CI

At a glance

ClinicalIndex Comparison Record
Phase 4Unknown· 90 target
Drug / intervention
Methylprednisolone +1 moredrug
Likely dose
Methylprednisolone 1.25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03636165
NCT03636165Phase 4Unknown

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

Beijing Tiantan Hospital·interventional·Posted Aug 17, 2018·Updated Oct 27, 2021

In Brief

A Phase 4 clinical trial evaluating Methylprednisolone and Ropivacaine for Pain, Postoperative and Post-Craniotomy Headache. Targeting 90 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4UnknownOverdue
20192020202120222023202420252026
First PostedAug 17, 2018
Enrollment StartSep 1, 2022
Primary CompletionDec 1, 2023
TodayJul 1, 2026
Enrollment to primary: 1.3 yearsPosted 7.9 years ago

Interventions

Methylprednisolonedrug

The local infiltration solution containing 1.25mg Methylprednisolone per milliliter.

Ropivacainedrug

The local infiltration solution containing 2mg Ropivacaine per milliliter.