Trial · NCT02647788
Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery
NCT02647788, Phase 4, Completed, University of Pennsylvania; results first posted 2019-02-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery. Trials, record NCT02647788. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02647788
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery
- NCT number
- NCT02647788
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 144 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Pain, Postoperative
- Interventions
- Acetaminophen/Ibuprofen, Acetaminophen/Codeine
- First posted
- 2016-01-06
- Last updated
- 2019-02-18
- Results first posted
- 2019-02-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | Subjects reported pain 3 times a day each day after hand surgery (at dinner time, before going to sleep and in the middle of the night), until post-op appointment (between 4 and 8 days after surgery). The numbers reported are the average daily pain scores | To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen). The pain VAS is a continuous scale where 0=no pain and 10=worst pain imaginable. |
| Secondary | Quality of Recovery-9 (QoR-9). | Postoperative Day 2 | To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction through Quality of Recovery (QoR) scores in ambulatory hand surgery. This 9 question survey has a maximum score (best outcome) of 18 and minimum (worst outcome) of 3. The survey was administered over the phone on post-operative day 2. |
| Secondary | Number of Pills Used | From the time of surgery to first clinic visit (post-op day 6 to 8) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | Subjects reported pain 3 times a day each day after hand surgery (at dinner time, before going to sleep and in the middle of the night), until post-op appointment (between 4 and 8 days after surgery). The numbers reported are the average daily pain scores | 111 patients completed the study and their data was included in the analysis | score on a scale | MEAN |
| SECONDARY | Quality of Recovery-9 (QoR-9). | Postoperative Day 2 | Of the 111 subjects that completed the study, QoR score was available for 93 participants. | Scores on a scale | MEAN |
| SECONDARY | Number of Pills Used | From the time of surgery to first clinic visit (post-op day 6 to 8) | Of the 111 subjects that completed the study, data about how many capsules were used was available for 100 participants. | Pills | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | Acetaminophen/Ibuprofen | VAS Pain Day 1 | 2.90 | Standard Deviation 2.22 | score on a scale |
| Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | Acetaminophen/Codeine | VAS Pain Day 1 | 3.51 | Standard Deviation 2.69 | score on a scale |
| Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | Acetaminophen/Ibuprofen | VAS Pain Day 2 | 2.36 | Standard Deviation 2.31 | score on a scale |
| Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | Acetaminophen/Codeine | VAS Pain Day 2 | 2.40 | Standard Deviation 2.52 | score on a scale |
| Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | Acetaminophen/Ibuprofen | VAS Pain Day 3 | 1.69 | Standard Deviation 2.00 | score on a scale |
| Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | Acetaminophen/Codeine | VAS Pain Day 3 | 2.26 | Standard Deviation 2.38 | score on a scale |
| Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | Acetaminophen/Ibuprofen | VAS Pain Day 4 | 1.47 | Standard Deviation 1.82 | score on a scale |
| Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | Acetaminophen/Codeine | VAS Pain Day 4 | 1.93 | Standard Deviation 2.01 | score on a scale |
| Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | Acetaminophen/Ibuprofen | VAS Pain Day 5 | 1.23 | Standard Deviation 1.61 | score on a scale |
| Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score | Acetaminophen/Codeine | VAS Pain Day 5 | 1.48 | Standard Deviation 1.48 | score on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acetaminophen/Ibuprofen | 70 | |
| Overall Study | STARTED | Acetaminophen/Codeine | 70 | |
| Overall Study | COMPLETED | Acetaminophen/Ibuprofen | 54 | |
| Overall Study | COMPLETED | Acetaminophen/Codeine | 57 | |
| Overall Study | NOT COMPLETED | Acetaminophen/Ibuprofen | 16 | |
| Overall Study | NOT COMPLETED | Acetaminophen/Codeine | 13 |
Source ClinicalTrials.gov
Adverse events10
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 | General disorders | Acetaminophen/Ibuprofen | 8 | 70 | |
| other | Nausea | General disorders | Acetaminophen/Codeine | 7 | 70 | |
| other | Constipation | General disorders | Acetaminophen/Ibuprofen | 8 | 70 | |
| other | Constipation | General disorders | Acetaminophen/Codeine | 12 | 70 | |
| other | Itchiness | General disorders | Acetaminophen/Ibuprofen | 12 | 70 | |
| other | Itchiness | General disorders | Acetaminophen/Codeine | 11 | 70 | |
| other | Dizziness | General disorders | Acetaminophen/Ibuprofen | 3 | 70 | |
| other | Dizziness | General disorders | Acetaminophen/Codeine | 2 | 70 | |
| other | Drowsiness | General disorders | Acetaminophen/Ibuprofen | 22 | 70 | |
| other | Drowsiness | General disorders | Acetaminophen/Codeine | 10 | 70 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acetaminophen/Ibuprofen | 0 | 70 |
| Total, all-cause mortality | Acetaminophen/Codeine | 0 | 70 |
| Total, other adverse events | Acetaminophen/Ibuprofen | 32 | 70 |
| Total, other adverse events | Acetaminophen/Codeine | 30 | 70 |
| Total, serious adverse events | Acetaminophen/Ibuprofen | 0 | 70 |
| Total, serious adverse events | Acetaminophen/Codeine | 0 | 70 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Acetaminophen/Ibuprofen vs Acetaminophen/Codeine: deaths from any cause | Trial comparisons |
| Acetaminophen/Ibuprofen vs Acetaminophen/Codeine: serious adverse events | Trial comparisons |
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/NCT02647788
GET https://conductscience.org/api/trials/v1/NCT02647788/registered