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Trial · NCT05102591

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYAssessment of Recruitment RateEvaluated monthly and at the end of recruitment (i.e., 2 years or once the final participant has completed the study)
Number of participants who were screened, deemed eligible, and subsequently enrolled. Three (3) participants during the parallel-group design phase withdrew after consent but before being randomized/receiving study treatments. No other participants withdrew during the study.
participants per monthMEAN
SECONDARYReduction in Pain SeverityDifference between baseline and 1 hour, 2 hours, and 48 hours post-intervention.
Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol).
units on a scaleMEAN
SECONDARYNumber of Eligible Participants Who Are Screened, Enrolled, and Complete All AssessmentsEvaluated monthly and at the end of recruitment (i.e., 2 years or once the final participant has completed the study)
Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol).
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYGlobal Impression of ChangeEvaluated for each participant at 2-hours post-intervention, and 48-hours post-intervention
Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol).
participantsNUMBER
SECONDARYStudy Feedback From Participants and StaffParticipant feedback evaluated at 48 hours post-intervention
Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol).
units on a scaleMEAN
SECONDARYNumber of Participants Reporting Pain Freedom2 hours post-intervention
Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol).
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Reporting Sustained Pain Freedom48 hours post-intervention
Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol).
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumbers of Participants Reporting a Change in 4-point Pain Severity Scale Between Baseline and 2 Hours Post-intervention2 hours post-intervention
Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol).
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Reporting Sustained Pain Relief48 hours post-intervention
Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol).
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Reporting Adverse EventsEvaluated from time of intervention to 2 hours and 48 hours post-intervention
Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol).
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Reporting Freedom From Most Bothersome Symptom2 hours post-intervention
Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol).
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Discharged From the Emergency Department With no Further Intervention2 hours post-intervention (after last intervention, following ED discharge)
Treatment data are combined across phases, separated based on treatment given and time given to be consistent with how we specified results would be reported in the protocol (i.e., ...for both the initial assigned intervention and the crossover intervention where applicable). Participants who received SoC IV at crossover received REN initially, and vice versa. No participants received REN crossover treatment as they were well enough to go home after the initial IV treatment (as per protocol).
ParticipantsCOUNT_OF_PARTICIPANTS

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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