Pain, Postoperative Children
Conditions
Keywords
Postoperative Pain, Pre-emptive Scalp Infiltration, Triamcinolone Acetonide
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.
Interventions
DRUGThe triamcinolone acetonide plus 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.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Faces, Legs, Activity, Cry, Consolability (FLACC) scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of analgesia | Within 48 hours after the operation | the time to the first postoperative analgesic request |
| The occurrence of postoperative nausea and vomiting (PONV) | 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. |
| Incisional related adverse events | Approximately 1 weeks after the operation | Incisional related adverse events Including delayed incisional healing, incisional infection, intracranial infection, scar healing. |
| the Faces, Legs, Activity, Cry, Consolability (FLACC) scale | 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 |
| Patient satisfactory scale (PSS) | At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery | 0 for unsatisfactory, and 10 for very satisfied |
| The total consumption of opioids during the operation | During procedure | — |
| The occurrence of the Adverse events (AEs) and serious adverse events (SAEs) | 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. |
Countries
China
Contacts
Primary ContactFang Luo
Backup ContactQiang Liu
Outcome results
None listed