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

Primary Purpose

Perforated Appendicitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IV tylenol
No IV tylenol
Ketorolac
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Perforated Appendicitis focused on measuring appendicitis, pain, perforation

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IV tylenol

No IV tylenol

Arm Description

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.

Same as above without IV tylenol.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postoperative Duration of Hospital Stay
The investigators will measure postoperative time to discharge

Full Information

First Posted
January 18, 2016
Last Updated
December 18, 2020
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT02881996
Brief Title
The Impact of IV Acetaminophen on Pain After Appendectomy for Perforated Appendicitis
Official Title
Impact of IV Acetaminophen on Post-operative Pain After Laparoscopic Appendectomy for Perforated Appendicitis: A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perforated Appendicitis
Keywords
appendicitis, pain, perforation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV tylenol
Arm Type
Experimental
Arm Description
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.
Arm Title
No IV tylenol
Arm Type
Active Comparator
Arm Description
Same as above without IV tylenol.
Intervention Type
Drug
Intervention Name(s)
IV tylenol
Other Intervention Name(s)
acetaminophen,
Intervention Description
IV tylenol given scheduled in addition to standard PCA
Intervention Type
Drug
Intervention Name(s)
No IV tylenol
Intervention Description
No additional IV Tylenol given
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
toradol
Intervention Description
both groups receive as part of our standard postop pain protocol after all operations
Primary Outcome Measure Information:
Title
Time Until PCA Discontinued After the Operation
Description
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
Secondary Outcome Measure Information:
Title
Postoperative Duration of Hospital Stay
Description
The investigators will measure postoperative time to discharge
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn D St. Peter, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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