Pain Management for Pectus Excavatum Repair

NACompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

May 31, 2010

Study Completion Date

October 31, 2010

Conditions
Postoperative Pain
Interventions
DRUG

Epidural Analgesia

Upon arrival to the operating room, patients will have a thoracic epidural (T 6-9) placed while in the sitting position. All epidural catheters will be inserted 3-5 cm within the epidural space and will be placed by attending anesthesiologists. Patients will receive midazolam 0.025 - 0.05 mg/kg IV (max 5mg) and/or fentanyl 0.5 - 2 mcg/kg IV for comfort during the procedure. Once the epidural is placed, the patient will be positioned for surgery. The epidural catheter will be initially bolused with 0.3ml/kg of ropivacaine 0.10% (max 10 ml), fentanyl 1 - 1.2 mcg/kg and clonidine 1.8 - 2mcg/kg. An infusion of ropivacaine 0.10%, fentanyl 2mcg/ml and clonidine 1.5mcg/ml will be initiated immediately at the rate of 0.3ml/kg/hr (max 10ml/hr). Intraoperatively, patients will receive intravenous fentanyl if indicated.

DRUG

Patient-Controlled IV Analgesia

In the PCA arm, patients will receive fentanyl (3-6 mcg/kg) at anesthesia induction. Additional fentanyl may be administered intraoperatively as indicated. Patients who are \> 35 Kg. (in keeping with current FDA approved labeling) will receive a clonidine 0.1 mg/day transdermal patch to the deltoid immediately after induction of anesthesia. Subjects in the epidural arm also receive clonidine. Upon arrival to the post anesthesia care unit, patients will be placed on a patient controlled analgesic (PCA) pump (hydromorphone: loading dose if needed; 5-6 mcg/kg continuous infusion; 5-6 mcg/kg six minute demand dose). An additional hydromorphone dose (8mcg/kg) will be available every 2 hours for pain scores of \> 4/10 throughout the duration of PCA use.

Trial Locations (1)

64108

Children's Mercy Hospital, Kansas City

All Listed Sponsors
lead

Children's Mercy Hospital Kansas City

OTHER

NCT00413582 - Pain Management for Pectus Excavatum Repair | Biotech Hunter | Biotech Hunter