Clinical trial · Interventional
Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain
A Combination Study With Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain in the Emergency Department
NCT03959852CI-TRIAL-00047119terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Residency completed.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain, Acute | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl | Drug | — | UNRESOLVED |
| Fentanyl and Ketamine | Combination Product | — | UNRESOLVED |
| Ketamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Sub-Dissociative Ketamine alone
- description
- 0.3 mg/kg of Sub-Dissociative Ketamine IV administered over at least 1 minute
- interventionNames
- Drug: Ketamine
- type
- ACTIVE_COMPARATOR
- label
- Fentanyl alone
- description
- 1 mg/kg of Fentanyl IV administered over at least 1 minute
- interventionNames
- Drug: Fentanyl
- type
- EXPERIMENTAL
- label
- Sub-dissociative Ketamine and Fentanyl
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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.
References
Publications (24)
- BACKGROUNDHebsgaard 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. PMID 27844474
- BACKGROUNDMotov 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. PMID 27208710
- BACKGROUNDTodd 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. PMID 29127600
- BACKGROUNDBowers 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. PMID 28177167
- BACKGROUNDDuncan 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. PMID 27864394
- BACKGROUNDJennings 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. PMID 23851034
- BACKGROUNDLee 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. PMID 27788221
- Miller 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.