A Phase 3 interventional study of Alternating Acetaminophen and Ibuprofen and Combined Acetaminophen and Ibuprofen in Pain, Postoperative, Tonsillar Hypertrophy and Tonsillitis, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by Washington University School of Medicine · Phase 3, Interventional, and Treatment
Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 50 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Drug: Alternating Acetaminophen and Ibuprofen
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Drug: Combined Acetaminophen and Ibuprofen
Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
Also known as: Alternating regimen
Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
Also known as: Combined regimen
Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3
The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
Time frame: up to 3 days following consent
Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7
The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 on each individual POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
Time frame: 3 separate individual days, will be completed days after the surgery
Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7
The proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
Time frame: up to 7 days following consent
Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7
The proportion of Faces pain scores ≥8 on POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Time frame: 3 separate individual days, will be completed days after the surgery
Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7
The proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Time frame: up to 7 days following consent
Number of Participants With Rescue Medication Usage Through POD 3
The proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens.
Time frame: up to 3 days following consent
Number of Participants With Rescue Medication Usage Through POD 7
The proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens.
Time frame: up to 7 days following consent
Proportion of Subjects That Adhere to the Assigned Medication Regimen
Proportion of subjects that adhere to the assigned medication regimen compared between the combined and the alternating medication regimens as determined by the medication log that the participants return at the end of the study.
Time frame: up to 3 days following consent
Adverse Events
Incidence of adverse events
Time frame: up to 7 days following consent
Eligible candidates scheduled to undergo tonsillectomy at SLCH were approached either in the outpatient setting or preoperative holding area prior to surgery by the study team. Recruitment period was from 3/2020 - 10/2021.
| Milestone | Alternating Regimen | Combined Regimen |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
| participants | Alternating Regimen | Combined Regimen |
|---|---|---|
| Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3 | 1 | 1 |
The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 on each individual POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
| participants | Alternating Regimen | Combined Regimen |
|---|---|---|
| Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7 | 1 | 1 |
The proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
| participants | Alternating Regimen | Combined Regimen |
|---|---|---|
| Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7 | 1 | 1 |
The proportion of Faces pain scores ≥8 on POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
| participants | Alternating Regimen | Combined Regimen |
|---|---|---|
| Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7 | 1 | 1 |
The proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
| participants | Alternating Regimen | Combined Regimen |
|---|---|---|
| Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7 | 3 | 1 |
The proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens.
| participants | Alternating Regimen | Combined Regimen |
|---|---|---|
| Number of Participants With Rescue Medication Usage Through POD 3 | 3 | 7 |
The proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens.
| participants | Alternating Regimen | Combined Regimen |
|---|---|---|
| Number of Participants With Rescue Medication Usage Through POD 7 | 1 | 0 |
Proportion of subjects that adhere to the assigned medication regimen compared between the combined and the alternating medication regimens as determined by the medication log that the participants return at the end of the study.
| Participants | Alternating Regimen | Combined Regimen |
|---|---|---|
| Proportion of Subjects That Adhere to the Assigned Medication Regimen | 25 | 25 |
Incidence of adverse events
| participants | Alternating Regimen | Combined Regimen |
|---|---|---|
| Adverse Events | 3 | 3 |
Collected over Adverse event data was collected post operatively days 1 through 7. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alternating Regimen | 0/25 (0%) | 0/25 (0%) | 3/25 (12%) |
| Combined Regimen | 0/25 (0%) | 0/25 (0%) | 3/25 (12%) |
| Event | Alternating Regimen | Combined Regimen |
|---|---|---|
| EmesisGastrointestinal disorders | 3/25 | 1/25 |
| NauseaGastrointestinal disorders | 2/25 | 1/25 |
| Bloody Oral SecretionsGastrointestinal disorders | 0/25 | 1/25 |
| Pain - UncontrolledGeneral disorders | 1/25 | 1/25 |
| Age, Categorical(Participants) | Alternating Regimen | Combined Regimen | Total |
|---|---|---|---|
| <=18 years | 25 | 25 | 50 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Alternating Regimen | Combined Regimen | Total |
|---|---|---|---|
| Female | 16 | 10 | 26 |
| Male | 9 | 15 | 24 |
| Ethnicity (NIH/OMB)(Participants) | Alternating Regimen | Combined Regimen | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 25 | 23 | 48 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Alternating Regimen | Combined Regimen | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 4 | 8 |
| White | 21 | 20 | 41 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
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