Ketamine for Pain in the Emergency Department
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| ClinicalTrials.gov Identifier: NCT03896230 |
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Recruitment Status :
Recruiting
First Posted : March 29, 2019
Last Update Posted : May 7, 2019
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Sponsor:
Hackensack Meridian Health
Information provided by (Responsible Party):
Hackensack Meridian Health
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Brief Summary:
This study will prospectively compare the mean Numerical Rating Scale (NRS) pain score reduction amongst three recommended dosing strategies of intravenous ketamine (0.1 mg/kg, 0.2 mg/kg, and 0.3mg/kg) for acute pain in the emergency department (ED).This study will also examine the frequency of adverse events secondary to ketamine including fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing or vision, mood changes, generalized discomfort, and hallucinations, changes in vital signs. Subgroups for exploratory analysis based on the need for rescue analgesia within two hours of ketamine administration, adequate pain relief, previous opioid tolerance, and age (adults < 65 years old and > 65 years old).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Pain | Drug: Ketamine Injectable Product | Phase 4 |
A literature review was performed that searched for randomized clinical trials involving ketamine IV boluses for acute pain in the Emergency Department. Studies involving continuous infusions or intranasal routes of ketamine administration were not included. Thirteen randomized clinical trials were identified meeting this criteria. None of these trials directly compared ketamine doses within the 0.1-0.3 mg/kg range for pain score reduction and adverse events. Many of these trials concluded with the recommendation that further studies were needed to evaluate the optimal dosing of ketamine for acute pain and determine which populations are most ideal for its use. This study will be the first to evaluate ketamine for acute pain in the emergency department at standard of care doses (0.1 mg/kg, 0.2 mg/kg, and 0.3 mg/kg IV) to determine which dose correlates with the most efficacy and safety.
This study will include the following procedures:
- Patient consent, screening, and enrollment will be performed by the treating resident or attending who will remain blinded
- Patient will be assigned a subject number
- Treating resident or attending will notify the ED pharmacist that a patient has been enrolled in the trial
- ED pharmacist will notify the IV room and place the study drug order
- Either the ED pharmacist or a pharmacy supervisor will randomize the subject based on the predetermined randomization list
- Study drug will be prepared as 0.1 mg/kg, 0.2 mg/kg, or 0.3 mg/kg IV dose in a 100 mL solution of dextrose 5% or sodium chloride 0.9%
- ED pharmacist will promptly deliver the study drug to the ED
- Baseline vital signs will be assessed prior to starting the study drug infusion
- Study drug will be administered via IV infusion over 20 minutes
- Treating resident or attending will reassess the patient at 15 minutes from the end of infusion, at 30 minutes from the end of infusion, and then every 30 minutes for up to 120 minutes or until discharge, whichever is sooner
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 3 arms each arm getting a different dose of ketamine |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Double-blinded study (only the pharmacist supervisor that has no other involvement with the study will know the dose) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison of Ketamine 0.1 mg/kg, 0.2 mg/kg, and 0.3 mg/kg Intravenous Doses for Acute Pain in the Emergency Department: A Prospective, Randomized, Double-blind, Active-controlled, Clinical Trial |
| Actual Study Start Date : | May 3, 2019 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | December 2020 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Ketamine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Arm 1: 0.1 mg/kg ketamine
0.1 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
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Drug: Ketamine Injectable Product
Three different doses of ketamine will be administered. |
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Active Comparator: Arm 1: 0.2 mg/kg ketamine
0.2 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
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Drug: Ketamine Injectable Product
Three different doses of ketamine will be administered. |
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Active Comparator: Arm 1: 0.3 mg/kg ketamine
0.3 mg/kg in a 100 mL solution of dextrose 5% or sodium chloride 0.9% will be give after patient consent and enrollment in the study, vitals are followed (heart rate, systolic blood pressure and respiratory rate) for 2 hours following completion of ketamine infusion. Evaluated for side effects for 2 hours following completion of ketamine infusion.
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Drug: Ketamine Injectable Product
Three different doses of ketamine will be administered. |
Primary Outcome Measures :
- Pain score [ Time Frame: 2 hours post infusion completion ]Pain score using Numerical Rating Scale (NRS) post ketamine infusion. The Numerical Rating Scale (NRS) ranges from 0-to-10 with 0 being no pain and lower numbers representing less pain, so in this case lower numbers will represent better outcomes.
Secondary Outcome Measures :
- Adverse Events [ Time Frame: 2 hours post infusion completion ]Frequency of adverse events secondary to ketamine including fatigue, dizziness, nausea, headache, feeling of unreality, changes in hearing or vision, mood changes, generalized discomfort, and hallucinations, changes in vital signs.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Acute pain (including acute on chronic pain)
- Pain score of moderate to severe (> 4/10) on the Numerical Rating Scale
- Provider determines the patient requires intravenous ketamine for analgesia
Exclusion Criteria:
- History of hypersensitivity to ketamine
- Altered mental status
- Psychiatric illness
- Known history of renal or hepatic insufficiency
- Acute head or eye injury
- Suspected intracranial hypertension or mass
- Headache as the chief complaint
- Alcohol or drug abuse
- Received an analgesic within the last four hours
- History of congestive heart failure
- History of aortic or brain aneurysm
- Active Chest Pain
- Porphyria
- Active methadone treatment
- Pregnant or breastfeeding
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Signs of respiratory, hemodynamic, or neurologic compromise
- Systolic blood pressure < 90 mmHg or > 180 mmHg
- Heart rate < 50 beats per minute or > 150 beats per minute
- Respiratory rate < 10 breaths per minute or > 30 breaths per minute
- Glasgow Coma Score < 15
- Previously received ketamine < 0.3 mg/kg IV for acute pain in the emergency department
Information from the National Library of Medicine
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): NCT03896230
Contacts
| Contact: Gabrielle Procopio, PharmD | 5519964368 | Gabrielle.Procopio@hackensackmeridian.org | |
| Contact: David Zodda, MD | 5519963636 | David.Zodda@hackensackmeridian.org |
Locations
| United States, New Jersey | |
| Hackensack University Medical Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Gabrielle Procopio, PharmD | |
| Principal Investigator: Gabrielle Procopio, PharmD | |
Sponsors and Collaborators
Hackensack Meridian Health
Publications:
2. American College of Emergency Physicians Policy Statement. Optimizing the treatment of acute pain in the emergency department. Ann Emerg Med. 2017;70:446-8.
4. Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. Highlights of the 2011 Drug Abuse Warning Network (DAWN) findings on drug-related emergency department visits. 2013. Rockville, MD.
12. American College of Emergency Physicians. "Sub-Dissociative Ketamine for Analgesia". Policy Resource and Education Paper. November 2017.
24. Ketalar [package insert]. Chestnut Ridge, NY. Par Pharmaceutical.
25. Food and Drug Administration (FDA). Extended-release (ER) and long-acting (LA) opioid analgesics Risk Evaluation and Mitigation Strategy (REMS). www.fda.gov/downloads/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm311290.pdf. Accessed September 20th, 2018.
| Responsible Party: | Hackensack Meridian Health |
| ClinicalTrials.gov Identifier: | NCT03896230 History of Changes |
| Other Study ID Numbers: |
Pro2018-0970 |
| First Posted: | March 29, 2019 Key Record Dates |
| Last Update Posted: | May 7, 2019 |
| Last Verified: | May 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | All study related materials will be kept confidential as required by law. Written documentation and computer files will remain in a locked or password protected location, with access given to those directly responsible for the conduct of the study. In addition, all information will be recorded in such a manner that subjects whose data is included in the analysis cannot be identified directly or through identifiers linked to the subjects. |
| 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 |
Keywords provided by Hackensack Meridian Health:
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moderate to severe pain emergency department patient ketamine |
Additional relevant MeSH terms:
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Emergencies Acute Pain Disease Attributes Pathologic Processes Pain Neurologic Manifestations Signs and Symptoms 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 |