Trial · NCT01267136
A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy
NCT01267136, Phase 4, Completed, Children's Hospitals and Clinics of Minnesota; results first posted 2014-04-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy. Trials, record NCT01267136. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01267136
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy
- NCT number
- NCT01267136
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 84 participants, actual
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Conditions
- Tonsillitis, Pain
- Interventions
- Codeine with acetaminophen, Tramadol suspension
- First posted
- 2010-12-28
- Last updated
- 2014-04-17
- Results first posted
- 2014-04-17
- Limitations and caveats
- There was insufficient power to detect differences in safety.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period. | Efficacy was assessed daily during the 10-day postoperative recovery period. | Average number of post-operative days with pain score \>4/10. Pain score assessments were administered once daily by parents using either the Numeric Rating Scale (NRS-11) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 8-15 (von Baeyer et al., 2009) or the Faces Pain Scale-Revised (FPS-R) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 4-10 (Hicks et al., 2001). |
| Secondary | Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period. | Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary. | Parent-reported side effects entered in 10-day diary. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period. | Efficacy was assessed daily during the 10-day postoperative recovery period. | days | MEDIAN | |
| SECONDARY | Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period. | Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period. | Capital® With Codeine Suspension | 1.5 | Full Range 0 to 9 | days | |
| Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period. | Tramadol Suspension | 1 | Full Range 0 to 9 | days | |
| Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period. | Capital® With Codeine Suspension | Nausea | 20 | participants | |
| Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period. | Tramadol Suspension | Nausea | 20 | participants | |
| Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period. | Capital® With Codeine Suspension | Vomiting | 21 | participants | |
| Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period. | Tramadol Suspension | Vomiting | 18 | participants | |
| Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period. | Capital® With Codeine Suspension | Fever | 11 | participants | |
| Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period. | Tramadol Suspension | Fever | 10 | participants | |
| Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period. | Capital® With Codeine Suspension | Itching | 5 | participants | |
| Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period. | Tramadol Suspension | Itching | 12 | participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Capital® With Codeine Suspension | 42 | |
| Overall Study | STARTED | Tramadol Suspension | 42 | |
| Overall Study | COMPLETED | Capital® With Codeine Suspension | 38 | |
| Overall Study | COMPLETED | Tramadol Suspension | 36 | |
| Overall Study | NOT COMPLETED | Capital® With Codeine Suspension | 4 | |
| Overall Study | NOT COMPLETED | Tramadol Suspension | 6 |
Source ClinicalTrials.gov
Adverse events30
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 | Nervous system disorders | Capital® With Codeine Suspension | 20 | 38 | |
| other | Nausea | Nervous system disorders | Tramadol Suspension | 20 | 36 | |
| other | Vomiting | Gastrointestinal disorders | Capital® With Codeine Suspension | 21 | 38 | |
| other | Vomiting | Gastrointestinal disorders | Tramadol Suspension | 18 | 36 | |
| other | Fever | Infections and infestations | Capital® With Codeine Suspension | 11 | 38 | |
| other | Fever | Infections and infestations | Tramadol Suspension | 10 | 36 | |
| other | Itching | Skin and subcutaneous tissue disorders | Capital® With Codeine Suspension | 5 | 38 | |
| other | Itching | Skin and subcutaneous tissue disorders | Tramadol Suspension | 12 | 36 | |
| other | Rash | Skin and subcutaneous tissue disorders | Capital® With Codeine Suspension | 1 | 38 | |
| other | Rash | Skin and subcutaneous tissue disorders | Tramadol Suspension | 1 | 36 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Capital® With Codeine Suspension | ||
| Total, all-cause mortality | Tramadol Suspension | ||
| Total, other adverse events | Capital® With Codeine Suspension | 33 | 38 |
| Total, other adverse events | Tramadol Suspension | 35 | 36 |
| Total, serious adverse events | Capital® With Codeine Suspension | 1 | 42 |
| Total, serious adverse events | Tramadol Suspension | 1 | 42 |
Source ClinicalTrials.gov
Papers28
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Capital® With Codeine Suspension vs Tramadol Suspension: serious 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.
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/NCT01267136
GET https://conductscience.org/api/trials/v1/NCT01267136/results?page=2