Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321354
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-14
Brief Title:
Pre-emptive Infiltration of the Scalp With Diprospan Plus Ropivacaine for Pain After Craniotomy in Children
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Pre-emptive Infiltration of the Scalp With Diprospan Plus Ropivacaine for Pain After Craniotomy in Children
Status:
RECRUITING
Status Verified Date:
2024-04
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:
At present pediatric postoperative analgesia has not been fully understood and controlled particularly craniotomy surgery On the one hand professional evaluation of postoperative pain for young children is difficult on the other hand the particularity of craniotomy adds such as consciousness obstacle sleepiness et al disturbance to the pain assessment in children Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management it may be associated with delayed awakening respiratory depression hypercarbia and it may interfere with the neurologic examination For the avoidance of side-effects of systemic opioids local anesthetics administered around the incision have been performed clinically However some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction Researchers have clarified that the addition of diprospan to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries To date no studies have evaluated the addition of diprospan to local infiltration for patients receiving craniotomy
Thus investigators suppose that pre-emptive scalp infiltration with steroid Diprospan plus local anesthetic ropivacaine could relieve postoperative pain after craniotomy in children
Thus investigators suppose that pre-emptive scalp infiltration with steroid Diprospan plus local anesthetic ropivacaine could relieve postoperative pain after craniotomy in children
Detailed Description:
None
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