Very Low Dose Caudal Morphine for Postoperative Pain Management
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Caudal Anesthesia |
Procedure: Caudal block |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | The Use of Very Low Dose Caudal Morphine for Postoperative Pain Management in Out Patients |
- The study's primary research question, which relates to between-group differences is duration of analgesia. [ Time Frame: 1 year 5 months ] [ Designated as safety issue: Yes ]
- Between-group differences in the proportion of patients clinically significant side effects will be assessed. [ Time Frame: 1 year 5 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
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.
Other Names:
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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.
Eligibility| Ages Eligible for Study: | 1 Month to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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.
Contacts and Locations| United States, Oklahoma | |
| The University of Oklahoma Health Sciences Center Deparment of Anesthesiology | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: | Alberto J. de Armendi, MD, AM, MBA | Oklahoma University Health Sciences Center |
More Information
Publications:
| Responsible Party: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00938821 History of Changes |
| Other Study ID Numbers: | 15028 |
| Study First Received: | July 9, 2009 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Morphine Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013