Actively Recruiting
Pre-emptive Scalp Injection of Triamcinolone Acetonide Plus Ropivacaine for Post-Craniotomy Pain in Children A Randomized Study
Led by Beijing Tiantan Hospital · Updated on 2025-01-16
128
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating postoperative pain management in children aged 2 to 12 years who undergo craniotomy surgery. This study focuses on improving pain control, which is challenging due to the difficulty of assessing pain in young children and the added complications from craniotomy such as changes in consciousness and sleepiness. The trial evaluates whether using a combination of the steroid triamcinolone acetonide and the local anesthetic ropivacaine can better relieve pain after surgery compared to ropivacaine alone. Participants are assigned to one of two groups. One group receives a mixture of 0.2% ropivacaine with triamcinolone acetonide injected under the scalp along the incision before surgery. The other group receives only ropivacaine injected in the same way. The volume of the injection is adjusted based on the length of the incision and recorded by investigators. This pre-emptive scalp infiltration aims to reduce pain by blocking inflammatory mediators around the wound. During the study, researchers will monitor pain levels using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale at 24 hours after surgery. The study includes children with good physical health status who are expected to recover fully within 2 hours after surgery. Safety and pain relief are carefully assessed to understand how well the treatments work and to monitor any side effects throughout the postoperative period.
CONDITIONS
Official Title
Pre-emptive Scalp Infiltration with Triamcinolone Acetonide Plus Ropivacaine for Post-Craniotomy Pain in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 to 12 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Expected to fully recover within 2 hours after surgery
- Informed consent provided by parent(s) or legal guardian
You will not qualify if you...
- Allergy to local anesthetics
- Age less than 2 years or greater than 12 years
- Currently taking analgesic medications
- Psychiatric disorders
- Uncontrolled epilepsy
- Chronic headache
- Infection around the surgical incision site
- Blood clotting or bleeding disorders
- Expected to remain intubated and on mechanical ventilation after surgery
- Emergency craniotomies
- Cardiac insufficiency or severe liver or kidney diseases
- Parent(s) or legal guardian unwilling to consent to participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
F
Fang Luo
Q
Qiang Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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