Scalp Infiltration With Methylprednisolone Plus Ropivacaine for Post-Craniotomy Pain in Children (NCT03636165) | Clinical Trial Compass
UnknownPhase 4
Scalp Infiltration With Methylprednisolone Plus Ropivacaine for Post-Craniotomy Pain in Children
90 participantsStarted 2022-09-01
Plain-language 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.
Who can participate
Age range
8 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. An elective craniotomy under general anesthesia;
. American Society of Anesthesiologists (ASA) physical status of I or II;
. Participates with an anticipated fully recovery within 2 hours postoperatively；
. Informed consent by parent(s) and/or legal guardian.
Exclusion criteria
. History of allergies to any of the study drugs;
. Excessive alcohol or drug abuse, chronic opioids use (more than 2 weeks or 3 days per week for more than 1 month), or drugs with confirmed or suspected sedative or analgesic effects; receiving any painkiller within 24 h before surgery; children who received steroids；
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a scalp nerve block with methylprednisolone and ropivacaine before closing the incision — is my child a candidate for that kind of regional pain technique during their craniotomy, and what does my child's surgical team's experience with it look like?
2The trial measures how much fentanyl children need in the first 24 hours after surgery — if my child ends up needing less opioid pain medication, what does that actually mean for their recovery in practical terms, like alertness and time in the ICU?
3Since this study is Phase 4, the drugs used are already approved individually, but what is still not fully known about combining methylprednisolone and ropivacaine specifically as a scalp infiltration in children after brain surgery?
4The recruitment status for this trial is listed as unknown — is this study still actively enrolling, and if not, is there another similar pain management protocol available at this hospital that we could discuss?
5Are there any children for whom this type of scalp infiltration would NOT be recommended — for example, based on tumor location, age, or the specific type of craniotomy planned for my child?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative fentanyl consumption within 24 hours postoperatively