protocolSection identificationModule nctId: NCT06321354, orgStudyIdInfo id: KY 2018-066-02-3, briefTitle: Pre-emptive Infiltration of the Scalp With Diprospan Plus Ropivacaine for Pain After Craniotomy in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-10-18, completionDateStruct date: 2024-11-02, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, collaborators name: Beijing Children's Hospital, descriptionModule briefSummary: 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. Researchers have clarified that the addition of diprospan to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of diprospan to local infiltration for patients receiving craniotomy.Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children., conditionsModule conditions: Pain, conditions: Postoperative Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: The diprospan plus ropivacaine group, interventions name: The ropivacaine group, outcomesModule primaryOutcomes measure: modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS), secondaryOutcomes measure: modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS), secondaryOutcomes measure: The time to the first rescue analgesic, secondaryOutcomes measure: Patient satisfactory scale (PSS), secondaryOutcomes measure: Length of stay (LOS), secondaryOutcomes measure: The occurrence of postoperative nausea and vomiting (PONV), secondaryOutcomes measure: Ramsay Sedation Scale (RSS), secondaryOutcomes measure: The occurrence of respiratory depression, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Mean arterial pressure, secondaryOutcomes measure: The total consumption of opioids during the operation, secondaryOutcomes measure: The total consumption of anaesthetic during the operation, secondaryOutcomes measure: Wound Healing Score, secondaryOutcomes measure: Incisional related adverse events, secondaryOutcomes measure: The occurrence of the Adverse events (AEs) and serious adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Beijing Children's hospital affiliated to capital medical university, status: RECRUITING, city: Beijing, state: Beijing, zip: 100045, country: China, contacts name: Ge Ming, M.D, role: CONTACT, phone: 010-59616408, email: geming88@126.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Tiantan Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100070, country: China, contacts name: Luo Fang, M.D, role: CONTACT, phone: +86 13611326978, email: 13611326978@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False