Trial · NCT04195256
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adequate sedation | Through study completion in the ED (4 hours) | Adequate is defined as fulfillment of all three of the following criteria: (i) A Pediatric Sedation State Scale (PSSS) score of 2 or 3 for the duration of the procedure (defined for closed reduction as the interval of time from the first application of traction or manipulation of the injured limb for the purpose of anatomical realignment to the last application of a realigning force). The PSSS is scored from 0 to 5 in discrete integer values every 15 seconds. A score of 4 or 5 indicates under-sedation and a score of 0 or 1 indicates over sedation. (ii) No additional medication is given during the procedure for the purpose of sedation. (iii) The patient did not actively resist, cry, or require physical restraint for completion of the closed reduction. |
| Secondary | Length of stay | Through study completion in the ED (4 hours) | Defined as the time recorded in the medical record between triage and discharge. |
| Secondary | Time to wakening | Through study completion in the ED (4 hours) | This will be defined as the duration of time between the first pair of IN sprays and the first PSSS score of \> 3 post-closed reduction. |
| Secondary | Adverse effects | Through study completion in the ED and up to 72 hours post-discharge | Adverse effects as defined by Health Canada reporting standards |
| Other | Length of stay due to procedural sedation | Through study completion in the ED (4 hours) | Defined as the time interval from the first pair of IN sprays/IV dose to discharge, reflective of the time difference associated with different routes of administration. |
| Other | Duration of procedure | Through study completion in the ED (4 hours) | Defined as time of the first pair of IN sprays to the end of cast or splint application (closed reduction) in minutes |
| Other | Caregiver, participant, bedside nurse or respiratory therapist, and physician satisfaction | Through study completion in the ED (4 hours) | Satisfaction will be measured using a visual analog scale (VAS) when the participant is deemed ready for discharge. The following questions will be posed: How satisfied were you with your child's sedation? (Caregiver if at bedside), How happy were you with your sleep? (Participant), or How satisfied were you with the level of sedation in your patient? (Sedating physician \& nurse/respiratory therapist as per who is at bedside). |
| Other | Nasal irritation | Through study completion in the ED (4 hours) | Discomfort associated with nasal sprays will be assessed by the research nurse using the Faces Pain Scale -Revised (FPS-R) when the participant is deemed ready for discharge. The FPS-R is a self-report measure scored as either 0,2,4,6,8,10, with increasing numbers indicating greater pain. |
| Other | Volume of IN intervention received / Volume of IN intervention intended | Through study completion in the ED (4 hours) | Volume of IN intervention received / Volume of IN intervention intended |
| Other | Adjunctive IV therapy and medications | Through study completion in the ED (4 hours) | The number of participants requiring an IV for therapy unrelated to sedation (eg. analgesics, antibiotics, antiemetics, fluids) will be recorded. |
| Other | Pre-sedation Pain | Through study completion in the ED (4 hours) | Will be recorded by the research nurse from the participant using the Faces Pain Scale - Revised (FPS-R) immediately prior to the first pair of intranasal sprays |
| Other | Patient Preference | Through study completion in the ED (4 hours) | The following question will be posed to the child: "If you were to be put to sleep again for an injury, what would you prefer, an intravenous needle or nasal sprays (choose one)?" |
| Other | Exploratory subgroup analyses | Through study completion in the ED (4 hours) | A planned subgroup analyses to determine whether the between group difference in adequacy of sedation is dependent on (i) pain score prior to sedation. |
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/NCT04195256/registered