Actively Recruiting

Phase 4
Age: 2Years - 12Years
All Genders
NCT06779396

Pre-emptive Scalp Infiltration with Triamcinolone Acetonide Plus Ropivacaine for Post-Craniotomy Pain in Children

Led by Beijing Tiantan Hospital · Updated on 2025-01-16

128

Participants Needed

1

Research Sites

20 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.However, there has not been reported about local application of triamcinolone acetonide on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (triamcinolone acetonide) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.

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

CONTACT

Q

Qiang Liu

CONTACT

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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