Caudal AnesthesiaNCT00938821
Very Low Dose Caudal Morphine for Postoperative Pain Management
An observational study of Caudal Anesthesia, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- Caudal Anesthesia
- What is being tested?
- Caudal block
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to 11 Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 10 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Anatomic abnormalities.
- Patient with mentally retardation.
- Patient with history of attention deficit and/or behavioral problems.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Oklahoma Health Sciences Center Deparment of Anesthesiology
Oklahoma City, Oklahoma, 73104
About this study
Official title: The Use of Very Low Dose Caudal Morphine for Postoperative Pain Management in Out Patients
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).
Read the 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.
- Conditions
- Caudal Anesthesia
- Being tested
- Caudal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal blockProcedure or surgery
Also called Postoperative pain, Morphine, Bupivacaine
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study's primary research question, which relates to between-group differences is duration of analgesia.
Measured: 1 year 5 months
Secondary outcomes (1)
Between-group differences in the proportion of patients clinically significant side effects will be assessed.
Measured: 1 year 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startJan 2010
- Primary completion11 Dec 2012
- Study completion11 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Caudal AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alberto J. de Armendi, MD, AM, MBA, Principal investigator, Oklahoma University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938821
- Sponsor's protocol ID
- 15028
- Status last verified
- Nov 2017
- First submitted
- 9 Jul 2009
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16534352Mayhew 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.
PubMed 8747562Krane 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.
PubMed 2751139Kawaraguchi 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.
PubMed 16973647Cyna 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.
PubMed 18843636Hong 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.
PubMed 18806056Eschertzhuber 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.
PubMed 18305080Castillo-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.
PubMed 15649160Tyler DC, Krane EJ. Epidural opioids in children. J Pediatr Surg. 1989 May;24(5):469-73. doi: 10.1016/s0022-3468(89)80404-x.
PubMed 2567780Cesur 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.
PubMed 17933162Mayhew 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.
PubMed 15960653Voepel-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.
PubMed 12401598
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Very Low Dose Caudal Morphine for Postoperative Pain Management in Out Patients
- ClinicalTrials.gov ID
- NCT00938821
- Acronym / sponsor ID
- 15028
- Conditions
- Caudal Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- 11 Dec 2012 (actual)
- Study completion
- 11 Dec 2012 (actual)
- First posted
- 14 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caudal Block | – | Procedure: Caudal blockReview of charts of patients that received very low dose morphine administered caudally (M) and plain caudal block with Ropivacaine or Marcaine (B). |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caudal blockAlso: Postoperative pain, Morphine, BupivacaineChart 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. | Procedure or surgery | Caudal Block |
Primary outcome
The study's primary research question, which relates to between-group differences is duration of analgesia.
Time frame: 1 year 5 months
1 secondary outcome
Between-group differences in the proportion of patients clinically significant side effects will be assessed.
Time frame: 1 year 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Background: PubMed 16534352Tsui 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.
- Background: PubMed 8747562Mayhew 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.
- Background: PubMed 2751139Krane 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.
- Background: PubMed 16973647Kawaraguchi 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.
- Background: PubMed 18843636Cyna 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.
- Background: PubMed 18806056Hong 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.
- Background: PubMed 18305080Eschertzhuber 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.
- Background: PubMed 15649160Castillo-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.
- Background: PubMed 2567780Tyler DC, Krane EJ. Epidural opioids in children. J Pediatr Surg. 1989 May;24(5):469-73. doi: 10.1016/s0022-3468(89)80404-x.
- Background: PubMed 17933162Cesur 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.
- Background: PubMed 15960653Mayhew 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.
- Background: PubMed 12401598Voepel-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto J. de Armendi, MD, AM, MBA principal investigator
Oklahoma University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caudal Anesthesia, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The study's primary research question, which relates to between-group differences is duration of analgesia. (time frame: 1 year 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00938821, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.