Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05444036
Status:
COMPLETED
Last Update Posted:
2022-09-10
First Post:
2022-06-21
Brief Title:
Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline
Sponsor:
Egymedicalpedia
Organization:
Egymedicalpedia
Study Overview
Official Title:
Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline in Pediatric Surgical Procedures Below the Umbilicus
Status:
COMPLETED
Status Verified Date:
2022-06
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:
Because pain is difficult to measure in children post-operative pain is frequently undertreated in this age range Pain treatment is required in children due to the high emotional component of pain Pain is a multidimensional subjective perceptual event having a variety of qualities such as intensity quality time course and effects that are perceived differently by each person Because the operational definition of pain necessitates self-report pain experienced by children and babies is frequently overlooked if not ignored
When general anesthesia is paired with regional procedures children of all ages are exposed to less intravenous and inhalational anesthetics and analgesics leaving them nearly free of nausea vomiting itching or unneeded drowsiness Being completely awake and able to drink soon after surgery as well as having no issues breathing even after lengthy surgery are significant benefits that children and parents value
When general anesthesia is paired with regional procedures children of all ages are exposed to less intravenous and inhalational anesthetics and analgesics leaving them nearly free of nausea vomiting itching or unneeded drowsiness Being completely awake and able to drink soon after surgery as well as having no issues breathing even after lengthy surgery are significant benefits that children and parents value
Detailed Description:
Caudal block provides the potential benefit of extending the length and effectiveness of the block by combining additional medications with the local anaesthetic agent Morphine clonidine ketamine and midazolam were among the drugs used
Although peripheral nerve blocks and caudal anesthesia are relatively safe extreme attention is required to minimize adverse consequences Pediatric anesthesiologists must have adequate training to ensure patient safety A well-trained pediatric anesthesiologist will try to avoid unsafe regional anesthetic application methods and will always be prepared to manage dangerous side effects overdoses intravenous administration induced seizures tip displacement of epidural catheters or centrally located abscesses
Ketamine is a non-competitive N-methyl D-aspartate NMDA receptor antagonist that is thought to prevent or reverse central sensitization and as a result lessen postoperative pain It also has a peripheral analgesic effect
Ketamine infiltration has been demonstrated to provide pain alleviation in children having adenotonsillectomy for up to 24 hours following surgery with no adverse effects
Although peripheral nerve blocks and caudal anesthesia are relatively safe extreme attention is required to minimize adverse consequences Pediatric anesthesiologists must have adequate training to ensure patient safety A well-trained pediatric anesthesiologist will try to avoid unsafe regional anesthetic application methods and will always be prepared to manage dangerous side effects overdoses intravenous administration induced seizures tip displacement of epidural catheters or centrally located abscesses
Ketamine is a non-competitive N-methyl D-aspartate NMDA receptor antagonist that is thought to prevent or reverse central sensitization and as a result lessen postoperative pain It also has a peripheral analgesic effect
Ketamine infiltration has been demonstrated to provide pain alleviation in children having adenotonsillectomy for up to 24 hours following surgery with no adverse effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None