Perforated Appendicitis
Conditions
Keywords
appendicitis, pain, perforation
Brief summary
The objective of this study is to evaluate two standard post-operative pain regimens routinely used after laparoscopic appendectomy for perforated appendicitis. The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off patient/nurse controlled analgesia (PCA) to oral pain medications.
Detailed description
To assess pain control, patient and family perception of pain control, time to return of bowel function defined as passage of first flatus (in days), doses of anti-emetic medications, doses of narcotic pain medications, time to toleration of regular diet (in days), narcotic associated adverse effects (nausea, emesis, respiratory depression, constipation), length of stay, and overall hospital cost in admission. Post-hospitalization the investigators will assess complications including number and reasons for emergency visits and abscess formation, length of post-hospitalization analgesic use, length of post-hospitalization narcotic use, and time to return to school.
Interventions
DRUGIV tylenol
IV tylenol given scheduled in addition to standard PCA
DRUGNo IV tylenol
No additional IV Tylenol given
DRUGKetorolac
both groups receive as part of our standard postop pain protocol after all operations
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* All patients ages 2-17 years old undergoing laparoscopic appendectomy at CMH found to have perforated appendicitis.
Exclusion criteria
* Non-perforated appendicitis * Normal appendix at the time of operation or other associated conditions causing abdominal pain * Patients with history of chronic pain * Known underlying liver disorders * Known allergy to pain medication in protocol * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Until PCA Discontinued After the Operation | 4 days | The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off PCA/NCA to oral pain medications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Duration of Hospital Stay | 1 week | The investigators will measure postoperative time to discharge |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Tylenol Post-operatively, all patients will be placed on a standard patient/nurse controlled analgesia (PCA) according to our pain service protocol which included ketorolac. A 3 hours after first dose of ketorolac, patients in the acetaminophen arm will then receive scheduled 10mg/kg of IV acetaminophen every 6hrs for a total of 3 days in between doses of ketorolac. PCA Pumps will be discontinued with the return of bowel function and transition to oral intake in all patients as per the current protocol. If a patient in the acetaminophen arm is transitioned off of PCA prior to 3 days, IV acetaminophen will be stopped at that time as well. Patients in the control group only may receive oral/rectal acetaminophen as needed for treatment of fevers.
IV tylenol: IV tylenol given scheduled in addition to standard PCA
Ketorolac: both groups receive as part of our standard postop pain protocol after all operations | 39 |
| No IV Tylenol Same as above without IV tylenol.
No IV tylenol: No additional IV Tylenol given
Ketorolac: both groups receive as part of our standard postop pain protocol after all operations | 43 |
| Total | 82 |
Baseline characteristics
| Characteristic | No IV Tylenol | Total | IV Tylenol |
|---|---|---|---|
| Age, Categorical <=18 years | 43 Participants | 82 Participants | 39 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 | 9.6 years | 10.25 years | 10.9 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 43 participants | 82 participants | 39 participants |
| Sex: Female, Male Female | 13 Participants | 27 Participants | 14 Participants |
| Sex: Female, Male Male | 30 Participants | 55 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 43 |
| other Total, other adverse events | 0 / 39 | 0 / 43 |
| serious Total, serious adverse events | 0 / 39 | 0 / 43 |
Outcome results
Primary
Time Until PCA Discontinued After the Operation
The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off PCA/NCA to oral pain medications.
Time frame: 4 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IV Tylenol | Time Until PCA Discontinued After the Operation | 76.4 hours |
| No IV Tylenol | Time Until PCA Discontinued After the Operation | 86.7 hours |
Secondary
Postoperative Duration of Hospital Stay
The investigators will measure postoperative time to discharge
Time frame: 1 week
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IV Tylenol | Postoperative Duration of Hospital Stay | 3.9 days |
| No IV Tylenol | Postoperative Duration of Hospital Stay | 4.5 days |