Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients

NCT02432456 | Completed Phase 4 Results

• 1 other identifier: PRO00024679
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of ketamine infusions in the management of acute pain resulting from broken ribs suffered following a blunt trauma. Half of patients will receive the institutional standard of care and a placebo infusion (no active medication). The other half of patients will receive the institutional standard of care and a ketamine infusion. All subjects and staff will be blinded as to whether they are receiving placebo or ketamine.

Conditions

Wounds and Injuries; Rib Fractures

Outcome Measures

Primary Outcomes (1)

• Visual Analog Numeric Pain Score

  Visual Analog Numeric Pain scores are reported as a single numeric score between 0 and 10. The more severe the pain the higher the number with 10 representing the most severe pain imaginable.

  12-24 hours post infusion

Secondary Outcomes (8)

• Visual Analog Numeric Pain Score

  24-48 hours post infusion

• Oral Morphine Equivalent (Narcotic Usage)

  12-24 hours post infusion

• Oral Morphine Equivalent (Narcotic Usage)

  24-48 hours post infusion

• Length of Stay

  Total Index Hospitalization up to 365 days

• Regional Anesthesia Utilization

  Total Index Hospitalization up to 365 days

Study Arms (2)

Placebo Infusion

PLACEBO COMPARATOR

Subjects in this arm will receive the institutional standard of care for rib fractures along with a placebo (NaCl) infusion. All patients will undergo Intercostal Nerve Blockade with administration of scheduled medications including acetaminophen, ibuprofen, pantoprazole, and methocarbamol. All subjects will receive adjunct opioids.

Drug: Placebo; Procedure: Intercostal Nerve Block; Drug: Acetaminophen; Drug: Ibuprofen; Drug: Pantoprazole; Drug: Methocarbamol; Drug: Opioid

Ketamine Infusion

EXPERIMENTAL

Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion. All patients will undergo Intercostal Nerve Blockade with administration of scheduled medications including acetaminophen, ibuprofen, pantoprazole, and methocarbamol. All subjects will receive adjunct opioids.

Drug: Ketamine; Procedure: Intercostal Nerve Block; Drug: Acetaminophen; Drug: Ibuprofen; Drug: Pantoprazole; Drug: Methocarbamol; Drug: Opioid

Interventions

Ketamine DRUG

All individuals randomized to the experimental arm of the trial will receive early ketamine therapy (within 6 hours of admission) at a rate of 0.15 mg/kg/hr dosed based on ideal body weight. Individuals in the control arm will receive our standard of care for thoracic trauma patients, however, they will receive an additional placebo infusion of normal saline.

Ketamine Infusion

Placebo DRUG

Individuals enrolled into the control arm of the trial will receive a normal saline placebo infusion at a rate equivalent to the dosage of ketamine in the experimental arm.

Also known as: NaCl Placebo Solution

Placebo Infusion

Intercostal Nerve Block PROCEDURE

All individuals enrolled into the trial will undergo an Intercostal Nerve Blockade as a part of the institutional standard of care for rib fractures. This procedure will be performed according to current standard protocols in the Emergency Department or on admission.

Also known as: Rib Block

Ketamine Infusion; Placebo Infusion

Acetaminophen DRUG

All patients admitted to the hospital will be placed on scheduled acetaminophen 1000mg PO q 6 hours unless signs of liver disease/impairment or creatinine clearance \< 35ml/min at which point dosage would be reduced to 650mg q 8 hours. Individuals unable to take oral medications would be placed on intravenous acetaminophen.

Also known as: Tylenol

Ketamine Infusion; Placebo Infusion

Ibuprofen DRUG

All patients will be placed on scheduled Ibuprofen or an equivalent NSAID at dosage of 600mg every 6 hours. Patients must have a Glomerular Filtration Rate \> 60 ml/min with no contraindications to NSAID therapy (e.g. Aspirin use, allergy/sensitivity, concurrent ACE inhibitor use, other nephrotoxins, etc)

Also known as: Advil, Motrin

Ketamine Infusion; Placebo Infusion

Pantoprazole DRUG

All individuals on scheduled Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy will receive scheduled pantoprazole at 40mg daily. Individuals unable to take medications orally will be placed on intravenous therapy. Individuals with previous reaction or intolerance to pantoprazole will be placed on an equivalent proton pump inhibitor.

Also known as: Protonix

Ketamine Infusion; Placebo Infusion

Methocarbamol DRUG

All individuals enrolled in the trial will be placed on scheduled methocarbamol 500 mg orally every 6 hours while admitted. Individuals with previous intolerance to methocarbamol will be placed on a pharmacy directed equivalent.

Also known as: Robaxin

Ketamine Infusion; Placebo Infusion

Opioid DRUG

All individuals will receive as needed opiate therapy as an adjunct to the scheduled medications and "ketamine/placebo" solution. Choice in opiate therapy will be at the discretion of the attending trauma faculty. Dosage and adjustments will be in accordance with the institutional policy on appropriate opiate dosage adjustment.

Also known as: opiate, narcotic

Ketamine Infusion; Placebo Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than 18 years
• rib fractures following recent trauma with admission to Froedtert Memorial Lutheran Hospital

You may not qualify if:

• history of adverse reaction / intolerance to ketamine therapy
• elevated intracranial pressure
• ischemic heart disease defined as active acute coronary syndrome
• severe, poorly controlled hypertension (Systolic Blood Pressure \> 200 mmHg or Diastolic Blood Pressure \> 100 mmHg)
• current opiate agonist/antagonist therapy
• concurrent use of monoamine oxidase inhibitors (MAOIs)
• chronic pain or opioid tolerance defined as \> 3 weeks of \>30mg oral morphine equivalents per day
• current substance abuse with opiates (prescription and/or heroin) or ketamine
• Glasgow Coma Scale \<13
• Intubation on arrival or need for urgent intubation on arrival
• inability to delineate pain and/or appropriately communicate with staff
• history of psychosis
• three or more psychotropic medications
• active delirium
• glaucoma

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Carver TW, Kugler NW, Juul J, Peppard WJ, Drescher KM, Somberg LB, Szabo A, Yin Z, Paul JS. Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial. J Trauma Acute Care Surg. 2019 Feb;86(2):181-188. doi: 10.1097/TA.0000000000002103.

  PMID: 30376537 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Rib Fractures

Interventions

Ketamine; Acetaminophen; Ibuprofen; Pantoprazole; Methocarbamol; Analgesics, Opioid; Opiate Alkaloids; Narcotics

Condition Hierarchy (Ancestors)

Fractures, Bone; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylcarbamates; Carbamates; Acids, Acyclic; Guaifenesin; Guaiacol; Methyl Ethers; Ethers; Phenyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Alkaloids

Limitations and Caveats

NPS presents challenges as pain is subjective and difficult to assess. Treating providers were allowed any medications within the multimodal rib fracture pain protocol leading to non-standardized pain regimens based on providers.

Results Point of Contact

• Title: Thomas Carver
• Organization: Medical College of Wisconsin

tcarver@mcw.edu

414-955-1733

Study Officials

• Thomas W Carver, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Research Resident

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: May 4, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Locations

US (1)