The Impact of IV Acetaminophen on Pain After Appendectomy for Perforated Appendicitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of IV Acetaminophen on Post-operative Pain After Laparoscopic Appendectomy for Perforated Appendicitis: A Prospective Randomized Trial

Conditions
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Perforated Appendicitis

Intervention / Treatment
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* Drug: IV tylenol
* Drug: No IV tylenol
* Drug: Ketorolac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV tylenol<br>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. | Drug: IV tylenol<br>* IV tylenol given scheduled in addition to standard PCA<br>* Other names: acetaminophen,;Drug: Ketorolac<br>* both groups receive as part of our standard postop pain protocol after all operations<br>* Other names: toradol;|
| Active Comparator: No IV tylenol<br>Same as above without IV tylenol. | Drug: No IV tylenol<br>* No additional IV Tylenol given<br>Drug: Ketorolac<br>* both groups receive as part of our standard postop pain protocol after all operations<br>* Other names: toradol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Duration of Hospital Stay | The investigators will measure postoperative time to discharge | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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appendicitis, pain, perforation