Pain relief for children after brain surgery using a local anesthetic and steroid
Official title: Pre-emptive Scalp Infiltration with Triamcinolone Acetonide Plus Ropivacaine for Post-Craniotomy Pain in Children
Run by Beijing Tiantan Hospital · NCT06779396 · Data updated 2026-11-12
This study is testing a combination of a local anesthetic and a steroid to see if it can help reduce pain after brain surgery in children aged 2 to 12 while avoiding the side effects of stronger pain medications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 10, 2025 |
| Main results expected | March 31, 2025 |
| Study ends | May 31, 2025 |
| Registry record updated | January 16, 2025 |
| Trial ID | NCT06779396 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 2 to 12 years who are undergoing elective craniotomy and are expected to recover fully within two hours postoperatively.
✕Probably not a fit
Patients who may not benefit from this study include those with allergies to local anesthetics, chronic headaches, or severe underlying health conditions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of pre-emptive scalp infiltration with triamcinolone acetonide combined with ropivacaine to manage postoperative pain in children undergoing craniotomy. The study aims to improve pain control while minimizing the side effects associated with systemic opioids. By evaluating the analgesic effects of this combination treatment, the trial seeks to enhance recovery outcomes for pediatric patients. The trial includes children aged 2 to 12 years who are expected to recover fully within two hours post-surgery.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management for children after craniotomy, leading to faster recovery and reduced reliance on opioids.
How similar studies have gone: Previous studies have shown that local anesthetics combined with steroids can enhance postoperative analgesia, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: -(1) Age 2 to 12 years. (2) American Society of Anesthesiologists (ASA) physical status I or II. (3)Participates with an anticipated fully recovery within 2 hours postoperatively. (4)Informed consent by parent(s) and/or legal guardian. Exclusion Criteria: \- (1) Allergy to local anesthetics. (2) Pediatric patients aged\>12 or \<2 years. (3) Under medication with analgesic drugs. (4) Psychiatric disorders. (5) Uncontrolled epilepsy. (6) Chronic headache. (7) Peri-incisional infection. (8) Coagulopathy or bleeding disorder. (9) Patients who are expected to remain intubated and mechanical ventilation after surgery. (10) Emergency craniotomies. (11) Patients with cardiac insufficiency or severe kidney or liver diseases. (12) Patients whose authorized surrogates are unwilling to participate in the study
Where it's running
-
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Fang Luo — Beijing Tiantan Hospital
- Study coordinator: Fang Luo
- Email: 13611326978@163.com
- Phone: +86 13611326978
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.