Pyloric Stenosis
Conditions
Brief summary
This is a retrospective chart review. The objective of the current study is to determine the analgesic efficacy and side effect profile of intravenous acetaminophen when administered to infants undergoing pyloromyotomy. In addition, recovery characteristics of infants who were administered intravenous acetaminophen will be compared to infants who did not receive intravenous acetaminophen to determine if there were any appreciable differences with regard to postoperative discomfort, PACU time, time to oral feeds and hospital discharge.
Interventions
DRUGAcetaminophen
Acetaminophen given by IV
Sponsors
Arlyne Thung
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* patients who presented for pyloromyotomy
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acetaminophen Dosage | Baseline | One time in the OR prior to the start of surgery |
| Average FLACC Pain Score in the PACU | 0-60 minutes post-operatively | The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PACU Time | 45-60 minutes post-operatively | Time spent in the post-anesthesia care unit post-operatively. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Acetaminophen Acetaminophen administered by intravenous infusion. | 34 |
| Rectal Acetaminophen Acetaminophen administered by rectal suppository. | 34 |
| Total | 68 |
Baseline characteristics
| Characteristic | Rectal Acetaminophen | IV Acetaminophen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 34 Participants | 34 Participants | 68 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 37.8 days STANDARD_DEVIATION 16.5 | 34.2 days STANDARD_DEVIATION 14.5 | 36 days STANDARD_DEVIATION 15.5 |
| Region of Enrollment United States | 34 participants | 34 participants | 68 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 29 Participants | 29 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
Acetaminophen Dosage
One time in the OR prior to the start of surgery
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen | Acetaminophen Dosage | 8.6 mg/kg | Standard Deviation 3.9 |
| Rectal Acetaminophen | Acetaminophen Dosage | 30.7 mg/kg | Standard Deviation 6.3 |
Primary
Average FLACC Pain Score in the PACU
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain.
Time frame: 0-60 minutes post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen | Average FLACC Pain Score in the PACU | 0.3 units on a scale 0-10 | Standard Deviation 0.6 |
| Rectal Acetaminophen | Average FLACC Pain Score in the PACU | 0.6 units on a scale 0-10 | Standard Deviation 1 |
Secondary
PACU Time
Time spent in the post-anesthesia care unit post-operatively.
Time frame: 45-60 minutes post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Acetaminophen | PACU Time | 48 minutes | Standard Deviation 19.9 |
| Rectal Acetaminophen | PACU Time | 50.4 minutes | Standard Deviation 12 |