Trial · NCT03173456

Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED)

NCT03173456, Phase 2, Completed, Albert Einstein College of Medicine; results first posted 2022-02-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED). Trials, record NCT03173456. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03173456

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Trial

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

Title: Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED)
NCT number: NCT03173456
Status: Completed
Phases: Phase 2
Enrollment: 600 participants, actual
Lead sponsor: Albert Einstein College of Medicine
Conditions: Musculoskeletal Pain
Interventions: oxycodone/APAP, hydrocodone/APAP, codeine/APAP, 400 ibuprofen/APAP, 800 ibuprofen/APAP
First posted: 2017-06-01
Last updated: 2022-02-01
Results first posted: 2022-02-01

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline	Prior to Ingestion of study medication to one hour after ingestion of the study medication	Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10 = worse possible pain. Change calculated as NRS before medication administered (denoted as baseline) minus NRS 1-hour post-baseline. Higher scores mean more change which is the better outcome.
Secondary	Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline	Prior to ingestion of study medication to 2 hours after ingestion of the study medication	Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10=worst possible pain. Change is calculated as Numerical Rating Scale before medication is administered (denoted as baseline) minus NRS 2- hours past baseline. Higher numbers indicate better outcomes.
Secondary	Percentage of Patients Who Received Rescue Medication	Entire two-hour time period	Number of patients who received additional analgesics divided by total number of patients x 100
Secondary	Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain	End of two-hour time period	Number of patients who would choose to take study medication again divided by number of patients x 100. Question asked at end of two-hour time period
Secondary	Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication	From time of ingestion of study medication to one hour later	Number of patients who experience side effects within one hour ofr ingestion of study medication divided by total number of patients x 100
Secondary	Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication	From time of ingestion of study medication to two hours later	Number of patients who experience side effects in two hours after ingestion of study medication divided by total number of patients x 100

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline	Prior to Ingestion of study medication to one hour after ingestion of the study medication		Units on a scale	MEAN
SECONDARY	Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline	Prior to ingestion of study medication to 2 hours after ingestion of the study medication	Differences between population at 1 hour and 2 hour is due to patients leaving the Emergency Department before 2 hours post-baseline	units on a scale	MEAN
SECONDARY	Percentage of Patients Who Received Rescue Medication	Entire two-hour time period		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain	End of two-hour time period	Missing data: 1 from codeine/APAP arm, 1 from hydrocodone/APAP arm, 2 from oxycodone/APAP arm	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication	From time of ingestion of study medication to one hour later		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication	From time of ingestion of study medication to two hours later		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group30

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

Outcome	Group	Value	Spread	Units
Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline	400 Ibuprofen/APAP	3.0	95% Confidence Interval 2.6 to 3.5	Units on a scale
Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline	800 Ibuprofen/APAP	3.0	95% Confidence Interval 2.5 to 3.5	Units on a scale
Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline	Codeine/APAP	3.4	95% Confidence Interval 2.9 to 3.9	Units on a scale
Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline	Hydrocodone/APAP	3.1	95% Confidence Interval 2.7 to 3.5	Units on a scale
Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline	Oxycodone/APAP	3.3	95% Confidence Interval 2.8 to 3.7	Units on a scale
Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline	400 Ibuprofen/APAP	4.3	95% Confidence Interval 3.9 to 4.8	units on a scale
Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline	800 Ibuprofen/APAP	4.6	95% Confidence Interval 4.1 to 5.1	units on a scale
Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline	Codeine/APAP	4.4	95% Confidence Interval 3.9 to 4.9	units on a scale
Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline	Hydrocodone/APAP	4.5	95% Confidence Interval 4.1 to 5.0	units on a scale
Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline	Oxycodone/APAP	4.7	95% Confidence Interval 4.2 to 5.2	units on a scale

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow30

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

Period	Milestone	Group	Participants
Baseline	STARTED	Oxycodone/Acetaminophen (APAP)	120
Baseline	STARTED	Hydrocodone/APAP	120
Baseline	STARTED	Codeine/APAP	120
Baseline	STARTED	400 Ibuprofen/APAP	120
Baseline	STARTED	800 Ibuprofen/APAP	120
Baseline	COMPLETED	Oxycodone/Acetaminophen (APAP)	120
Baseline	COMPLETED	Hydrocodone/APAP	119
Baseline	COMPLETED	Codeine/APAP	120
Baseline	COMPLETED	400 Ibuprofen/APAP	120
Baseline	COMPLETED	800 Ibuprofen/APAP	118

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

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 totals15

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	400 Ibuprofen/APAP	120
Total, all-cause mortality	800 Ibuprofen/APAP	118
Total, all-cause mortality	Codeine/APAP	120
Total, all-cause mortality	Hydrocodone/APAP	119
Total, all-cause mortality	Oxycodone/APAP	120
Total, other adverse events	400 Ibuprofen/APAP	120
Total, other adverse events	800 Ibuprofen/APAP	118
Total, other adverse events	Codeine/APAP	120
Total, other adverse events	Hydrocodone/APAP	119
Total, other adverse events	Oxycodone/APAP	120

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33358232	DERIVED

Source PubMed

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.

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.

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