Caudal Anesthesia Clinical Trial
Official title:
The Use of Very Low Dose Caudal Morphine for Postoperative Pain Management in Out Patients
Verified date | November 2017 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a chart review. The aim of this study is to investigate the effectiveness and side effects of very low dose morphine administered caudally to children that went to surgical procedures that used caudal anesthesia. The study compares caudal block with Bupivacaine (1 ml kg_1 of bupivacaine 0.25% and saline 0.02 ml kg_10) with very low dose morphine (a mix of 1 ml kg_-1 of ropivacaine 0.2% and preservative-free morphine: 10 µg kg-1).
Status | Completed |
Enrollment | 33 |
Est. completion date | December 11, 2012 |
Est. primary completion date | December 11, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 10 Years |
Eligibility |
Inclusion Criteria: - The subject did have elective Urological procedures such us circumcision, orchidopexy and inguinal hernia repair, orthopedic and general surgery procedures for which caudal block are usually administered for pain management. Exclusion Criteria: - Subjects with non elective or emergency surgery (must have the surgery no matter what). - Subjects with surgical procedures that are not planned to be conducted with the use of general anesthesia. Subjects that are not allowed to receive the anesthesia agents indicated per protocol and general anesthesia. - American Society of Anesthesiologists, Physical Status classification greater than 2 (uncontrolled systemic disease or more than one systemic disease). - Patients with a history of chronic pain conditions. - Infection around the sacral hiatus. - Coagulopathy. - Anatomic abnormalities. - Patient with mentally retardation. - Patient with history of attention deficit and/or behavioral problems. |
Country | Name | City | State |
---|---|---|---|
United States | The University of Oklahoma Health Sciences Center Deparment of Anesthesiology | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
Castillo-Zamora C, Castillo-Peralta LA, Nava-Ocampo AA. Dose minimization study of single-dose epidural morphine in patients undergoing hip surgery under regional anesthesia with bupivacaine. Paediatr Anaesth. 2005 Jan;15(1):29-36. — View Citation
Cesur M, Alici HA, Erdem AF, Yapanoglu T, Silbir F. Effects of reduction of the caudal morphine dose in paediatric circumcision on quality of postoperative analgesia and morphine-related side-effects. Anaesth Intensive Care. 2007 Oct;35(5):743-7. — View Citation
Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD003005. doi: 10.1002/14651858.CD003005.pub2. Review. — View Citation
Eschertzhuber S, Hohlrieder M, Keller C, Oswald E, Kuehbacher G, Innerhofer P. Comparison of high- and low-dose intrathecal morphine for spinal fusion in children. Br J Anaesth. 2008 Apr;100(4):538-43. doi: 10.1093/bja/aen025. Epub 2008 Feb 27. — View Citation
Hong D, Flood P, Diaz G. The side effects of morphine and hydromorphone patient-controlled analgesia. Anesth Analg. 2008 Oct;107(4):1384-9. doi: 10.1213/ane.0b013e3181823efb. — View Citation
Kawaraguchi Y, Otomo T, Ota C, Uchida N, Taniguchi A, Inoue S. A prospective, double-blind, randomized trial of caudal block using ropivacaine 0.2% with or without fentanyl 1 microg kg-1 in children. Br J Anaesth. 2006 Dec;97(6):858-61. Epub 2006 Sep 13. — View Citation
Krane EJ, Tyler DC, Jacobson LE. The dose response of caudal morphine in children. Anesthesiology. 1989 Jul;71(1):48-52. — View Citation
Mayhew J, Siddiqui S. Very low dose of caudal morphine. Paediatr Anaesth. 2005 Jul;15(7):623. — View Citation
Mayhew JF, Brodsky RC, Blakey D, Petersen W. Low-dose caudal morphine for postoperative analgesia in infants and children: a report of 500 cases. J Clin Anesth. 1995 Dec;7(8):640-2. — View Citation
Tsui BC, Berde CB. Caudal analgesia and anesthesia techniques in children. Curr Opin Anaesthesiol. 2005 Jun;18(3):283-8. — View Citation
Tyler DC, Krane EJ. Epidural opioids in children. J Pediatr Surg. 1989 May;24(5):469-73. Review. — View Citation
Voepel-Lewis T, Merkel S, Tait AR, Trzcinka A, Malviya S. The reliability and validity of the Face, Legs, Activity, Cry, Consolability observational tool as a measure of pain in children with cognitive impairment. Anesth Analg. 2002 Nov;95(5):1224-9, table of contents. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The study's primary research question, which relates to between-group differences is duration of analgesia. | 1 year 5 months | ||
Secondary | Between-group differences in the proportion of patients clinically significant side effects will be assessed. | 1 year 5 months |
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