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

Perforated Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881996
• Other study ID #: 13100328
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: August 2016

Study information

• Verified date: December 2020
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Perforated Appendicitis

Intervention

Drug:
• IV tylenol
IV tylenol given scheduled in addition to standard PCA
• No IV tylenol
No additional IV Tylenol given
• Ketorolac
both groups receive as part of our standard postop pain protocol after all operations

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	4 days
Secondary	Postoperative Duration of Hospital Stay	The investigators will measure postoperative time to discharge	1 week