Pre-emptive Infiltration of the Scalp with Diprospan Plus Ropivacaine for Pain After Craniotomy in Children

• The diprospan plus ropivacaine group (Drug): The local infiltration solution containing 0.5ml diprospan and 15mg of 1% ropivacaine. The total volume is 30 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 ropivacaine group (Drug): The local infiltration solution containing 15mg of 1% ropivacaine. The total volume is 30 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.

Primary outcomes

• modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) [At 24 hours after the operation]: Postoperative pain will be estimated by using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS). 0 indicates no pain, 10 indicates the most severe pain imaginable.

Secondary outcomes

• modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) [At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery]: Postoperative pain will be estimated by using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS). 0 indicates no pain, 10 indicates the most severe pain imaginable.
• The time to the first rescue analgesic [Within 48 hours after the operation]: Rescue analgesics will be administered if the patient exhibits signs of sympathetic stimulation in the form of undue tachycardia, a rise in mean arterial pressure (rise of >20% from the baseline), and mCHEOPS score above 5 (range 1 to 10) or if the children are in obvious pain and distress at any time point during a subjective assessment by the intensivist or parents.
• 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
• Length of stay (LOS) [Approximately 1 weeks after the operation]: LOS will be recorded as the number of nights spent in hospital after surgery.
• 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.
• Ramsay Sedation Scale (RSS) [At 2 hours, 4 hours, 8 hours, 24 hours after surgery]: 1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.
• The occurrence of respiratory depression [Within 48 hours after the operation]: Respiratory depression is defined as persistent (more than 1 minutes) oxygen desaturation 90 percent or respiratory rate less than 8 breaths per minute, or oxygen desaturation less than 94 percent along with respiratory rate less than 10 breaths per minute requiring supplemental oxygen to maintain oxygen saturation more than 94 percent in the absence of clinically obvious upper airway obstruction.
• Heart rate [During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery]
• Mean arterial pressure [During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery]
• The total consumption of opioids during the operation [During procedure]
• The total consumption of anaesthetic during the operation [During procedure]
• Wound Healing Score [At 1 month after surgery]: Skin Healing 1: fully healed; 2: ≤3 cm in total not healed; 3: >3 cm not healed; 4: areas of necrosis ≤3 cm; 5: areas of necrosis >3 cm Infection 1: none; 2: ≤0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth 1: even regrowth along wound; 2: ≤3 cm not regrowing; 3: >3-6 cm not regrowing; 4: >6 cm not regrowing; not applicable
• 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 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.

Sex: All, ages: 2 Years to 12 Years

Inclusion Criteria:

* An elective craniotomy under general anesthesia; American Society of Anesthesiologists (ASA) physical status of I or II; Participates with an anticipated fully recovery within 2 hours postoperatively; Informed consent by parent(s) and/or legal guardian.

Exclusion Criteria:

* History of allergies to any of the study drugs; Drugs with confirmed or suspected sedative or analgesic effects; receiving any painkiller within 24 h before surgery; children who received steroids; Psychiatric disorders; Uncontrolled epilepsy; Chronic headache; Peri-incisional infection; Body mass index exceeded the 99th percentile for age; Children who must use a patient-controlled analgesia (PCA) device; Children who cannot understand an instruction of pain scales before surgery

• Luo Fang, M.D, Principal investigator, Beijing Tiantan Hospital
• Ge Ming, M.D, Principal investigator, Beijing Children's hospital affiliated to capital medical university