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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03496259
Other study ID # H-42606
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date December 1, 2021

Study information

Verified date January 2022
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Open abdominal and pelvic surgery or thoracotomy (open chest surgery) is frequently performed for tumor excision in children. Post-operative pain management regimens are often at the discretions of the attending surgeon and may include opiods, patient administered analgesia (PCA), epidural catheters, subcutaneous analgesia catheters or NSAIDS to control incisional pain. Currently, both epidural or subcutaneous analgesia catheters (On-Q pumps) are commonly used for children undergoing these operations, at the discretion of the surgeon. There are no studies comparing these regimens in children. The purpose of this study is to compare postoperative pain control of the two strategies.


Description:

The study design is a randomized, controlled trial to compare the effectiveness of on-q pump subcutaneous incisional analgesia to epidural analgesia for postoperative pain relief in children undergoing open abdominal, thoracic, or pelvic operations for oncologic purposes. The patient and treating team will be blinded to the pain control device. The primary outcome is additional narcotic usage for 3 post-operative days, and secondary outcomes are pain scores for 3 post-operative days, post-surgical day of ambulation, time to regular diet, infectious complications (UTI, wound infection or pneumonia), and hospital length of stay. Outcomes from both groups will be directly compared in order to determine whether one strategy provides more effective pain control with less complications than the other, or whether they are equivalent.


Recruitment information / eligibility

Status Terminated
Enrollment 32
Est. completion date December 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Months to 18 Years
Eligibility Inclusion Criteria: - Weight > 5kg - Age younger than 19 years of age - Planned abdominal, pelvic or thoracic operation for an oncologic indication Exclusion Criteria: - Patients deemed inappropriate for placement of epidural by anesthesiologist - Minimally invasive operation - Biopsy through limited incision - History of chronic narcotic or opioid use - History of drug abuse

Study Design


Related Conditions & MeSH terms


Intervention

Device:
On-Q pump
Type of pain control device used
Epidural catheter
Type of pain control device used

Locations

Country Name City State
United States Texas Children's Hospital Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Additional narcotic use Mg of additional narcotics used for 3 post-operative days 3 days
Secondary Pain scores Visual analog scores provided by patients every 4 hours will be collected for 3 post-operative days 3 days
Secondary Days to ambulation The first post-operative day that patients are ambulating outside the room will be noted 0-5 days
Secondary Days to initiation of regular diet The first post-operative day of initiation of a regular diet will be noted 0-5 days
Secondary Development of postoperative infection Infections (such as urinary tract infection, wound infection, or epidural site infection) will be noted 0-5 days
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