Randomized, interventional trial of Emergency Department (ED) administration of DSUVIA (sufentanil) versus standard care pain management comparing pain treatment outcomes in injured patients with moderate to severe pain
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
30 microgram sublingual tablet administered using sublingual applicator
standard care pain treatment given in Emergency Department
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Verbally Administered Numeric Rating Scale (VNRS)
Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)
Time frame: 30 minutes after administration
Verbally Administered Numeric Rating Scale (VNRS)
Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain)
Time frame: Every 30 min from 30 min post administration until the time of ED discharge or rescue narcotic administered and up to 120 minutes after administration, whichever comes first
Patient Global Assessment (PGA) of Pain Control
An assessment of the patient's pain, made by the patient themselves, made at 30 minute intervals up to 120 min after the intervention, or until discharge, or administration of rescue medication
Time frame: every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min
time-weighted Summed Pain Intensity Difference (SPID) is a statistical measure that calculates the cumulative pain reduction over a period of time by summing up the differences between baseline pain and current pain at various time points. The range for the SPID is 0-100 per time point, A score of 0 indicates no pain, a score of 100 indicating the worst pain intensity difference. Some patients did not participate in the SPID due to discharge or requiring rescue narcotic administration.
Time frame: every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration)
Number of Participants Who Needed Rescue Narcotic Doses
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Count of patients requiring additional pain medication after recieving the intervention (sufentanil) or the standard care control.
Time frame: at 30 minutes following administration and during ED stay (up to 120 minutes)
Patient Cognitive Function as Assessed by Six Item Screener (SIS)
The Six Item Screener (SIS) is a simple assessment of cognitive impairment. It asks 6 questions, 3 based on recall and 3 based on orientation, each question is worth 1 point. The score can range between 0 and 6 correct answers. Higher numbers of correct answers indicated better outcomes (less cognitive impairment). Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey.
Time frame: at 30 minutes following administration
Healthcare Professional Global Assessment (HPGA) of Method of Pain Control
Acceptability of pain treatment to health care providers based on a subjective assessment of the patients facial expressions, behavior, physical presentation and reported pain level. Nurses caring for the participant following treatment with the study drug were asked to characterize their patients pain relief as Poor, Fair, Good or Excellent.
Time frame: at 30 minutes following administration
Number of Participants With Hypoxia Needing Supplemental Oxygen
The number of patients with an SpO2 less than 90 percent receiving supplemental oxygen
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Hypotension
systolic blood pressure less than 90mmHg
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Nausea
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Vomiting
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Headache
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants With Dizziness Requiring Treatment
Dizziness requiring treatment
Time frame: from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes)
Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min
The Number of participants that had a 10 point reduction in their VNRS @ 30min intervals to 120min
Time frame: Time to a 10 point reduction in VNRS following administration of study drug. Participants were followed to 120 min or discharge in 30 min intervals
Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management
Need for advanced airway or bag valve mask ventilation
Time frame: From drug administration up to 120 min following administration
Richmond Agitation-Sedation Scale (RASS)
The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm.
Time frame: Assessed at 30 minutes after administration
Richmond Agitation-Sedation Scale (RASS) @ 60 Min
The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey.
Time frame: RASS @ 60 min
Richmond Agitation-Sedation Scale (RASS) @ 90 Min
The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm.Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey.
Time frame: RASS @ 90 minutes
Richmond Agitation-Sedation Scale (RASS) @ 120 Min
The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. Fewer patients were able to complete the SIS questionnaire then were enrolled in the study as some were discharged, received rescue medication or declined to participate prior to administration of the survey.
Time frame: RASS @ 120 min