Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070, China
Location status: Recruiting
NCT Number: NCT06779396
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.
Interested in participating?
Request Info2 year–12 year
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100070, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
(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
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.
Time frame: At 24 hours after the operation
Postoperative pain will be estimated by usingthe Faces, Legs, Activity, Cry, Consolability (FLACC) scale score at 24 hours postoperatively.
Time frame: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery
Postoperative pain will be estimated by using the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
Time frame: Within 48 hours after the operation
the time to the first postoperative analgesic request
Time frame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery
PONV will be rated by participants as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.
Time frame: Approximately 1 weeks after the operation
Incisional related adverse events Including delayed incisional healing, incisional infection, intracranial infection, scar healing.
Time frame: Within 1 weeks after the operation
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: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery
0 for unsatisfactory, and 10 for very satisfied
Time frame: During procedure
Contact information is provided by the study sponsor or research team.
Fang Luo
CONTACT
Qiang Liu
CONTACT
Beijing Tiantan Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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