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

Children's Mercy Hospital Kansas City

Status

Completed

Conditions

Perforated Appendicitis

Treatments

Drug: No IV tylenol

Drug: Ketorolac

Drug: IV tylenol

Study type

Interventional

Funder types

Other

Identifiers

NCT02881996

13100328

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

2 to 17 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

IV tylenol

Experimental group

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.

Treatment:

Drug: IV tylenol

Drug: Ketorolac

No IV tylenol

Active Comparator group

Description:

Same as above without IV tylenol.

Treatment:

Drug: Ketorolac

Drug: No IV tylenol