overdose. Treatment for acute pain has been assessed in the ED, with review of several different pain medications. Sub-dissociative ketamine (SDK) has become a valuable treatment option for acute pain and in recent years, has been of increased interest due to the growing concerns regarding opioid abuse and opioid shortage in the United States. Sub-dissociative ketamine, an NMDA receptor antagonist, has been studied in dose ranges of 1-4.5 mg/kg for dissociative sedation, as well as dose ranges of 0.1-0.3 mg/kg to treat pain. The onset of action for an IV dose of 2 mg/kg has been studied, with onset usually within 30 seconds after injection and anesthetic effect lasting 5-10 minutes. Common side effects include elevated blood pressure, diplopia or nystagmus, nausea and vomiting. More rare and more severe side effects in dissociative doses include respiratory depression, emergency phenomenon, tonic and clonic movements, and anaphylaxis. However, these were rarely, if ever seen, findings in sub-dissociative doses. Several studies indicate that SDK is a safe and effective alternative to opioids for patients with complaints of moderate to severe pain that provides adequate analgesic effect by itself. In particular, several studies have compared SDK versus morphine, particularly looking at pain in individuals with abdominal pain, flank pain, low back pain or musculoskeletal pain, and acute fractures. SDK has also shown to decrease opioid consumption and the need for rescue analgesia. The studies showed that that there was no difference in average pain scores, but the amount of morphine required was significantly decreased. SDK has proven to be a safe alternative, but the side effects, although short, make it less desirable to use. To the investigator's knowledge, there has never been a study focusing on the use of combination fentanyl and SDK. Fentanyl, an opioid agonist, has been studied in low dose forms of 2 mcg/kg for pain, moderate dose forms of 2-20 mcg/kg for major surgical procedures, and high dose forms of 20-50 mcg/kg for orthopedic and open heart surgeries. Onset of action is almost immediate when given IV, and maximal effect of the drug may take several minutes. The usual duration of action is 30-60 minutes. Common side effects include hypertension, hypotension, dizziness, blurred vision, nausea, vomiting and laryngospasm. Serious side effects included respiratory depression, apnea, rigidity, bradycardia, serotonin syndrome, adrenal insufficiency, and if left untreated could cause cardiac arrest and circulatory depression. There have been several combination studies with SDK, but none regarding fentanyl and ketamine. In one study, combination SDK and reduced dose hydromorphone produced rapid pain relief without significant side effects. Another study indicated that morphine and SDK both provided adequate pain relief alone, but combined morphine and SDK required less morphine administration, had faster onset of relief, and provided sustained reduction in pain intensity for up to 2 hours.
- Conditions
- Pain, Acute
- Keywords
- Moderate, Severe, Pain
- Medical subject headings
- Acute Pain, Lymphoma, Follicular, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Fentanyl Citrate
1 mg/kg of Fentanyl IV administered over at least 1 minute
Fentanyl and KetamineCombination product
Combined dose of 0.15 mg/kg of Sub-dissociative Ketamine and 0.5 mg/kg of Fentanyl IV administered over at least 1 minute.
KetamineDrug
Also called Ketamine Hydrochloride
0.3 mg/kg of Sub-Dissociative Ketamine IV administered over at least 1 minute
| Study group | Role | What they receive |
|---|---|---|
| Sub-Dissociative Ketamine alone | Active comparator | 0.3 mg/kg of Sub-Dissociative Ketamine IV administered over at least 1 minute Receives: Drug: Ketamine |
| Fentanyl alone | Active comparator | 1 mg/kg of Fentanyl IV administered over at least 1 minute Receives: Drug: Fentanyl |
| Sub-dissociative Ketamine and Fentanyl | Experimental | Combined dose of 0.15 mg/kg of Sub-dissociative Ketamine and 0.5 mg/kg of Fentanyl IV administered over at least 1 minute Receives: Combination Product: Fentanyl and Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia of combination fentanyl and SDK as assessed using the pain scale 1-10
Analgesia of combination fentanyl and SDK as assessed using the pain scale 1-10
Measured: ED encounter (less than 24 hours)
Analgesia of fentanyl as assessed using the pain scale 1-10
Analgesia of fentanyl as assessed using the pain scale 1-10
Measured: ED encounter (less than 24 hours)
Analgesia of ketamine as assessed using the pain scale 1-10
Analgesia of katamine as assessed using the pain scale 1-10
Measured: ED encounter (less than 24 hours)
Secondary outcomes (2)
OARRS report
A retrospective review of OARRS report will be performed with each patient.
Measured: ED encounter (less than 24 hours)
Opioid sparing response as assessed by number of times additional rescue doses of fentanyl were required
Opioid sparing response as assessed by number of times additional rescue doses of fentanyl were required
Measured: ED encounter (less than 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start18 Nov 2019
- Primary completion5 Jun 2020
- Study completion5 Jun 2020
Why it stopped: Residency completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Pain, 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Health Ohio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Gemmel, Study director, Director of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959852
- Sponsor's protocol ID
- 18-040
- Status last verified
- Sep 2020
- First submitted
- 12 Mar 2019
- Last updated
- 11 Sep 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hebsgaard S, Mannering A, Zwisler ST. Assessment of acute pain in trauma-A retrospective prehospital evaluation. J Opioid Manag. 2016 Sep/Oct;12(5):347-353. doi: 10.5055/jom.2016.0351.
PubMed 27844474Motov SM, Nelson LS. Advanced Concepts and Controversies in Emergency Department Pain Management. Anesthesiol Clin. 2016 Jun;34(2):271-85. doi: 10.1016/j.anclin.2016.01.006.
PubMed 27208710Todd KH. A Review of Current and Emerging Approaches to Pain Management in the Emergency Department. Pain Ther. 2017 Dec;6(2):193-202. doi: 10.1007/s40122-017-0090-5. Epub 2017 Nov 10.
PubMed 29127600Bowers KJ, McAllister KB, Ray M, Heitz C. Ketamine as an Adjunct to Opioids for Acute Pain in the Emergency Department: A Randomized Controlled Trial. Acad Emerg Med. 2017 Jun;24(6):676-685. doi: 10.1111/acem.13172. Epub 2017 Mar 22.
PubMed 28177167Duncan C, Riley B. BET 2: Low-dose ketamine for acute pain in the ED. Emerg Med J. 2016 Dec;33(12):892-893. doi: 10.1136/emermed-2016-206440.2.
PubMed 27864394Jennings PA, Cameron P, Bernard S, Walker T, Jolley D, Fitzgerald M, Masci K. Long-term pain prevalence and health-related quality of life outcomes for patients enrolled in a ketamine versus morphine for prehospital traumatic pain randomised controlled trial. Emerg Med J. 2014 Oct;31(10):840-3. doi: 10.1136/emermed-2013-202862. Epub 2013 Jul 13.
PubMed 23851034Lee EN, Lee JH. The Effects of Low-Dose Ketamine on Acute Pain in an Emergency Setting: A Systematic Review and Meta-Analysis. PLoS One. 2016 Oct 27;11(10):e0165461. doi: 10.1371/journal.pone.0165461. eCollection 2016.
PubMed 27788221Miller JP, Schauer SG, Ganem VJ, Bebarta VS. Low-dose ketamine vs morphine for acute pain in the ED: a randomized controlled trial. Am J Emerg Med. 2015 Mar;33(3):402-8. doi: 10.1016/j.ajem.2014.12.058. Epub 2015 Jan 7.
PubMed 25624076Motov S, Rockoff B, Cohen V, Pushkar I, Likourezos A, McKay C, Soleyman-Zomalan E, Homel P, Terentiev V, Fromm C. Intravenous Subdissociative-Dose Ketamine Versus Morphine for Analgesia in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2015 Sep;66(3):222-229.e1. doi: 10.1016/j.annemergmed.2015.03.004. Epub 2015 Mar 26.
PubMed 25817884Motov S, Rosenbaum S, Vilke GM, Nakajima Y. Is There a Role for Intravenous Subdissociative-Dose Ketamine Administered as an Adjunct to Opioids or as a Single Agent for Acute Pain Management in the Emergency Department? J Emerg Med. 2016 Dec;51(6):752-757. doi: 10.1016/j.jemermed.2016.07.087. Epub 2016 Sep 29.
PubMed 27693070Pourmand A, Mazer-Amirshahi M, Royall C, Alhawas R, Shesser R. Low dose ketamine use in the emergency department, a new direction in pain management. Am J Emerg Med. 2017 Jun;35(6):918-921. doi: 10.1016/j.ajem.2017.03.005. Epub 2017 Mar 2.
PubMed 28285863Sin B, Ternas T, Motov SM. The use of subdissociative-dose ketamine for acute pain in the emergency department. Acad Emerg Med. 2015 Mar;22(3):251-7. doi: 10.1111/acem.12604. Epub 2015 Feb 25.
PubMed 25716117Abbasi S, Bidi N, Mahshidfar B, Hafezimoghadam P, Rezai M, Mofidi M, Farsi D. Can low-dose of ketamine reduce the need for morphine in renal colic? A double-blind randomized clinical trial. Am J Emerg Med. 2018 Mar;36(3):376-379. doi: 10.1016/j.ajem.2017.08.026. Epub 2017 Aug 14.
PubMed 28821365Ahern TL, Herring AA, Miller S, Frazee BW. Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain. Pain Med. 2015 Jul;16(7):1402-9. doi: 10.1111/pme.12705. Epub 2015 Feb 3.
PubMed 25643741Dickenson AH. NMDA receptor antagonists: interactions with opioids. Acta Anaesthesiol Scand. 1997 Jan;41(1 Pt 2):112-5. doi: 10.1111/j.1399-6576.1997.tb04624.x.
PubMed 9061093
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combination Study With Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain in the Emergency Department
- ClinicalTrials.gov ID
- NCT03959852
- Acronym / sponsor ID
- 18-040
- Conditions
- Pain, Acute
- Keywords
- Moderate, Severe, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Residency completed.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mercy Health OhioUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the potential opioid-sparing effect associated with the novel combination of fentanyl and sub-dissociative ketamine in adult patients with moderate to severe pain in the emergency department.
Detailed description
Pain is a very common complaint in the emergency department (ED). The use of opioids to treat moderate to severe pain has increased over the last decade as well as the number of opioid related deaths. In 1999 to 2016, more than 630,000 people died from a drug overdose. Treatment for acute pain has been assessed in the ED, with review of several different pain medications. Sub-dissociative ketamine (SDK) has become a valuable treatment option for acute pain and in recent years, has been of increased interest due to the growing concerns regarding opioid abuse and opioid shortage in the United States. Sub-dissociative ketamine, an NMDA receptor antagonist, has been studied in dose ranges of 1-4.5 mg/kg for dissociative sedation, as well as dose ranges of 0.1-0.3 mg/kg to treat pain. The onset of action for an IV dose of 2 mg/kg has been studied, with onset usually within 30 seconds after injection and anesthetic effect lasting 5-10 minutes. Common side effects include elevated blood pressure, diplopia or nystagmus, nausea and vomiting. More rare and more severe side effects in dissociative doses include respiratory depression, emergency phenomenon, tonic and clonic movements, and anaphylaxis. However, these were rarely, if ever seen, findings in sub-dissociative doses. Several studies indicate that SDK is a safe and effective alternative to opioids for patients with complaints of moderate to severe pain that provides adequate analgesic effect by itself. In particular, several studies have compared SDK versus morphine, particularly looking at pain in individuals with abdominal pain, flank pain, low back pain or musculoskeletal pain, and acute fractures. SDK has also shown to decrease opioid consumption and the need for rescue analgesia. The studies showed that that there was no difference in average pain scores, but the amount of morphine required was significantly decreased. SDK has proven to be a safe alternative, but the side effects, although short, make it less desirable to use. To the investigator's knowledge, there has never been a study focusing on the use of combination fentanyl and SDK. Fentanyl, an opioid agonist, has been studied in low dose forms of 2 mcg/kg for pain, moderate dose forms of 2-20 mcg/kg for major surgical procedures, and high dose forms of 20-50 mcg/kg for orthopedic and open heart surgeries. Onset of action is almost immediate when given IV, and maximal effect of the drug may take several minutes. The usual duration of action is 30-60 minutes. Common side effects include hypertension, hypotension, dizziness, blurred vision, nausea, vomiting and laryngospasm. Serious side effects included respiratory depression, apnea, rigidity, bradycardia, serotonin syndrome, adrenal insufficiency, and if left untreated could cause cardiac arrest and circulatory depression. There have been several combination studies with SDK, but none regarding fentanyl and ketamine. In one study, combination SDK and reduced dose hydromorphone produced rapid pain relief without significant side effects. Another study indicated that morphine and SDK both provided adequate pain relief alone, but combined morphine and SDK required less morphine administration, had faster onset of relief, and provided sustained reduction in pain intensity for up to 2 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sub-Dissociative Ketamine alone | Active comparator | Drug: Ketamine0.3 mg/kg of Sub-Dissociative Ketamine IV administered over at least 1 minute |
| Fentanyl alone | Active comparator | Drug: Fentanyl1 mg/kg of Fentanyl IV administered over at least 1 minute |
| Sub-dissociative Ketamine and Fentanyl | Experimental | Combination Product: Fentanyl and KetamineCombined dose of 0.15 mg/kg of Sub-dissociative Ketamine and 0.5 mg/kg of Fentanyl IV administered over at least 1 minute |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 65 years old
- Moderate pain defined as 4-6 out of 10, severe pain defined as ≥ 7 out of 10 as defined by the numeric rating pain scale (NRS)
- Proficient in reading and understanding English
- Are deemed by the attending physician to require opioid therapy.
Key exclusion criteria (21 listed)
- Inability to give consent,
- Inability to use the numeric rating scale (NRS) score
- Long-term use of opioids, history of chronic pain
- Known substance abuse known as excessive use of a drug such as (e.g. alcohol, narcotics or cocaine)
- Known hypersensitivity to ketamine or fentanyl
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 |
|---|---|---|
| FentanylAlso: Fentanyl Citrate1 mg/kg of Fentanyl IV administered over at least 1 minute | Drug | Fentanyl alone |
| Fentanyl and KetamineCombined dose of 0.15 mg/kg of Sub-dissociative Ketamine and 0.5 mg/kg of Fentanyl IV administered over at least 1 minute. | Combination product | Sub-dissociative Ketamine and Fentanyl |
| KetamineAlso: Ketamine Hydrochloride0.3 mg/kg of Sub-Dissociative Ketamine IV administered over at least 1 minute | Drug | Sub-Dissociative Ketamine alone |
Primary outcome
Analgesia of combination fentanyl and SDK as assessed using the pain scale 1-10
Time frame: ED encounter (less than 24 hours)
Analgesia of combination fentanyl and SDK as assessed using the pain scale 1-10
Analgesia of fentanyl as assessed using the pain scale 1-10
Time frame: ED encounter (less than 24 hours)
Analgesia of fentanyl as assessed using the pain scale 1-10
Analgesia of ketamine as assessed using the pain scale 1-10
Time frame: ED encounter (less than 24 hours)
Analgesia of katamine as assessed using the pain scale 1-10
2 secondary outcomes
OARRS report
Time frame: ED encounter (less than 24 hours)
Opioid sparing response as assessed by number of times additional rescue doses of fentanyl were required
Time frame: ED encounter (less than 24 hours)
Results and safety
The study was stopped early (reason given: Residency completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Background: PubMed 27844474Hebsgaard S, Mannering A, Zwisler ST. Assessment of acute pain in trauma-A retrospective prehospital evaluation. J Opioid Manag. 2016 Sep/Oct;12(5):347-353. doi: 10.5055/jom.2016.0351.
- Background: PubMed 27208710Motov SM, Nelson LS. Advanced Concepts and Controversies in Emergency Department Pain Management. Anesthesiol Clin. 2016 Jun;34(2):271-85. doi: 10.1016/j.anclin.2016.01.006.
- Background: PubMed 29127600Todd KH. A Review of Current and Emerging Approaches to Pain Management in the Emergency Department. Pain Ther. 2017 Dec;6(2):193-202. doi: 10.1007/s40122-017-0090-5. Epub 2017 Nov 10.
- Background: PubMed 28177167Bowers KJ, McAllister KB, Ray M, Heitz C. Ketamine as an Adjunct to Opioids for Acute Pain in the Emergency Department: A Randomized Controlled Trial. Acad Emerg Med. 2017 Jun;24(6):676-685. doi: 10.1111/acem.13172. Epub 2017 Mar 22.
- Background: PubMed 27864394Duncan C, Riley B. BET 2: Low-dose ketamine for acute pain in the ED. Emerg Med J. 2016 Dec;33(12):892-893. doi: 10.1136/emermed-2016-206440.2.
- Background: PubMed 23851034Jennings PA, Cameron P, Bernard S, Walker T, Jolley D, Fitzgerald M, Masci K. Long-term pain prevalence and health-related quality of life outcomes for patients enrolled in a ketamine versus morphine for prehospital traumatic pain randomised controlled trial. Emerg Med J. 2014 Oct;31(10):840-3. doi: 10.1136/emermed-2013-202862. Epub 2013 Jul 13.
- Background: PubMed 27788221Lee EN, Lee JH. The Effects of Low-Dose Ketamine on Acute Pain in an Emergency Setting: A Systematic Review and Meta-Analysis. PLoS One. 2016 Oct 27;11(10):e0165461. doi: 10.1371/journal.pone.0165461. eCollection 2016.
- Background: PubMed 25624076Miller JP, Schauer SG, Ganem VJ, Bebarta VS. Low-dose ketamine vs morphine for acute pain in the ED: a randomized controlled trial. Am J Emerg Med. 2015 Mar;33(3):402-8. doi: 10.1016/j.ajem.2014.12.058. Epub 2015 Jan 7.
- Background: PubMed 25817884Motov S, Rockoff B, Cohen V, Pushkar I, Likourezos A, McKay C, Soleyman-Zomalan E, Homel P, Terentiev V, Fromm C. Intravenous Subdissociative-Dose Ketamine Versus Morphine for Analgesia in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2015 Sep;66(3):222-229.e1. doi: 10.1016/j.annemergmed.2015.03.004. Epub 2015 Mar 26.
- Background: PubMed 27693070Motov S, Rosenbaum S, Vilke GM, Nakajima Y. Is There a Role for Intravenous Subdissociative-Dose Ketamine Administered as an Adjunct to Opioids or as a Single Agent for Acute Pain Management in the Emergency Department? J Emerg Med. 2016 Dec;51(6):752-757. doi: 10.1016/j.jemermed.2016.07.087. Epub 2016 Sep 29.
- Background: PubMed 28285863Pourmand A, Mazer-Amirshahi M, Royall C, Alhawas R, Shesser R. Low dose ketamine use in the emergency department, a new direction in pain management. Am J Emerg Med. 2017 Jun;35(6):918-921. doi: 10.1016/j.ajem.2017.03.005. Epub 2017 Mar 2.
- Background: PubMed 25716117Sin B, Ternas T, Motov SM. The use of subdissociative-dose ketamine for acute pain in the emergency department. Acad Emerg Med. 2015 Mar;22(3):251-7. doi: 10.1111/acem.12604. Epub 2015 Feb 25.
- U.S. Department of Health and Human Services. (2018, October 15). U.S. Food and Drug Administration. Retrieved October 15, 2018, from https://www.accessdata.fda.gov/scripts/drugshortages/Link provided by the sponsor.
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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.
David Gemmel study director
Director of Research
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 Fentanyl, Fentanyl and Ketamine and Ketamine in people with Pain, Acute, run by Mercy Health Ohio 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 4 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: stopped early, as of the sponsor's last update on 11 Sep 2020. 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?
The study was stopped early (reason given: Residency completed.). Results are not available in the source record.
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?
Analgesia of combination fentanyl and SDK as assessed using the pain scale 1-10 (time frame: ED encounter (less than 24 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03959852, which also lists 24 linked publications.
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 11 Sep 2020.