Trial · NCT00598702
Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients
NCT00598702, Phase 3, Completed, Mallinckrodt; results first posted 2011-01-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients. Trials, record NCT00598702. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00598702
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients
- NCT number
- NCT00598702
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 100 participants, actual
- Lead sponsor
- Mallinckrodt
- Conditions
- Pain, Fever
- Interventions
- IV Acetaminophen
- First posted
- 2008-01-22
- Last updated
- 2017-05-10
- Results first posted
- 2011-01-06
- Limitations and caveats
The original protocol required 50 subjects that completed 5 days of treatment. With protocol amendment 2, the criteria for enrollment/completion was reduced to 1 day of treatment. Subjects were required to have a minimum of 3 IV APAP doses per day.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) | First dose to end of treatment period | A TEAE is defined as an adverse event that starts on or after the start of study medication. |
| Primary | Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event | First dose to 30 days after last dose | A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP that; * results in death * is life-threatening * requires inpatient hospitalization or causes prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event |
| Secondary | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Day 0 to Day 5, Day 7 or Early Termination from study | Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent). |
| Secondary | Physician's Global Assessment of Study Treatment | End of study or Early Termination | Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Day 0 to Day 5, Day 7 or Early Termination from study | All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication. | participants | NUMBER |
| PRIMARY | Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) | First dose to end of treatment period | All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication. | Subjects | NUMBER |
| SECONDARY | Physician's Global Assessment of Study Treatment | End of study or Early Termination | All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication. | participants | NUMBER |
| PRIMARY | Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event | First dose to 30 days after last dose | All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication. | Subjects | NUMBER |
Source ClinicalTrials.gov
Results by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Poor | 0 | participants | |
| Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Poor | 0 | participants | |
| Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | Poor | 0 | participants | |
| Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | Poor | 0 | participants | |
| Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | Poor | 0 | participants | |
| Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | Poor | 0 | participants | |
| Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | Poor | 0 | participants | |
| Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | Poor | 0 | participants | |
| Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | Fair | 0 | participants | |
| Subject's (Parent/Guardian) Global Evaluation of Study Treatment | Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | Fair | 0 | participants |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | 1 | |
| Overall Study | STARTED | Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | 3 | |
| Overall Study | STARTED | Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | 7 | |
| Overall Study | STARTED | Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | 33 | |
| Overall Study | STARTED | Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | 9 | |
| Overall Study | STARTED | Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | 42 | |
| Overall Study | STARTED | Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | 1 | |
| Overall Study | STARTED | Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | 4 | |
| Overall Study | COMPLETED | Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | 1 | |
| Overall Study | COMPLETED | Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events568
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 | Abdominal abscess | Infections and infestations | Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | 0 | 1 | |
| other | Abdominal abscess | Infections and infestations | Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | 0 | 3 | |
| other | Abdominal abscess | Infections and infestations | Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | 0 | 7 | |
| other | Abdominal abscess | Infections and infestations | Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | 0 | 33 | |
| other | Abdominal abscess | Infections and infestations | Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | 0 | 9 | |
| other | Abdominal abscess | Infections and infestations | Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | 0 | 42 | |
| other | Abdominal abscess | Infections and infestations | Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | 0 | 1 | |
| other | Abdominal abscess | Infections and infestations | Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | 1 | 4 | |
| other | Agitation | Psychiatric disorders | Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | 0 | 1 | |
| other | Agitation | Psychiatric disorders | Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | 0 | 3 |
1 to 10 of 568Source ClinicalTrials.gov
See all 568 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | ||
| Total, all-cause mortality | Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | ||
| Total, all-cause mortality | Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h | ||
| Total, all-cause mortality | Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h | ||
| Total, all-cause mortality | Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h | ||
| Total, all-cause mortality | Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h | ||
| Total, all-cause mortality | Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h | ||
| Total, all-cause mortality | Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h | ||
| Total, other adverse events | Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h | 1 | 1 |
| Total, other adverse events | Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h | 1 | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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/NCT00598702
GET https://conductscience.org/api/trials/v1/NCT00598702/results?page=2