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

NCT ID: NCT02881996

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-08-31

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.

Conditions

Perforated Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

IV tylenol

Intervention Type: DRUG

IV tylenol given scheduled in addition to standard PCA

Ketorolac

Intervention Type: DRUG

both groups receive as part of our standard postop pain protocol after all operations

No IV tylenol

Same as above without IV tylenol.

Group Type: ACTIVE_COMPARATOR

No IV tylenol

Intervention Type: DRUG

No additional IV Tylenol given

Ketorolac

Intervention Type: DRUG

both groups receive as part of our standard postop pain protocol after all operations

Interventions

IV tylenol

IV tylenol given scheduled in addition to standard PCA

Intervention Type: DRUG

No IV tylenol

No additional IV Tylenol given

Intervention Type: DRUG

Ketorolac

both groups receive as part of our standard postop pain protocol after all operations

Intervention Type: DRUG

Other Intervention Names

acetaminophen,; toradol

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shawn D St. Peter, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

Children's Mercy Hospital

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

13100328

Identifier Type: -

Identifier Source: org_study_id