Trial · NCT01402375
Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge
NCT01402375, Phase 3, Completed, Montefiore Medical Center; results first posted 2018-05-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge. Trials, record NCT01402375. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01402375
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge
- NCT number
- NCT01402375
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 720 participants, actual
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Analgesia After ED Discharge for Extremity Injuries
- Interventions
- Hydrocodone (first trial), Codeine (first trial), Oxycodone (for second trial), Codeine (for second trial), Oxycodone (third trial), Hydrocodone (third trial)
- First posted
- 2011-07-26
- Last updated
- 2018-05-01
- Results first posted
- 2018-05-01
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 Pain Intensity Score Before and After Last Dose. | 2 hrs | Pain intensity is measured on the numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The difference in pain score is calculated by subtracting the average score 2 hours after pain medication is taken from the average pain score immediately before the pain medication is taken. |
| Secondary | Overall Satisfaction With the Pain Medicine | 24 hrs | Overall satisfaction with the oral opioid pain medication at 24 hours after discharge using a Likert scale. Patients will be asked to describe their overall experience as being very satisfied, satisfied, unsatisfied or very unsatisfied with the study medication. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in Pain Intensity Score Before and After Last Dose. | 2 hrs | units on a scale | MEAN | |
| SECONDARY | Overall Satisfaction With the Pain Medicine | 24 hrs | Any number analyzed that does not equal the overall number of participants is due to missing data | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | 50% or Greater Decrease in Numerical Rating Scale (NRS) Pain Score | 2 hours | Participants | COUNT_OF_PARTICIPANTS | |
| POST_HOC | Time to Follow up | up to 48 hours | hours | MEDIAN |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference in Pain Intensity Score Before and After Last Dose. | Hydrocodone (First Trial) | before most recent dose | 7.6 | Standard Deviation 1.7 | units on a scale |
| Difference in Pain Intensity Score Before and After Last Dose. | Codeine (First Trial) | before most recent dose | 7.6 | Standard Deviation 1.8 | units on a scale |
| Difference in Pain Intensity Score Before and After Last Dose. | Oxycodone (for Second Trial) | before most recent dose | 7.9 | Standard Deviation 1.5 | units on a scale |
| Difference in Pain Intensity Score Before and After Last Dose. | Codeine (for Second Trial) | before most recent dose | 7.9 | Standard Deviation 1.7 | units on a scale |
| Difference in Pain Intensity Score Before and After Last Dose. | Oxycodone (Third Trial) | before most recent dose | 7.8 | Standard Deviation 1.5 | units on a scale |
| Difference in Pain Intensity Score Before and After Last Dose. | Hydrocodone (Third Trial) | before most recent dose | 7.6 | Standard Deviation 1.6 | units on a scale |
| Difference in Pain Intensity Score Before and After Last Dose. | Hydrocodone (First Trial) | 2 hours after most recent dose | 3.6 | Standard Deviation 2.8 | units on a scale |
| Difference in Pain Intensity Score Before and After Last Dose. | Codeine (First Trial) | 2 hours after most recent dose | 4.1 | Standard Deviation 2.9 | units on a scale |
| Difference in Pain Intensity Score Before and After Last Dose. | Oxycodone (for Second Trial) | 2 hours after most recent dose | 3.4 | Standard Deviation 2.5 | units on a scale |
| Difference in Pain Intensity Score Before and After Last Dose. | Codeine (for Second Trial) | 2 hours after most recent dose | 3.6 | Standard Deviation 4.2 | units on a scale |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hydrocodone (First Trial) | 120 | |
| Overall Study | STARTED | Codeine (First Trial) | 120 | |
| Overall Study | STARTED | Oxycodone (for Second Trial) | 120 | |
| Overall Study | STARTED | Codeine (for Second Trial) | 120 | |
| Overall Study | STARTED | Oxycodone (Third Trial) | 120 | |
| Overall Study | STARTED | Hydrocodone (Third Trial) | 120 | |
| Overall Study | COMPLETED | Hydrocodone (First Trial) | 120 | |
| Overall Study | COMPLETED | Codeine (First Trial) | 120 | |
| Overall Study | COMPLETED | Oxycodone (for Second Trial) | 120 | |
| Overall Study | COMPLETED | Codeine (for Second Trial) | 120 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Hydrocodone (First Trial) | 9 | 87 | |
| other | Nausea | Gastrointestinal disorders | Codeine (First Trial) | 9 | 92 | |
| other | Nausea | Gastrointestinal disorders | Oxycodone (for Second Trial) | 13 | 111 | |
| other | Nausea | Gastrointestinal disorders | Codeine (for Second Trial) | 12 | 104 | |
| other | Nausea | Gastrointestinal disorders | Oxycodone (Third Trial) | 18 | 105 | |
| other | Nausea | Gastrointestinal disorders | Hydrocodone (Third Trial) | 8 | 112 | |
| other | Vomiting | Gastrointestinal disorders | Hydrocodone (First Trial) | 2 | 87 | |
| other | Vomiting | Gastrointestinal disorders | Codeine (First Trial) | 1 | 92 | |
| other | Vomiting | Gastrointestinal disorders | Oxycodone (for Second Trial) | 4 | 111 | |
| other | Vomiting | Gastrointestinal disorders | Codeine (for Second Trial) | 2 | 104 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydrocodone (First Trial) | 0 | 88 |
| Total, all-cause mortality | Codeine (First Trial) | 0 | 93 |
| Total, all-cause mortality | Oxycodone (for Second Trial) | 0 | 111 |
| Total, all-cause mortality | Codeine (for Second Trial) | 0 | 104 |
| Total, all-cause mortality | Oxycodone (Third Trial) | 0 | 107 |
| Total, all-cause mortality | Hydrocodone (Third Trial) | 0 | 113 |
| Total, other adverse events | Hydrocodone (First Trial) | 54 | 88 |
| Total, other adverse events | Codeine (First Trial) | 51 | 93 |
| Total, other adverse events | Oxycodone (for Second Trial) | 68 | 111 |
| Total, other adverse events | Codeine (for Second Trial) | 61 | 104 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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/NCT01402375
GET https://conductscience.org/api/trials/v1/NCT01402375/results?page=2