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| Sponsored by: |
Children's Mercy Hospital Kansas City |
| Information provided by: | Children's Mercy Hospital Kansas City |
| ClinicalTrials.gov Identifier: | NCT00413582 |
Purpose
The objective of this study is to scientifically evaluate two different management strategies for post-operative pain after pectus excavatum repair.
The hypothesis is that pain management without an epidural decreases hospital stay without compromising comfort.
The primary outcome variable is length of hospitalization after the intervention.
| Condition | Intervention |
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Postoperative Pain |
Drug: Epidural Analgesia Drug: Patient-Controlled IV Analgesia |
| ChemIDplus related topics: | Fentanyl Citrate Fentanyl Clonidine Midazolam Midazolam hydrochloride Midazolam maleate Hydromorphone Hydromorphone hydrochloride Clonidine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prospective Randomized Trial: Pain Management Strategy After Pectus Excavatum Repair |
| Estimated Enrollment: | 110 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | November 2009 |
| Arms | Assigned Interventions |
|
1: Active Comparator
Epidural analgesia
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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 ropivicaine 0.10% (max 10 ml), fentanyl 1 - 1.2 mcg/kg and clonidine 1.8 - 2mcg/kg. An infusion of ropivicaine 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.
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2: Experimental
IV narcotic analgesia
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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.
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This will be a single institution, prospective, randomized clinical trial involving patients who undergo the minimally invasive repair of a pectus excavatum deformity with bar placement. This is intended to be a definitive study.
Power calculations based on the known length of hospitalization listed above with α = 0.05 and power of 0.8 show the need for 55 patients in each arm. The primary end point will be reached during the hospital stay; therefore, we expect a very small amount of attrition and will intend to recruit 110. One group will undergo an attempt for epidural regional analgesia (epidural) for post-operative pain control. The other groups will receive patient controlled intravenous systemic analgesia (PCA).
Both groups will have the same management algorithm. All data will be analyzed on intention-to-treat basis.
Eligibility
| Ages Eligible for Study: | 8 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shawn D St. Peter, MD | (816)234-3575 ext 6465 | sspeter@cmh.edu |
| Contact: Susan W Sharp, PhD | (816)234-3575 ext 6670 | swsharp@cmh.edu |
| United States, Missouri | |||||
| Children's Mercy Hospital | Recruiting | ||||
| Kansas City, Missouri, United States, 64108 | |||||
| Contact: Shawn D St. Peter, MD 816-234-3575 ext 6465 sspeter@cmh.edu | |||||
| Principal Investigator: Shawn D St. Peter, MD | |||||
| Sub-Investigator: Kathy A Weesner, MD | |||||
| Sub-Investigator: Susan W Sharp, PhD | |||||
| Children's Mercy Hospital Kansas City |
| Principal Investigator: | Shawn D St. Peter, MD | Children's Mercy Hospital |
More Information
| Study ID Numbers: | 06 08 128 |
| First Received: | December 18, 2006 |
| Last Updated: | November 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00413582 |
| Health Authority: | United States: Institutional Review Board |
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