Trial · NCT05437575
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 24-hour mortality | trauma bay arrival through 24 hours | All cause mortality within 24 hours from time of trauma bay arrival |
| Secondary | Hypoxia | from initial administration of PAIN prehospital analgesia through hospital arrival | incidence of hypoxia in the prehospital environment |
| Secondary | Hypotension | from initial administration of PAIN study prehospital analgesia through hospital arrival | incidence of hypotension in the prehospital environment |
| Secondary | Need for airway management | from initial administration of PAIN study prehospital analgesia through hospital arrival | need for airway management in the prehospital environment |
| Secondary | Prehospital pain assessment following analgesia | from initial administration of PAIN study prehospital analgesia through hospital arrival | prehospital pain assessment using Numeric Rating Scale (NRS)/Critical Care Pain Observational Tool (CPOT) scores. For Numeric Rating Scale, the patient rates their pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain. The Critical Care Pain Observation Tool is used for patients who are intubated and cannot verbalize a pain score. Medical staff will observe the patient's behavior and score the patient's pain on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain. |
| Secondary | Trauma bay arrival pain score | score assessed at time of arrival to trauma bay | pain assessment using Numeric Rating Scale (NRS)/Critical Care Pain Observation Tool (CPOT) score. For Numeric Rating Scale, patients rate their pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain. The Critical Care Pain Observation Tool is used for patients who are intubated and cannot verbalize a pain score. A nurse will observe behavior and score the patient's pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain. |
| Secondary | Number of analgesic doses necessary to reduce pain level to <5 NRS or CPOT less than 2 | from initial administration of PAIN study prehospital analgesia through hospital arrival | Number of analgesic doses necessary to reduce pain level to \<5 on Numeric Rating Scale or less than 2 on Critical Care Pain Observation Tool. For Numeric Rating Scale, the patient rates their pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain. The Critical Care Pain Observation Tool is used for patients who are intubated and cannot verbalize a pain score. A nurse will observe behavior and score the patient's pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain. |
| Secondary | 24 hour opioid use | from initial administration of PAIN study prehospital analgesia through 24 hours | total 24 hour opioid use |
| Secondary | Incidence of prehospital adverse events | from initial administration of PAIN study prehospital analgesia through hospital arrival | Incidence of adverse events of allergic reaction, emergence, laryngospasm, dysphoria, pruritus, and nausea |
| Secondary | Survival to hospital discharge | administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days | survival to hospital discharge |
| Secondary | Ventilator free days | from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days | ventilator free days. Ventilator days are defined as number of days recorded to the first decimal spent on a mechanical ventilator subtracted from 30 |
| Secondary | Intensive Care Unit free days | from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days | number of days recorded to the first decimal spent admitted to the Intensive Care Unit subtracted rom 30 |
| Secondary | Long term opioid use | 3 months (+/- 1 month) and 6 months (+/- 1 month) following trauma admission | long term opioid use assessed at 3 and 6 months. Patients who consent to further participation will be contacted to determine if they continued to use opioids (yes/no) at 3 and 6 months following trauma admission |
| Secondary | Hospital length of stay | from time of hospital admission to discharge | number of days recorded to the first decimal from hospital admission to discharge up to 30 days |
| Secondary | Baseline Pain/Anxiety/PTSD screening | 0 hours to 2 weeks from time of hospital admission | A subset of patients who consent to further participation will be assessed for Anxiety/PTSD using the Four-Item Patient Health Questionnaire (PHQ-4) for anxiety and depression, a two item pain severity scale (0=no pain to 10=worst pain), and the Injured Trauma Survivor Screen (ITSS) |
| Secondary | Long term (6 month) outcome | 6 months +/- 1 month following trauma admission | A subset of patients who consent to further participation will be assessed for anxiety/depression/PTSD symptoms using the following tools: Generalized Anxiety Disorder (GAD-7), 8 item Patient Health Questionnaire (PHQ-8), and 8 item PTSD checklist (PCL-5) |
| Secondary | Long Term Pain Assessment | At 3 and 6 months (+/- 1 month) after hospital arrival | A subset of patients who consent to further participation will be assessed for long term pain using a modified Brief Pain Inventory (numerical scale rating 0-10) |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05437575/registered