This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen (NCT01334957), a na phase 4 study. The primary outcome is To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01334957 |
| Phase | Phase 4 |
| Condition | Pain |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 300 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cumberland Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
The study asked whether a single dose of intravenous ibuprofen, administered over 5-10 minutes, could be used safely in the preemptive treatment of postoperative pain. The primary outcome focused on treatment-emergent serious adverse events during the 6 hours following the first dose. The registry also describes secondary objectives concerning the safety of multiple doses and reduction of postoperative pain.
Population
The registry lists 300 participants in a surgical surveillance trial for pain. Further eligibility details and participant characteristics are not reported in the registry record.
Intervention
Intravenous ibuprofen: a single 800 mg dose administered over 5-10 minutes during the 10 minute Treatment Period.
Comparator
There is no comparator group. The trial is listed as single-group, with allocation recorded as NA.
Primary question
How many serious adverse events occurred in the 6 hours following administration of the first dose? The primary outcome is a safety count, not a direct measure of pain relief.
Because the study has no control group, it cannot estimate a difference in outcomes between ibuprofen and another treatment or no treatment. The posted safety counts describe events in the treated group; they do not, on their own, establish whether those events were caused by the infusion. Although the study title and secondary objectives refer to efficacy or pain reduction, a numerical pain outcome or comparative efficacy result is not reported in the registry record.
3. Trial Design
This is a completed phase 4, multicenter, open-label, single-group surgical surveillance trial. The registry lists enrollment as 300. It records allocation as NA and masking as none, so the design does not include randomized assignment or blinding. The intervention is intravenous ibuprofen, and no separate control arm is listed.
The intervention description specifies a single 800 mg dose infused over 5-10 minutes during a 10 minute Treatment Period. The primary objective concerns safety after a single dose. The primary outcome is described as the incidence of treatment-emergent serious adverse events in the 6 hours following the first dose. Secondary objectives concern the safety of multiple doses given over 5-10 minutes and postoperative pain reduction. Some secondary objective descriptions repeat one another in the registry.
The study is marked completed. Its start is recorded as 2011-06 and primary completion as 2012-12. The registry names Cumberland Pharmaceuticals as sponsor. These registry entries describe the study's structure and timing; they do not provide a randomized treatment contrast or evidence of comparative benefit.
Further design details, including the eligibility criteria, clinical setting beyond the surgical surveillance description, dosing schedule for any multiple-dose assessment, and the precise analysis population, are not reported in the registry record. The record also does not report a protocol or detailed statistical plan. Consequently, the listed design supports a descriptive reading of the reported safety counts, while more detailed conclusions about how participants were followed or analyzed cannot be established from this record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Patients who met all the inclusion and none of the exclusion criteria during the Screening /Baseline Period were enrolled into the study. Subjects could not have a history of allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or NSAIDS.
Overall Study
| Stage | Intravenous Ibuprofen |
|---|---|
| STARTED | 300 |
| Received Single Dose | 252 |
| Received Multiple Doses | 48 |
| COMPLETED | 300 |
| NOT COMPLETED | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Formal sample size calculations were not performed. The intent is to enroll 300 patients to provide descriptive safety and efficacy data.
| Characteristic | Unit | Intravenous Ibuprofen |
|---|---|---|
| Participants analysed | 300 | |
| Age, Customized: Greater than or equal to 18 years of age | years | 300 |
| Sex: Female, Male: Female | Participants | 189 |
| Sex: Female, Male: Male | Participants | 111 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 29 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 271 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 5 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 60 |
| Race (NIH/OMB): White | Participants | 229 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 5 |
| Region of Enrollment: United States | participants | 300 |
6. Primary Endpoint
The registry lists the primary outcome as To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain., measured over 6 hours.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Number of Serious Adverse Events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of treatment-emergent serious adverse events occurring in the 6 hours following administration of the first dose of intravenous ibuprofen. Its stated unit is number of serious adverse events, and its timeframe is 6 hours. This is a safety endpoint: it is intended to describe serious events observed during a defined period after treatment, rather than the amount of pain relief.
Counting serious events can help characterize the safety experience in a treated group. The accompanying at-risk count gives context for the number affected. However, an event count is not by itself a causal assessment. In a single-group study, events may occur for reasons other than the intervention, and without a comparator their frequency cannot be contrasted with what would have happened under another treatment or no treatment.
The registry's primary outcome description specifies the six-hour interval, but the posted safety figures do not separately identify a six-hour primary-endpoint result. The record gives an overall serious adverse event count for the group, without clarifying in that count whether it is restricted to the primary timeframe. A distinct result for the primary endpoint and further detail about how event seriousness or treatment emergence was assessed are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry lists 300 participants at risk for serious adverse events in the intravenous ibuprofen group, with 8 affected. It also lists 300 at risk for other adverse events, with 49 affected. These are descriptive counts from the treated group. They do not estimate a treatment-versus-control difference because the study has no comparator arm.
The primary outcome is specifically serious adverse events in the 6 hours after the first dose. Although the record describes this endpoint, the posted adverse-event figures do not present a separate count explicitly tied to that six-hour window. It is therefore important not to assume that the overall serious adverse event count is identical to the primary outcome result. A separately identified result for the primary timeframe is not reported in the registry record.
The registry lists six serious-event terms, each with a reported frequency of 0.3%: Abdominal Compartment Syndrome, Peritoneal Adhesions, Bile Duct Stone, Airway Complication Of Anaesthesia, Oxygen Saturation Decreased, and Pneumothorax. These are listed terms, not comparative estimates. The record does not report whether they represent all serious events, whether participants could contribute more than one term, or how the terms relate to the affected-participant count.
No inferential analysis is listed: the number of analyses is 0. The record therefore does not report a confidence interval, p-value, adjusted estimate, or formal comparison for these outcomes. Without such information, the precision of the event counts and their relationship to an underlying event frequency cannot be assessed through the registry record alone. This does not mean that a particular statistical method was or was not used outside the record; it means the method and its results are not reported in the registry record.
The study's objectives include pain reduction, but a pain result is not reported in the registry record. The safety counts cannot answer whether pain was reduced, nor do they establish how safety compares with another dosing duration or treatment. The appropriate reading is limited: the record describes adverse-event counts in a single group exposed to a shortened infusion, while comparative safety and efficacy remain unassessed by a control-group contrast in the posted information.
9. Statistical Methods Explained
The design determines what kinds of statistical conclusions are possible. This trial is listed as single-group, with allocation recorded as NA and masking as none. There is no concurrent comparison group. As a result, the posted data can describe the treated group but cannot directly estimate how its outcomes differ from those under another intervention or no intervention. Any difference from an external population would require information and assumptions not reported in the registry record.
What does a single-group count describe?
A count reports how many events or participants were recorded, while an at-risk count identifies the group in which those events were assessed. Here, the serious adverse event figures are 8 affected among 300 at risk, and the other adverse event figures are 49 affected among 300 at risk. The registry gives these counts but does not report a comparative estimate or uncertainty interval. Counts are useful for describing the observed safety experience, but they should not be read as proof that the intervention caused or prevented an event.
Event counts and participant counts are not always interchangeable. One participant can potentially have more than one event, depending on the reporting rules. The registry lists affected counts and several serious-event terms but does not explain whether individual participants could appear under multiple terms or how event episodes were counted. The terms should therefore be read as the listed categories, not used to reconstruct additional totals.
Why does the endpoint timeframe matter?
A time window defines which events are included in an outcome. The primary endpoint description specifies the 6 hours following administration of the first dose. A broader adverse-event summary may cover a different period. Since the posted safety group counts are not explicitly separated by the primary endpoint's timeframe, they should not automatically be treated as the exact six-hour result. A clearly time-matched primary outcome result is not reported in the registry record.
What would uncertainty estimates add?
In general, a confidence interval expresses the range of values reasonably compatible with the observed data under a specified statistical method. It helps distinguish a relatively precise estimate from one with substantial uncertainty. For a single-group event frequency, an interval would describe uncertainty around that group's event frequency, but it would not create a comparison or remove the limitations of the design. No confidence interval or method for deriving one is reported in the registry record.
Likewise, a p-value assesses data in relation to a specified statistical hypothesis and model. It does not measure clinical importance or establish causation. Since the record lists 0 analyses, it does not provide a p-value or specify a hypothesis test for the safety counts. A statistical test should not be inferred from the existence of counts alone.
How should the listed planning concepts be read?
In general, sample-size calculations can illustrate how many participants might be needed under stated assumptions about an effect, significance level, allocation, and analysis method. Such planning illustrations are not observed power, and they do not show that a completed study had a particular probability of detecting an effect. The registry record does not report the trial's own sample-size justification, nor does it report a planned effect size or a design calculation. Any retrospective illustration based on an observed effect would be distinct from the original design rationale; it cannot substitute for a protocol-based justification.
Over-dispersion is a general issue for count outcomes: counts can vary more widely than a simple model assumes, potentially making standard errors and intervals too small if the model fails to account for that extra variation. This trial's registry record does not report a count model, dispersion estimate, or inferential analysis. It is therefore not possible to assess whether over-dispersion was examined or whether it affected any conclusions.
Finally, the study title and objectives use language about safety and efficacy, but statistical interpretation depends on the actual outcome definitions and reported results. The primary outcome is a serious adverse event count, while no numerical pain-reduction result or efficacy comparison is reported in the registry record. The objective language alone does not constitute evidence of an effect or identify a statistical method.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 5 outcome measures and 0 analyses. The primary outcome concerns serious adverse events after a single dose, while the secondary objectives include multiple-dose safety and postoperative pain reduction. Some secondary objective descriptions are repeated. A list of objectives does not show how many hypotheses were formally tested or whether results were adjusted for testing multiple outcomes.
Multiplicity arises when several outcomes or comparisons are assessed: the chance of at least one apparently notable finding can increase if each is examined separately. In general, a statistical plan may specify a primary outcome, testing order, or adjustment method to address this issue. The registry record does not report a multiplicity strategy, a hierarchy for secondary outcomes, or an adjustment method. With no analyses listed, there are no reported inferential results to evaluate for multiplicity.
Missing-data handling is also not reported in the registry record. The record does not describe missing outcome observations, participant withdrawals, exclusions, imputation, or sensitivity analyses. Without this information, readers cannot determine how incomplete follow-up might have affected the reported counts or whether all participants at risk had outcome ascertainment for the same duration.
The analysis populations are not reported in the registry record. It is not specified whether the outcome summaries include all enrolled participants, only those who received treatment, or a subset meeting other criteria. The record gives the at-risk count of 300 for each adverse-event group, but that alone does not establish the analysis-set definition or follow-up completeness.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Intravenous Ibuprofen | 8 | 300 | 2.7% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Intravenous Ibuprofen | 49 of 300 |
Most frequent serious adverse event terms
| Event term | Organ system | Intravenous Ibuprofen |
|---|---|---|
| Abdominal Compartment Syndrome | Gastrointestinal disorders | 1 of 300 |
| Peritoneal Adhesions | Gastrointestinal disorders | 1 of 300 |
| Bile Duct Stone | Hepatobiliary disorders | 1 of 300 |
| Airway Complication Of Anaesthesia | Injury, poisoning and procedural complications | 1 of 300 |
| Oxygen Saturation Decreased | Investigations | 1 of 300 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 1 of 300 |
| Hypertension | Vascular disorders | 1 of 300 |
| Urinary Retention | Renal and urinary disorders | 1 of 300 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Intravenous Ibuprofen |
|---|---|---|
| Infusion Site Pain | General disorders | 34 of 300 |
| Nausea | Gastrointestinal disorders | 10 of 300 |
| Anaemia Postoperative | Injury, poisoning and procedural complications | 10 of 300 |
| Flatulence | Gastrointestinal disorders | 9 of 300 |
| Bradycardia | Cardiac disorders | 8 of 300 |
Serious events with the highest arm-level rate: abdominal compartment syndrome (0.3%), peritoneal adhesions (0.3%), bile duct stone (0.3%), airway complication of anaesthesia (0.3%), oxygen saturation decreased (0.3%).
The registry reports 8 affected among 300 at risk for serious adverse events in the intravenous ibuprofen group. For other adverse events, it reports 49 affected among 300 at risk. These figures describe the posted group counts; they are not comparisons against a control group. The registry does not report deaths in the group, so death information is not reported in the registry record.
Six serious-event terms are each listed at 0.3%: Abdominal Compartment Syndrome, Peritoneal Adhesions, Bile Duct Stone, Airway Complication Of Anaesthesia, Oxygen Saturation Decreased, and Pneumothorax. The term listing does not explain whether categories overlap at the participant level, how events were attributed, or whether these terms exhaust the serious events recorded.
The primary outcome specifies a 6-hour period after the first dose, but the safety counts are not separately labeled as results for that interval. They therefore should not be assumed to represent only events during the primary timeframe. The counts are a description of what the registry records, not a determination that the infusion caused an event or that an event would not have occurred otherwise.
12. What the Result Does, and Does Not, Mean
The result establishes that the registry records a safety experience in a single group exposed to intravenous ibuprofen administered over 5-10 minutes. The adverse-event summary lists 8 affected among 300 at risk for serious adverse events and 49 affected among 300 at risk for other adverse events. It also lists six serious-event terms, each reported at 0.3%. These registry entries describe the recorded group; they do not establish a comparative safety effect.
The study does not include a control group, and no randomized comparison is reported. Therefore, the posted information cannot determine whether the frequency of an event was higher or lower than it would have been with a different infusion time, a different treatment, or no treatment. Nor can it isolate the contribution of the intervention from other factors in a surgical setting.
The stated primary endpoint is serious adverse events during the 6 hours following the first dose. The group-level safety count is not separately identified as covering that exact interval. The record also does not report a numerical result for pain reduction, despite efficacy language in the title and secondary objectives. No conclusion about the magnitude of pain relief or comparative efficacy can be drawn from the posted counts.
These limitations do not make the event counts meaningless. Descriptive safety data can document what was recorded in a treated group and may help identify questions for further study. Their interpretation depends on outcome definitions, follow-up, event ascertainment, analysis populations, and comparison data; many of these details are not reported in the registry record. The counts should be understood as observations, not as proof of either safety or harm and not as a causal estimate.
13. Why This Trial Matters Statistically
This trial is statistically instructive because its title and objectives refer to both safety and efficacy, while its primary outcome is a safety count and its design has no comparator group. Statistical conclusions depend on the structure of the data and the outcome actually measured. A treatment objective is not itself a treatment-effect estimate, and descriptive counts do not answer comparative questions.
The primary outcome also illustrates why a timeframe must accompany an event measure. The registry defines the primary safety window as the 6 hours following the first dose, but the posted group-level adverse-event count is not separately labeled for that interval. If a summary count covers a different or unspecified period, it cannot simply be substituted for a time-bounded endpoint.
Another key issue is the distinction between safety surveillance and causal evaluation. A single-group surveillance design can record events observed after exposure. Without a comparison group, it cannot show whether the observed count differs from an appropriate counterfactual. This limitation is central to interpretation, not a flaw that can be corrected by using a more elaborate calculation on the same group counts.
The record lists 5 outcome measures and 0 analyses, with no reported inferential results. That makes it important to separate recorded observations from statistical evidence about an effect. Confidence intervals, tests, missing-data procedures, and analysis-set definitions can add important context, but those details are not reported in the registry record. The trial therefore demonstrates how to keep claims proportional to the information available: describe the observed counts, name the unanswered comparative questions, and avoid turning the study objective into a conclusion.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important design limitation is the single-group structure. Allocation is recorded as NA and there is no control arm, so the registry cannot support a direct comparison of safety or pain outcomes between shortened and longer infusion times, or between ibuprofen and another treatment. The study is open-label, with masking recorded as none; further information about outcome assessment is not reported in the registry record.
The stated primary endpoint concerns serious adverse events in the 6 hours following the first dose, but the posted serious-event count is not separately reported for that interval. The relationship between the overall group count and the specific primary timeframe is therefore unclear. Definitions of treatment-emergent events, event attribution, ascertainment procedures, and follow-up completeness are not reported in the registry record.
The record reports 300 at risk for each adverse-event category, but does not provide analysis-population definitions or missing-data methods. It does not report participant characteristics or detailed eligibility criteria, which limits assessment of how broadly the observed counts may apply. The serious-event term list also does not explain overlap among terms or the relationship between terms and affected participants.
No statistical analyses are listed. A confidence interval, p-value, adjusted estimate, multiplicity plan, interim analysis, and sample-size justification are not reported in the registry record. Finally, numerical pain outcomes are absent despite pain-related secondary objectives. These omissions limit both precision assessment and interpretation of efficacy; they should not be filled by assumptions about the protocol or analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen — NCT01334957.
- Registry record last updated 2024-02-28; status last verified 2024-02.
- Results first posted 2014-06-23.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT01334957 is a completed phase 4, multicenter, open-label, single-group surgical surveillance trial sponsored by Cumberland Pharmaceuticals. The registry lists enrollment as 300 and describes a single 800 mg dose of intravenous ibuprofen administered over 5-10 minutes during a 10 minute Treatment Period. The primary objective concerns serious adverse events during the 6 hours following the first dose.
The adverse-event summary lists 8 affected among 300 at risk for serious adverse events and 49 affected among 300 at risk for other adverse events. Six serious-event terms are each reported at 0.3%. The record lists 5 outcome measures and 0 analyses. It does not report a comparator, numerical pain-reduction result, inferential analysis, or a distinct six-hour result for the primary endpoint. The posted counts should therefore be read as descriptive safety information, not as comparative or causal estimates.