NCT03636165

Scalp Infiltration With Methylprednisolone Plus Ropivacaine for Post-Craniotomy Pain in Children

Pre-emptive Scalp Infiltration With Ropivacaine Plus Methylprednisolone vs Ropivacaine Alone for Relief of Postoperative Pain After Craniotomy in Children (RP/MP vs RP)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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. Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Methylprednisolone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.

Conditions

• Pain, Postoperative
• Post-Craniotomy Headache

Interventions

Type	Name	Description
DRUG	Methylprednisolone	The local infiltration solution containing 1.25mg Methylprednisolone per milliliter.
DRUG	Ropivacaine	The local infiltration solution containing 2mg Ropivacaine per milliliter.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2018-08-17
• Last updated: 2021-10-27