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Clinical Trials/NCT00938821
NCT00938821
Completed
Not Applicable

The Use of Very Low Dose Caudal Morphine for Postoperative Pain Management in Out Patients

University of Oklahoma1 site in 1 country33 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caudal Anesthesia
Sponsor
University of Oklahoma
Enrollment
33
Locations
1
Primary Endpoint
The study's primary research question, which relates to between-group differences is duration of analgesia.
Status
Completed
Last Updated
8 years ago

Overview

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
December 11, 2012
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 1 year 5 months

Secondary Outcomes

  • Between-group differences in the proportion of patients clinically significant side effects will be assessed.(1 year 5 months)

Study Sites (1)

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