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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
Type of pain control device used
Type of pain control device used
Texas Children's Hospital
Houston, Texas, United States
Additional narcotic use
Mg of additional narcotics used for 3 post-operative days
Time frame: 3 days
Pain scores
Visual analog scores provided by patients every 4 hours will be collected for 3 post-operative days
Time frame: 3 days
Days to ambulation
The first post-operative day that patients are ambulating outside the room will be noted
Time frame: 0-5 days
Days to initiation of regular diet
The first post-operative day of initiation of a regular diet will be noted
Time frame: 0-5 days
Development of postoperative infection
Infections (such as urinary tract infection, wound infection, or epidural site infection) will be noted
Time frame: 0-5 days
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