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Very Low Dose Caudal Morphine for Postoperative Pain Management

NCT ID: NCT00938821

Last Updated: 2017-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-11

Brief Summary

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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).

Detailed Description

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Caudal anesthesia is the most common technique of epidural anesthesia in children. Caudal anesthesia is recommended for most surgical procedures of the lower part of the body, including herniorrhaphies; operations on the urinary tract, anus, and rectum; and orthopedic procedures on the pelvic girdle and lower extremities. Many anesthetic agents have been used for caudal anesthesia in pediatric patients, with lidocaine and Bupivacaine being most common. The major problems associated with this technique are the limited duration of analgesia and unwanted motor blockade.

Addition of medications that prolong analgesia after a single shot caudal block has been investigated. Several authors have mentioned a special interest in using an opioid like morphine in caudal block for postoperative analgesia. When low dose morphine is used, the side effects are lower than when higher dose of morphine are used. A larger and definitive study is needed to compare very low dose morphine via caudal administration and caudal block without Opioid with regard to duration of analgesia and frequency of side effects. We plan to conduct a chart review in our center on pediatric patients that went to urological, orthopedic, and general surgery procedures for which caudal block were given and compare the effectiveness and side effects of very low dose morphine and caudal block without Opioid.

Conditions

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Caudal Anesthesia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

Caudal block

Intervention Type 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.

Interventions

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Caudal block

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.

Intervention Type PROCEDURE

Other Intervention Names

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Postoperative pain Morphine Bupivacaine

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alberto J. de Armendi, MD, AM, MBA

Role: PRINCIPAL_INVESTIGATOR

Oklahoma University Health Sciences Center

Locations

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The University of Oklahoma Health Sciences Center Deparment of Anesthesiology

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16534352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8747562 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2751139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16973647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18843636 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18806056 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18305080 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15649160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2567780 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17933162 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15960653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12401598 (View on PubMed)

Other Identifiers

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15028

Identifier Type: -

Identifier Source: org_study_id