Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain
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ClinicalTrials.gov Identifier: NCT03959852 |
Recruitment Status :
Terminated
(Residency completed.)
First Posted : May 22, 2019
Last Update Posted : September 11, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain, Acute | Drug: Fentanyl Combination Product: Fentanyl and Ketamine Drug: Ketamine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Combination Study With Sub-Dissociative Ketamine and Fentanyl to Treat Moderate to Severe Pain in the Emergency Department |
Actual Study Start Date : | November 18, 2019 |
Actual Primary Completion Date : | June 5, 2020 |
Actual Study Completion Date : | June 5, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Sub-Dissociative Ketamine alone
0.3 mg/kg of Sub-Dissociative Ketamine IV administered over at least 1 minute
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Drug: Ketamine
0.3 mg/kg of Sub-Dissociative Ketamine IV administered over at least 1 minute
Other Name: Ketamine Hydrochloride |
Active Comparator: Fentanyl alone
1 mg/kg of Fentanyl IV administered over at least 1 minute
|
Drug: Fentanyl
1 mg/kg of Fentanyl IV administered over at least 1 minute
Other Name: Fentanyl Citrate |
Experimental: Sub-dissociative Ketamine and 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
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Combination Product: Fentanyl and Ketamine
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. |
- 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
- OARRS report [ Time Frame: ED encounter (less than 24 hours) ]A retrospective review of OARRS report will be performed with each patient.
- Opioid sparing response as assessed by number of times additional rescue doses of fentanyl were required [ Time Frame: ED encounter (less than 24 hours) ]Opioid sparing response as assessed by number of times additional rescue doses of fentanyl were required

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959852
United States, Ohio | |
St. Elizabeth Boardman Hospital | |
Boardman, Ohio, United States, 44512 |
Study Director: | David Gemmel | Director of Research |
Publications:
Responsible Party: | Mercy Health Ohio |
ClinicalTrials.gov Identifier: | NCT03959852 |
Other Study ID Numbers: |
18-040 |
First Posted: | May 22, 2019 Key Record Dates |
Last Update Posted: | September 11, 2020 |
Last Verified: | September 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Moderate Severe Pain |
Acute Pain Pain Neurologic Manifestations Fentanyl Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, Intravenous |
Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Narcotics Adjuvants, Anesthesia |