Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130091
Status:
COMPLETED
Last Update Posted:
2015-02-20
First Post:
2005-08-11
Brief Title:
The Addition of Clonidine to 02 Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children
Sponsor:
Childrens Hospital of Eastern Ontario
Organization:
Childrens Hospital of Eastern Ontario
Study Overview
Official Title:
The Addition of Clonidine to 02 Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current study will compare the effects on postoperative pain relief of freezing ropivacaine 02 alone and in combination with clonidine for a nerve block in children undergoing hernia repair The researchers anticipate that the addition of clonidine to freezing will result in prolongation of postoperative pain relief in children undergoing hernia repair compared to freezing used alone
Detailed Description:
The optimal method of controlling postoperative pain in children undergoing hernia repair would effectively relieve pain for extended periods of time and have no adverse effects Unfortunately such an ideal technique does not exist
The control of postoperative pediatric pain after hernia repair is achieved with a combination of oral and intravenous pain medications and nerve blocks Nerve blocks are achieved by injecting local anesthetics or what is commonly referred to as freezing next to the nerve supply of the wound Freezing the major nerves supplying sensation at the site of hernia repair in children while they are asleep is effective At CHEO this technique in addition to administering ketorolac a liquid intravenous form of an anti-inflammatory agent similar to Advil is the current technique of choice for postoperative pain control after inguinal hernia
It is not unusual for these patients to require extra pain medications postoperatively Available means of pain control in addition to those mentioned above include codeine-like medications Tylenol Advil-like medications and opioids administered intravenously The addition of these medications increases the risk of suffering from side effects including respiratory depression nausea and vomiting and itching
Ideally the prolongation of postoperative pain relief by the addition of a second medication to the freezing during the nerve block would limit the need for additional pain medication and hence decrease their associated side effects Clonidine has the potential to be such a medication It has been shown to provide pain relief by affecting several areas of the nervous system including the brain the spinal cord and nerves Clonidine prolongs pain relief of certain local anesthetics when used in nerve blocks for adults Unfortunately there are no studies that have examined the combination of clonidine and the local anesthetic ropivacaine for nerve blocks in children Presently the injectable form of clonidine is not marketed and is considered investigational in Canada
The current study will be a prospective double -blind randomized controlled trial It will compare the effects on postoperative pain relief of freezing ropivacaine 02 alone and in combination with clonidine for a nerve block in children undergoing hernia repair In addition it will measure changes in the childs level of sedation breathing heart rate blood pressure and any complications Finally it will assess how satisfied the parents are with this technique
The researchers anticipate that the addition of clonidine to freezing will result in prolongation of postoperative pain relief in children undergoing hernia repair compared to freezing used alone
The control of postoperative pediatric pain after hernia repair is achieved with a combination of oral and intravenous pain medications and nerve blocks Nerve blocks are achieved by injecting local anesthetics or what is commonly referred to as freezing next to the nerve supply of the wound Freezing the major nerves supplying sensation at the site of hernia repair in children while they are asleep is effective At CHEO this technique in addition to administering ketorolac a liquid intravenous form of an anti-inflammatory agent similar to Advil is the current technique of choice for postoperative pain control after inguinal hernia
It is not unusual for these patients to require extra pain medications postoperatively Available means of pain control in addition to those mentioned above include codeine-like medications Tylenol Advil-like medications and opioids administered intravenously The addition of these medications increases the risk of suffering from side effects including respiratory depression nausea and vomiting and itching
Ideally the prolongation of postoperative pain relief by the addition of a second medication to the freezing during the nerve block would limit the need for additional pain medication and hence decrease their associated side effects Clonidine has the potential to be such a medication It has been shown to provide pain relief by affecting several areas of the nervous system including the brain the spinal cord and nerves Clonidine prolongs pain relief of certain local anesthetics when used in nerve blocks for adults Unfortunately there are no studies that have examined the combination of clonidine and the local anesthetic ropivacaine for nerve blocks in children Presently the injectable form of clonidine is not marketed and is considered investigational in Canada
The current study will be a prospective double -blind randomized controlled trial It will compare the effects on postoperative pain relief of freezing ropivacaine 02 alone and in combination with clonidine for a nerve block in children undergoing hernia repair In addition it will measure changes in the childs level of sedation breathing heart rate blood pressure and any complications Finally it will assess how satisfied the parents are with this technique
The researchers anticipate that the addition of clonidine to freezing will result in prolongation of postoperative pain relief in children undergoing hernia repair compared to freezing used alone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None