Trial · NCT03635684
Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen
NCT03635684, Phase 2, Completed, Saint-Joseph University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen. Trials, record NCT03635684. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03635684
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen
- NCT number
- NCT03635684
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Saint-Joseph University
- Conditions
- Pain, Fever, Drug Effect, Drug Reaction
- Interventions
- Acetaminophen
- First posted
- 2018-08-17
- Last updated
- 2020-06-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Numerical Rating Scale pain scores for conscious and cooperative patients | 60 minutes | This outcome measures the decrease in pain scores between t0 (right before acetaminophen administration) and t60 minutes using the Numerical Rating Scale in conscious and cooperative patients, where 10/10 is the worst imaginable pain and 0/10 is no pain at all. A Minimal Clinically Important Difference (MCID) of 2/10 is set to define efficacy. |
| Primary | Change on Algoplus Pain Scale for patients with verbal communication difficulties | 60 minutes | This outcome measures the decrease in pain scores between t0 (right before acetaminophen administration) and t60 minutes using Algoplus Scale, a behavioural rating scale for acute pain for patients with verbal communication difficulties. A score of 2 or above diagnoses pain with 87% sensitivity and 80% specificity. The scale evaluates facial expressions, look, complaints, body position and atypical behaviours of patients with verbal communication difficulties. Each item marked "yes" is awarded one point and the total across all the items gives a total score out of 5. Efficacy is defined as a decrease of the score to less than 2/5. |
| Primary | Change in temperature measurement | 60 minutes | Decrease in temperature measurement. A Minimal Clinically Important Difference (MCID) of 0.5 degrees Celsius is set to define efficacy. |
| Primary | Appearance of local side effects | at the time of perfusion, after 30 minutes, 60 minutes and 180 minutes, and one day after line removal | Any local side effect is reported, including: * edema, * induration, * erythema, * tenderness, * warmth, * abcess, * necrosis |
| Secondary | Early effect on pain in conscious and cooperative patients | 30 minutes | To evaluate if any early effect on pain is measurable, this outcome measures the pain scores at t30 minutes using the Numerical Rating Scale in conscious and cooperative patients, where 10/10 is the worst imaginable pain and 0/10 is no pain at all. |
| Secondary | Sustained effect on pain in conscious and cooperative patients | 180 minutes | To evaluate if the effect on pain is sustained over time, this outcome measures the pain scores at t180 minutes using the Numerical Rating Scale in conscious and cooperative patients, where 10/10 is the worst imaginable pain and 0/10 is no pain at all. |
| Secondary | Early effect on pain in patients with verbal communication difficulties | 30 minutes | To evaluate if any early effect on pain is measurable, this outcome measures the pain scores at t60 minutes and t180 minutes using Algoplus Scale, a behavioural rating scale for acute pain for patients with verbal communication difficulties. A score of 2 or above diagnoses pain with 87% sensitivity and 80% specificity. The scale evaluates facial expressions, look, complaints, body position and atypical behaviours of patients with verbal communication difficulties. Each item marked "yes" is awarded one point and the total across all the items gives a total score out of 5. |
| Secondary | Sustained effect on pain in patients with verbal communication difficulties | 180 minutes | To evaluate if the effect on pain is sustained over time, this outcome measures the pain scores at t180 minutes using Algoplus Scale, a behavioural rating scale for acute pain for patients with verbal communication difficulties. A score of 2 or above diagnoses pain with 87% sensitivity and 80% specificity. The scale evaluates facial expressions, look, complaints, body position and atypical behaviours of patients with verbal communication difficulties. Each item marked "yes" is awarded one point and the total across all the items gives a total score out of 5. |
| Secondary | Early effect on fever | 30 minutes | To evaluate if any early effect on fever is measurable, temperature is measured at t30 minutes. |
| Secondary | Sustained effect on fever | 180 minutes | To evaluate if the effect on fever is sustained over time, temperature is measured at t180 minutes |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03635684
GET https://conductscience.org/api/trials/v1/NCT03635684/registered