Trial · NCT04122443

Acetaminophen (APAP) +/- Oxycodone

NCT04122443, Phase 4, Completed, Montefiore Medical Center; results first posted 2024-02-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Acetaminophen (APAP) +/- Oxycodone. Trials, record NCT04122443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04122443

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Acetaminophen (APAP) +/- Oxycodone
NCT number: NCT04122443
Status: Completed
Phases: Phase 4
Enrollment: 393 participants, actual
Lead sponsor: Montefiore Medical Center
Conditions: Musculoskeletal Pain
Interventions: Acetaminophen, Oxycodone
First posted: 2019-10-10
Last updated: 2024-02-28
Results first posted: 2024-02-28

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Pain Assessment	2 hours following treatment	Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief.
Secondary	Sustained Pain Relief	Up to 48 hours following medication administration	Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Sustained pain relief was determined using a four-item ordinal scale. The rating was verbal and the subject was asked to describe their level of pain within two hours of medication administration and maintaining this level, without rescue medication, for 48 hours. The patients used the following descriptors: severe, moderate, mild, or none. For reporting responses of 'mild' and 'none' were aggregated into a single category and 'moderate' and severe' were aggregated into a separate category.
Secondary	Adequacy of Analgesia	2 hours following treatment	Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Adequacy of analgesia was determined by querying the participants by asking a single question: "Did the medication provided control your pain?" Answer choices: Yes (it did); No (It did not); and Unsure. The number of participants responses were summarized by category.
Secondary	Satisfaction With Medication	2 hours following treatment	Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): The number of participants demonstrating satisfaction with medication was determined by asking participants if the same medication regimen would be desired during a subsequent episode of pain. Possible responses included "Yes", "No" or "Unsure"
Secondary	Medication-related Adverse Events	2 hours following treatment	Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): The number of participants demonstrating medication-related adverse events was tabulated by treatment arm/group.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Pain Assessment	2 hours following treatment		score on a scale	MEAN
SECONDARY	Sustained Pain Relief	Up to 48 hours following medication administration		participants	NUMBER
SECONDARY	Adequacy of Analgesia	2 hours following treatment	Responses for 3 participants in the 'Acetaminophen' arm and 1 participant in the 'Oxycodone + Acetaminophen' arm were unavailable.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Satisfaction With Medication	2 hours following treatment	Responses for 4 participants in the 'Acetaminophen' arm and 1 participant in the 'Oxycodone + Acetaminophen' arm were unavailable.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Medication-related Adverse Events	2 hours following treatment	Responses for 3 participants in the 'Acetaminophen' arm and 1 participant in the 'Oxycodone + Acetaminophen' arm were unavailable.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Pain Assessment	Ibuprofen and Then Acetaminophen (Stage 2)		2.9	Standard Deviation 2.4	score on a scale
Change in Pain Assessment	Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)		4.0	Standard Deviation 2.6	score on a scale
Sustained Pain Relief	Ibuprofen and Then Acetaminophen (Stage 2)	Mild/None	33		participants
Sustained Pain Relief	Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)	Mild/None	43		participants
Sustained Pain Relief	Ibuprofen and Then Acetaminophen (Stage 2)	Moderate/Severe	44		participants
Sustained Pain Relief	Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)	Moderate/Severe	34		participants
Adequacy of Analgesia	Ibuprofen and Then Acetaminophen (Stage 2)	Yes	51		Participants
Adequacy of Analgesia	Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)	Yes	59		Participants
Adequacy of Analgesia	Ibuprofen and Then Acetaminophen (Stage 2)	No	23		Participants
Adequacy of Analgesia	Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)	No	17		Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Stage 1 - Open Label	STARTED	Acetaminophen	0
Stage 1 - Open Label	STARTED	Oxycodone/Acetaminophen	0
Stage 1 - Open Label	STARTED	Ibuprofen	393
Stage 1 - Open Label	COMPLETED	Acetaminophen	0
Stage 1 - Open Label	COMPLETED	Oxycodone/Acetaminophen	0
Stage 1 - Open Label	COMPLETED	Ibuprofen	154
Stage 1 - Open Label	NOT COMPLETED	Acetaminophen	0
Stage 1 - Open Label	NOT COMPLETED	Oxycodone/Acetaminophen	0
Stage 1 - Open Label	NOT COMPLETED	Ibuprofen	239
Stage 2 - Double Blinded	STARTED	Acetaminophen	77

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events24

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
other	Dizziness	Nervous system disorders	Ibuprofen and Then Acetaminophen (Stage 2)	2	74
other	Dizziness	Nervous system disorders	Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)	6	76
other	Dizziness	Nervous system disorders	Ibuprofen (Stage 1)	0	0
other	Drowsiness	Nervous system disorders	Ibuprofen and Then Acetaminophen (Stage 2)	6	74
other	Drowsiness	Nervous system disorders	Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)	17	76
other	Drowsiness	Nervous system disorders	Ibuprofen (Stage 1)	0	0
other	Nausea	Gastrointestinal disorders	Ibuprofen and Then Acetaminophen (Stage 2)	0	74
other	Nausea	Gastrointestinal disorders	Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)	6	76
other	Nausea	Gastrointestinal disorders	Ibuprofen (Stage 1)	0	0
other	Nausea	Gastrointestinal disorders	Ibuprofen and Then Acetaminophen (Stage 2)	0	74

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ibuprofen and Then Acetaminophen (Stage 2)	0	74
Total, all-cause mortality	Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)	0	76
Total, all-cause mortality	Ibuprofen (Stage 1)	0	0
Total, other adverse events	Ibuprofen and Then Acetaminophen (Stage 2)	6	74
Total, other adverse events	Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)	18	76
Total, other adverse events	Ibuprofen (Stage 1)	0	0
Total, serious adverse events	Ibuprofen and Then Acetaminophen (Stage 2)	0	74
Total, serious adverse events	Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)	0	76
Total, serious adverse events	Ibuprofen (Stage 1)	0	0

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Ibuprofen and Then Acetaminophen (Stage 2) vs Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2): Medication-related Adverse Events

Source 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04122443

GET https://conductscience.org/api/trials/v1/NCT04122443/events?page=2

API reference For AI assistants