Actively Recruiting

Phase 4
Age: 2Years - 12Years
All Genders
ID06779396

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

Age: 2Years - 12Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

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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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Pre-emptive Scalp Injection of Triamcinolone Acetonide Plus Ropivacaine for Post-Craniotomy Pain in Children A Randomized Study | DecenTrialz