Clinical trial NCT06779396: Pre-emptive Scalp Infiltration with Triamcinolone Acetonide Plus Ropivacaine for Post-Craniotomy Pain in Children
Official title: Pre-emptive Scalp Infiltration with Triamcinolone Acetonide Plus Ropivacaine for Post-Craniotomy Pain in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain
Postoperative Children
Keywords: Postoperative Pain
Pre-emptive Scalp Infiltration
Triamcinolone Acetonide
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 128
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.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.


Eligibility 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

Primary outcomes:
measure: the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
timeFrame: At 24 hours after the operation
Secondary outcomes:
measure: the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
timeFrame: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery
measure: Duration of analgesia
timeFrame: Within 48 hours after the operation
measure: The occurrence of postoperative nausea and vomiting (PONV)
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery
measure: Incisional related adverse events
timeFrame: Approximately 1 weeks after the operation
measure: The occurrence of the Adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Within 1 weeks after the operation
measure: Patient satisfactory scale (PSS)
timeFrame: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery
measure: The total consumption of opioids during the operation
timeFrame: During procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo
role: PRINCIPAL_INVESTIGATOR
References: