Trial · NCT05288348
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Verbally Administered Numeric Rating Scale (VNRS) | 30 minutes after administration | Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain) |
| Secondary | Verbally Administered Numeric Rating Scale (VNRS) | 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 | Verbally administered Numeric Rating Scale (VNRS) for clinical pain measurement (scale of 0-100, where 0 is having no pain) |
| Secondary | Patient Global Assessment (PGA) of Pain Control | every 30 minutes after administration until the time of ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration) | 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 |
| Secondary | Time-weighted Summed Pain Intensity Difference (SPID) @ 30, 60, 90, 120 Min | every 30 minutes after administration until ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes after administration) | 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. |
| Secondary | Number of Participants Who Needed Rescue Narcotic Doses | at 30 minutes following administration and during ED stay (up to 120 minutes) | Count of patients requiring additional pain medication after recieving the intervention (sufentanil) or the standard care control. |
| Secondary | Patient Cognitive Function as Assessed by Six Item Screener (SIS) | at 30 minutes following administration | 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. |
| Secondary | Healthcare Professional Global Assessment (HPGA) of Method of Pain Control | at 30 minutes following administration | 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. |
| Secondary | Number of Participants With Hypoxia Needing Supplemental Oxygen | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | The number of patients with an SpO2 less than 90 percent receiving supplemental oxygen |
| Secondary | Number of Participants With Hypotension | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | systolic blood pressure less than 90mmHg |
| Secondary | Number of Participants With Nausea | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | |
| Secondary | Number of Participants With Vomiting | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | |
| Secondary | Number of Participants With Headache | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | |
| Secondary | Number of Participants With Dizziness Requiring Treatment | from administration to ED discharge or rescue narcotic administered, whichever comes first (up to 120 minutes) | Dizziness requiring treatment |
| Secondary | Number of Participants Who Had a 10 Point Reduction in VNRS Score @30 Min Intervals to 120min | 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 | The Number of participants that had a 10 point reduction in their VNRS @ 30min intervals to 120min |
| Secondary | Number of Participants With Need for Bag Valve Mask Ventilation or Advanced Airway Management | From drug administration up to 120 min following administration | Need for advanced airway or bag valve mask ventilation |
| Secondary | Richmond Agitation-Sedation Scale (RASS) | Assessed at 30 minutes after administration | The Richmond Agitation-Sedation Scale is scored from a -5 (unresponsive) to +4 (combative) with 0 being alert and calm. |
| Secondary | Richmond Agitation-Sedation Scale (RASS) @ 60 Min | 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. |
| Secondary | Richmond Agitation-Sedation Scale (RASS) @ 90 Min | RASS @ 90 minutes | 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. |
| Secondary | Richmond Agitation-Sedation Scale (RASS) @ 120 Min | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05288348/registered