Clinical trial NCT04061330: Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures
Official title: Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pain, Acute
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish the feasibility of initiating a ketamine pain control protocol in the emergency department for the treatment of acute pain in patients with long bone fractures and to compare the efficacy of the ketamine pain protocol to bolus morphine for pain control in the first 6 hours of patient stay in the emergency department.


Eligibility criteria: Inclusion Criteria:

* patients presenting to the ED with long bone fracture, open or closed.Long bone fractures include:humerus, radius, ulna, femur, tibia, fibula.

Exclusion Criteria:

* Received morphine in the ED prior to enrollment
* Received ketamine any time prior to enrollment
* Glasgow Coma Scale(GCS) less than 15
* Transferred from other facility
* Other moderate to severe trauma injuries
* Contraindication to ketamine
* Cannot consent (no intubation, airway issues, hemodynamic instability)
* Prisoners
* Suspected and/or confirmed pregnancy

Primary outcomes:
measure: Clinical pain as assessed by the Numerical pain rating score (NPRS)
timeFrame: baseline
measure: Clinical pain as assessed by the Numerical pain rating score (NPRS)
timeFrame: 5 minutes after initial administration of drug
measure: Clinical pain as assessed by the Numerical pain rating score (NPRS)
timeFrame: 10 minutes after initial administration of drug
measure: Clinical pain as assessed by the Numerical pain rating score (NPRS)
timeFrame: 30 minutes after initial administration of drug
measure: Clinical pain as assessed by the Numerical pain rating score (NPRS)
timeFrame: 60 minutes after initial administration of drug
measure: Clinical pain as assessed by the Numerical pain rating score (NPRS)
timeFrame: 2 hours after initial administration of drug
measure: Clinical pain as assessed by the Numerical pain rating score (NPRS)
timeFrame: 3 hours after initial administration of drug
measure: Clinical pain as assessed by the Numerical pain rating score (NPRS)
timeFrame: 4 hours after initial administration of drug
measure: Clinical pain as assessed by the Numerical pain rating score (NPRS)
timeFrame: 5 hours after initial administration of drug
measure: Clinical pain as assessed by the Numerical pain rating score (NPRS)
timeFrame: 6 hours after initial administration of drug
Secondary outcomes:
measure: Number of hypoxic episodes as measured with a continuous pulse oximeter
timeFrame: 5 minutes after initial administration of drug
measure: Number of hypoxic episodes as measured with a continuous pulse oximeter
timeFrame: 10 minutes after initial administration of drug
measure: Number of hypoxic episodes as measured with a continuous pulse oximeter
timeFrame: 30 minutes after initial administration of drug
measure: Number of hypoxic episodes as measured with a continuous pulse oximeter
timeFrame: 60 minutes after initial administration of drug
measure: Number of hypoxic episodes as measured with a continuous pulse oximeter
timeFrame: 2 hours after initial administration of drug
measure: Number of hypoxic episodes as measured with a continuous pulse oximeter
timeFrame: 3 hours after initial administration of drug
measure: Number of hypoxic episodes as measured with a continuous pulse oximeter
timeFrame: 4 hours after initial administration of drug
measure: Number of hypoxic episodes as measured with a continuous pulse oximeter
timeFrame: 5 hours after initial administration of drug
measure: Number of hypoxic episodes as measured with a continuous pulse oximeter
timeFrame: 6 hours after initial administration of drug
measure: Number of hypotension episodes
timeFrame: 5 minutes after initial administration of drug
measure: Number of hypotension episodes
timeFrame: 10 minutes after initial administration of drug
measure: Number of hypotension episodes
timeFrame: 30 minutes after initial administration of drug
measure: Number of hypotension episodes
timeFrame: 60 minutes after initial administration of drug
measure: Number of hypotension episodes
timeFrame: 2 hours after initial administration of drug
measure: Number of hypotension episodes
timeFrame: 3 hours after initial administration of drug
measure: Number of hypotension episodes
timeFrame: 4 hours after initial administration of drug
measure: Number of hypotension episodes
timeFrame: 5 hours after initial administration of drug
measure: Number of hypotension episodes
timeFrame: 6 hours after initial administration of drug
measure: Score on Richmond Agitation-Sedation Scale (RASS)
timeFrame: 5 minutes after initial administration of drug
measure: Score on Richmond Agitation-Sedation Scale (RASS)
timeFrame: 10 minutes after initial administration of drug
measure: Score on Richmond Agitation-Sedation Scale (RASS)
timeFrame: 30 minutes after initial administration of drug
measure: Score on Richmond Agitation-Sedation Scale (RASS)
timeFrame: 60 minutes after initial administration of drug
measure: Score on Richmond Agitation-Sedation Scale (RASS)
timeFrame: 2 hours after initial administration of drug
measure: Score on Richmond Agitation-Sedation Scale (RASS)
timeFrame: 3 hours after initial administration of drug
measure: Score on Richmond Agitation-Sedation Scale (RASS)
timeFrame: 4 hours after initial administration of drug
measure: Score on Richmond Agitation-Sedation Scale (RASS)
timeFrame: 5 hours after initial administration of drug
measure: Score on Richmond Agitation-Sedation Scale (RASS)
timeFrame: 6 hours after initial administration of drug
measure: Number of participants with need for rescue opioid therapy
timeFrame: from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug)
measure: Number of participants with need for rescue benzodiazepine therapy in ketamine group for emergence phenomenon and dysphoria
timeFrame: from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug)
measure: Number of participants with Adverse reactions
timeFrame: from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug)
measure: Patient satisfaction with analgesia
timeFrame: end of treatment (about 6 hours after initial administration of drug)
measure: Physician satisfaction with analgesia
timeFrame: end of treatment (about 6 hours after initial administration of drug)
measure: Nursing satisfaction with analgesia
timeFrame: end of treatment (about 6 hours after initial administration of drug)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Paulina Sergot, MD
role: PRINCIPAL_INVESTIGATOR
References: