Trial · NCT01859715
Emergency Department (ED) Drug Interaction in Emergency Department Patients
NCT01859715, Not applicable, Completed, University of Colorado, Denver; results first posted 2016-05-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Emergency Department (ED) Drug Interaction in Emergency Department Patients. Trials, record NCT01859715. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01859715
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Emergency Department (ED) Drug Interaction in Emergency Department Patients
- NCT number
- NCT01859715
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 502 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Drug Interactions
- Interventions
- Oxycodone, Hydrocodone, Ondansetron
- First posted
- 2013-05-22
- Last updated
- 2016-05-05
- Results first posted
- 2016-05-05
- Limitations and caveats
- These data are limited by the nature of self-reported medication ingestion histories and self-reported effectiveness measures for opioid pain medications.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users | Baseline and 90 minutes | Clinically significant visual analogue scale (VAS; a measure of adult pain and nausea on a scale of 1-100 millimeters for increasing symptoms of pain and nausea) for patients who were administered either oxycodone, hydrocodone/acetaminophen, or ondansetron in the ED. Clinically significant change was defined as 13mm change on the VAS from baseline (when first VAS was completed) to 90 minutes following drug administration in the ED. |
| Secondary | Adverse Drug Events | Duration of ED stay, <24 hours. (up to 24 hours) | Determine all possible adverse drug events that occurred after the study drugs were administered. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users | Baseline and 90 minutes | millimeters | MEAN | |
| SECONDARY | Adverse Drug Events | Duration of ED stay, <24 hours. (up to 24 hours) | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users | Oxycodone Group | 7.4 | 95% Confidence Interval -0.8 to 15.6 | millimeters | |
| Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users | Hydrocodone/Acetaminophen Group | 10.9 | 95% Confidence Interval 0.8 to 21.1 | millimeters | |
| Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users | Nausea-observational Group | -14.0 | 95% Confidence Interval -23.6 to -4.4 | millimeters | |
| Adverse Drug Events | Oxycodone Group | 0 | participants | ||
| Adverse Drug Events | Hydrocodone/Acetaminophen Group | 0 | participants | ||
| Adverse Drug Events | Nausea-observational Group | 0 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oxycodone Group | 141 | |
| Overall Study | STARTED | Hydrocodone/Acetaminophen Group | 91 | |
| Overall Study | STARTED | Nausea-observational Group | 116 | |
| Overall Study | COMPLETED | Oxycodone Group | 125 | |
| Overall Study | COMPLETED | Hydrocodone/Acetaminophen Group | 83 | |
| Overall Study | COMPLETED | Nausea-observational Group | 93 | |
| Overall Study | NOT COMPLETED | Oxycodone Group | 16 | |
| Overall Study | NOT COMPLETED | Hydrocodone/Acetaminophen Group | 8 | |
| Overall Study | NOT COMPLETED | Nausea-observational Group | 23 |
Source ClinicalTrials.gov
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 totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oxycodone Group | ||
| Total, all-cause mortality | Hydrocodone/Acetaminophen Group | ||
| Total, all-cause mortality | Nausea-observational Group | ||
| Total, other adverse events | Oxycodone Group | 0 | 141 |
| Total, other adverse events | Hydrocodone/Acetaminophen Group | 0 | 91 |
| Total, other adverse events | Nausea-observational Group | 0 | 116 |
| Total, serious adverse events | Oxycodone Group | 0 | 141 |
| Total, serious adverse events | Hydrocodone/Acetaminophen Group | 0 | 91 |
| Total, serious adverse events | Nausea-observational Group | 0 | 116 |
Source ClinicalTrials.gov
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/NCT01859715
GET https://conductscience.org/api/trials/v1/NCT01859715/registered