Very Low Dose Caudal Morphine for Postoperative Pain Management

NCT00938821 | Completed DMC

• 1 other identifier: 15028
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Caudal Anesthesia

Outcome Measures

Primary Outcomes (1)

• The study's primary research question, which relates to between-group differences is duration of analgesia.

  1 year 5 months

Secondary Outcomes (1)

• Between-group differences in the proportion of patients clinically significant side effects will be assessed.

  1 year 5 months

Study Arms (1)

Caudal Block

Review of charts of patients that received very low dose morphine administered caudally (M) and plain caudal block with Ropivacaine or Marcaine (B).

Procedure: Caudal block

Interventions

Caudal block PROCEDURE

Chart review of patients that received very low dose morphine administered caudally (M) and plain caudal block with Ropivacaine or Marcaine (B)from October 2008 to October 2009.

Also known as: Postoperative pain, Morphine, Bupivacaine

Caudal Block

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This is a chart review from October 2008 to October 2009 of children from 1 month of age to 10 years old that went to 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

The University of Oklahoma Health Sciences Center Deparment of Anesthesiology

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (12)

• Tsui BC, Berde CB. Caudal analgesia and anesthesia techniques in children. Curr Opin Anaesthesiol. 2005 Jun;18(3):283-8. doi: 10.1097/01.aco.0000169236.91185.5b.

  PMID: 16534352 BACKGROUND

• 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. doi: 10.1016/0952-8180(95)00089-5.

  PMID: 8747562 BACKGROUND

• Krane EJ, Tyler DC, Jacobson LE. The dose response of caudal morphine in children. Anesthesiology. 1989 Jul;71(1):48-52. doi: 10.1097/00000542-198907000-00009.

  PMID: 2751139 BACKGROUND

• 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. doi: 10.1093/bja/ael249. Epub 2006 Sep 13.

  PMID: 16973647 BACKGROUND

• 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;2008(4):CD003005. doi: 10.1002/14651858.CD003005.pub2.

  PMID: 18843636 BACKGROUND

• 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.

  PMID: 18806056 BACKGROUND

• 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.

  PMID: 18305080 BACKGROUND

• 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. doi: 10.1111/j.1460-9592.2004.01391.x.

  PMID: 15649160 BACKGROUND

• Tyler DC, Krane EJ. Epidural opioids in children. J Pediatr Surg. 1989 May;24(5):469-73. doi: 10.1016/s0022-3468(89)80404-x.

  PMID: 2567780 BACKGROUND

• 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. doi: 10.1177/0310057X0703500514.

  PMID: 17933162 BACKGROUND

• Mayhew J, Siddiqui S. Very low dose of caudal morphine. Paediatr Anaesth. 2005 Jul;15(7):623. doi: 10.1111/j.1460-9592.2005.01662.x. No abstract available.

  PMID: 15960653 BACKGROUND

• 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. doi: 10.1097/00000539-200211000-00020.

  PMID: 12401598 BACKGROUND

MeSH Terms

Interventions

Morphine; Bupivacaine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Alberto J. de Armendi, MD, AM, MBA

  Oklahoma University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 14, 2009
• Study Start: January 1, 2010
• Primary Completion: December 11, 2012
• Study Completion: December 11, 2012
• Last Updated: November 21, 2017

Record last verified: 2017-11

Locations

US (1)