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Trial · NCT06160778

Registered outcomes23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPain relief as measured on the verbal numerical rating scale60 minutes post drug administrationBetween group mean differences in pain as measured on an 11-point verbal Numerical Rating Scale (0 is no pain and 10 is worst pain ever)
SecondaryPain relief as measured on the verbal numerical rating scale30 minutes post drug administrationBetween group mean differences in pain as measured on an 11-point verbal
SecondaryPain relief as measured on the verbal numerical rating scale90 minutes post drug administrationBetween group mean differences in pain as measured on an 11-point verbal
SecondaryPain relief as measured on the verbal numerical rating scale120 minutes post drug administrationBetween group mean differences in pain as measured on an 11-point verbal
SecondaryPain relief as measured on the verbal numerical rating scale6 hours post drug administrationBetween group mean differences in pain as measured on an 11-point verbal
SecondaryPain relief as measured on the verbal numerical rating scale during the ultrasound diagnosticup to 6 hours post drug administrationscore from 0-10 on verbal numerical rating scale
SecondaryProportion who achieve the minimal important difference for pain relief60 minutes post drug administrationProportion of participants who achieves the 2-point verbal Numerical Rating Scale minimal important difference pain score reduction
SecondaryProportion who achieve the minimal important difference for pain relief120 minutes post drug administrationProportion of participants who achieves the 2-point verbal Numerical Rating Scale minimal important difference pain score reduction
SecondaryChange in baseline pain category30 minutes post drug administrationProportion of participants who change the severity of their baseline pain category. Pain categories on the verbal numerical rating scale as follows: mild = 0 to 4, moderate = 5 to 7, severe \>7)
SecondaryChange in baseline pain category60 minutes post drug administrationProportion of participants who change the severity of their baseline pain category. Pain categories on the verbal numerical rating scale as follows: mild = 0 to 4, moderate = 5 to 7, severe \>7)
SecondaryChange in baseline pain category90 minutes post drug administrationProportion of participants who change the severity of their baseline pain category. Pain categories on the verbal numerical rating scale as follows: mild = 0 to 4, moderate = 5 to 7, severe \>7)
SecondaryChange in baseline pain category120 minutes post drug administrationProportion of participants who change the severity of their baseline pain category. Pain categories on the verbal numerical rating scale as follows: mild = 0 to 4, moderate = 5 to 7, severe \>7)
SecondaryChange in baseline pain category6 hours post drug administrationProportion of participants who change the severity of their baseline pain category. Pain categories on the verbal numerical rating scale as follows: mild = 0 to 4, moderate = 5 to 7, severe \>7)
SecondaryTime to effective analgesiaup to 6 hours post drug administrationDuration of time from time of drug administration to time at which a verbal Numerical Rating Scale ≤3 is achieved.
SecondaryAdditional analgesia requirmentup to 6 hours post drug administrationProportion of participants requiring any additional analgesia in each trial arm
SecondaryTotal opioids administeredup to 8 hours post drug administrationtotal morphine-equivalent mg/kg administered for all trial participants
SecondaryRamsay sedation score30 minutes post drug administrationAssessment of sedation levels post drug administration; score is 1-6 (1 is alert, 6 is not responsive)
SecondaryRamsay sedation score60 minutes post drug administrationAssessment of sedation levels post drug administration; score is 1-6 (1 is alert, 6 is not responsive)
SecondaryRamsay sedation score90 minutes post drug administrationAssessment of sedation levels post drug administration; score is 1-6 (1 is alert, 6 is not responsive)
SecondaryRamsay sedation score120 minutes post drug administrationAssessment of sedation levels post drug administration; score is 1-6 (1 is alert, 6 is not responsive)

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.

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