A Phase 4 interventional study of Fentanyl and Fentanyl and Ketamine in Pain, Acute, sponsored by Mercy Health Ohio. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-11.
Sponsored by Mercy Health Ohio · Phase 4, Interventional, and Treatment
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.
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.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 6 is below the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Mercy Health Ohio is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.3 mg/kg of Sub-Dissociative Ketamine IV administered over at least 1 minute
Drug: Ketamine
1 mg/kg of Fentanyl IV administered over at least 1 minute
Drug: Fentanyl
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
Combination Product: Fentanyl and Ketamine
1 mg/kg of Fentanyl IV administered over at least 1 minute
Also known as: Fentanyl Citrate
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.
0.3 mg/kg of Sub-Dissociative Ketamine IV administered over at least 1 minute
Also known as: Ketamine Hydrochloride
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
Time frame: 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
Time frame: 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
Time frame: ED encounter (less than 24 hours)
OARRS report
A retrospective review of OARRS report will be performed with each patient.
Time frame: 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
Time frame: ED encounter (less than 24 hours)
This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Mercy Health Ohio