NCT02881996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

January 12, 2021

Completed
Last Updated

January 12, 2021

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

January 18, 2016

Results QC Date

August 28, 2020

Last Update Submit

December 18, 2020

Conditions

Perforated Appendicitis

Keywords

appendicitispainperforation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Postoperative Duration of Hospital Stay

    1 week

Study Arms (2)

IV tylenol

EXPERIMENTAL

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 tylenolDrug: Ketorolac

No IV tylenol

ACTIVE COMPARATOR

Same as above without IV tylenol.

Drug: No IV tylenolDrug: Ketorolac

Interventions

IV tylenolDRUG

IV tylenol given scheduled in addition to standard PCA

Also known as: acetaminophen,
IV tylenol
No IV tylenolDRUG

No additional IV Tylenol given

No IV tylenol
KetorolacDRUG

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

Also known as: toradol
IV tylenolNo IV tylenol

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All patients ages 2-17 years old undergoing laparoscopic appendectomy at CMH found to have perforated appendicitis.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

AppendicitisPain

Interventions

AcetaminophenKetorolacKetorolac Tromethamine

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Shawn St. Peter
Organization
Children's Mercy Hospital
sspeter@cmh.edu
816-234-3000

Study Officials

  • Shawn D St. Peter, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

August 29, 2016

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

January 12, 2021

Results First Posted

January 12, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)