Phase 4
N=150
Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients
Wounds and Injuries · Rib Fractures
Bottom Line
View on ClinicalTrials.gov: NCT02432456 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Visual Analog Numeric Pain Score — 6.1; 5.7; 5.2; 5.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ketamine (Drug); Placebo (Drug); Intercostal Nerve Block (Procedure); Acetaminophen (Drug); Ibuprofen (Drug); Pantoprazole (Drug); Methocarbamol (Drug); Opioid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Numeric Pain Score |
5.8; 5.6; 4.4; 5.1 | — |
| SECONDARY Visual Analog Numeric Pain Score |
5.8; 5.6; 4.4; 5.1 | — |
| SECONDARY Oral Morphine Equivalent (Narcotic Usage) |
67; 69.0; 44; 25 | — |
| SECONDARY Oral Morphine Equivalent (Narcotic Usage) |
67; 69.0; 44; 25 | — |
| SECONDARY Length of Stay |
4.0; 5; 6; 5 | — |
| SECONDARY Regional Anesthesia Utilization |
3; 7; 6; 4 | — |
| SECONDARY Respiratory Failure |
3; 2; 0; 0 | — |
| SECONDARY Hallucination |
1; 0; 2; 2 | — |
| SECONDARY Oral Morphine Equivalent (Narcotic Usage) in Severely Injured |
170.5; 153.0; 86.8; 67.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- age greater than 18 years
- rib fractures following recent trauma with admission to Froedtert Memorial Lutheran Hospital
Exclusion Criteria
- 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
- pregnancy
- prisoners
Data sourced from ClinicalTrials.gov (NCT02432456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.