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

Capital Medical University

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Children; Pain

Treatments: Drug: The triamcinolone acetonide plus ropivacaine group; Drug: The ropivacaine group

Study type: Interventional

Funder types: Other

Identifiers

NCT06779396

KY 2018-066-02-4

Details and patient eligibility

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

Experimental: The triamcinolone acetonide plus ropivacaine group

Experimental group

Description:

Patients in the triamcinolone acetonide plus ropivacaine group will receive a peri-incisional scalp infiltration with 0.2% ropivacaine(40mg) and 4 mg of triamcinolone acetonide and normal saline miscible liquids.

Treatment:

Drug: The triamcinolone acetonide plus ropivacaine group

Active Comparator: The ropivacaine group

Active Comparator group

Description:

Patients in the ropivacaine group will receive a peri-incisional scalp infiltration 0.2% ropivacaine(40mg)

Treatment:

Drug: The ropivacaine group