A Phase 4 interventional study of The triamcinolone acetonide plus ropivacaine group and The ropivacaine group in Pain and Postoperative Children, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by Beijing Tiantan Hospital · Phase 4, Interventional, and Prevention
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.
Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
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-(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:
(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
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.
Drug: The triamcinolone acetonide plus ropivacaine group
Patients in the ropivacaine group will receive a peri-incisional scalp infiltration 0.2% ropivacaine(40mg)
Drug: The ropivacaine group
The solution prepared comprised a mixture of 20mL of 0.2% ropivacaine(40mg) with 4 mg of triamcinolone acetonide. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.
The local infiltration solution containing 20mg of 1% ropivacaine. The total volume is 20 ml. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.
the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
Postoperative pain will be estimated by usingthe Faces, Legs, Activity, Cry, Consolability (FLACC) scale score at 24 hours postoperatively.
Time frame: At 24 hours after the operation
the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
Postoperative pain will be estimated by using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
Time frame: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery
Duration of analgesia
the time to the first postoperative analgesic request
Time frame: Within 48 hours after the operation
The occurrence of postoperative nausea and vomiting (PONV)
PONV will be rated by participants as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery
Incisional related adverse events
Incisional related adverse events Including delayed incisional healing, incisional infection, intracranial infection, scar healing.
Time frame: Approximately 1 weeks after the operation
The occurrence of the Adverse events (AEs) and serious adverse events (SAEs)
An AE was defined as any untoward medical occurrence. An SAE included death, immediately life-threatening conditions, coma, in-patient hospitalisation or prolongation of existing hospitalisation.
Time frame: Within 1 weeks after the operation
Patient satisfactory scale (PSS)
0 for unsatisfactory, and 10 for very satisfied
Time frame: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery
The total consumption of opioids during the operation
Time frame: During procedure
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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