Pain, Postoperative, Tonsillar Hypertrophy, Tonsillitis
Conditions
Brief summary
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.
Interventions
DRUGAlternating Acetaminophen and Ibuprofen
Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
DRUGCombined Acetaminophen and Ibuprofen
Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label
Intervention model description
Single-center, randomized, open-label, non-inferiority treatment pilot study
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 4 to 17 years of age at time of enrollment * Undergoing tonsillectomy with or without adenoidectomy * Able to provide informed consent from parent or legal guardian * Able to provide assent if subject is a minor of appropriate age
Exclusion criteria
* Allergy to acetaminophen or ibuprofen * Inability for study participant to cooperate with pain assessments * Known pregnancy * Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3 | up to 3 days following consent | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7 | up to 7 days following consent | 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. |
| Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7 | 3 separate individual days, will be completed days after the surgery | 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. |
| Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7 | up to 7 days following consent | 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. |
| Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7 | 3 separate individual days, will be completed days after the surgery | 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. |
| Number of Participants With Rescue Medication Usage Through POD 7 | up to 7 days following consent | The proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens. |
| Proportion of Subjects That Adhere to the Assigned Medication Regimen | up to 3 days following consent | 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. |
| Adverse Events | up to 7 days following consent | Incidence of adverse events |
| Number of Participants With Rescue Medication Usage Through POD 3 | up to 3 days following consent | The proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Alternating Regimen A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours. | 25 |
| Combined Regimen A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Alternating Regimen | Combined Regimen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 23 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Female | 16 Participants | 10 Participants | 26 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 3 / 25 | 3 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alternating Regimen | Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3 | 1 participants |
| Combined Regimen | Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3 | 1 participants |
Secondary
Adverse Events
Incidence of adverse events
Time frame: up to 7 days following consent
Population: Alternating regimen
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alternating Regimen | Adverse Events | 3 participants |
| Combined Regimen | Adverse Events | 3 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alternating Regimen | Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7 | 3 participants |
| Combined Regimen | Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7 | 1 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alternating Regimen | Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7 | 1 participants |
| Combined Regimen | Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7 | 1 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alternating Regimen | Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7 | 1 participants |
| Combined Regimen | Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7 | 1 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alternating Regimen | Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7 | 1 participants |
| Combined Regimen | Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7 | 1 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alternating Regimen | Number of Participants With Rescue Medication Usage Through POD 3 | 3 participants |
| Combined Regimen | Number of Participants With Rescue Medication Usage Through POD 3 | 7 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alternating Regimen | Number of Participants With Rescue Medication Usage Through POD 7 | 1 participants |
| Combined Regimen | Number of Participants With Rescue Medication Usage Through POD 7 | 0 participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alternating Regimen | Proportion of Subjects That Adhere to the Assigned Medication Regimen | 25 Participants |
| Combined Regimen | Proportion of Subjects That Adhere to the Assigned Medication Regimen | 25 Participants |