Clinical trial NCT04051723: Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children
Official title: Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Children
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Children's Hospital
First posted: 2019-08-09
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. Researchers have clarified that the addition of dexamethasone 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 dexamethasone to local infiltration for patients receiving craniotomy. Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.


Eligibility criteria: 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.

Primary outcomes:
measure: modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS)
timeFrame: At 24 hours after the operation
Secondary outcomes:
measure: modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS)
timeFrame: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week, 2 weeks after surgery
measure: The time to the first rescue analgesic
timeFrame: Within 48 hours after the operation
measure: Patient satisfactory scale (PSS)
timeFrame: At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week, 2 weeks after surgery
measure: length of stay (LOS)
timeFrame: Approximately 2 weeks after the operation
measure: The occurrence of postoperative nausea and vomiting (PONV)
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery
measure: Ramsay Sedation Scale (RSS)
timeFrame: At 2 hours, 4 hours, 8 hours, 24 hours after surgery
measure: The occurrence of respiratory depression
timeFrame: Within 48 hours after the operation
measure: Heart rate
timeFrame: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
measure: Mean arterial pressure
timeFrame: During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery
measure: The total consumption of opioids during the operation
timeFrame: During procedure
measure: The total consumption of anaesthetic during the operation
timeFrame: During procedure
measure: Wound Healing Score
timeFrame: At 1 month after surgery
measure: Incisional related adverse events
timeFrame: Approximately 2 weeks after the operation
measure: The occurrence of the Adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Within 2 weeks after the operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing children's hospital affiliated to capital medical university
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Children' Hospital, Capital Medical University
name: Ming Ge, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bronco A, Pietrini D, Lamperti M, Somaini M, Tosi F, del Lungo LM, Zeimantz E, Tumolo M, Lampugnani E, Astuto M, Perna F, Zadra N, Meneghini L, Benucci V, Bussolin L, Scolari A, Savioli A, Locatelli BG, Prussiani V, Cazzaniga M, Mazzoleni F, Giussani C, Rota M, Ferland CE, Ingelmo PM. Incidence of pain after craniotomy in children. Paediatr Anaesth. 2014 Jul;24(7):781-7. doi: 10.1111/pan.12351. Epub 2014 Jan 28.
citation: Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. doi: 10.1097/00000542-200007000-00012.
citation: Law-Koune JD, Szekely B, Fermanian C, Peuch C, Liu N, Fischler M. Scalp infiltration with bupivacaine plus epinephrine or plain ropivacaine reduces postoperative pain after supratentorial craniotomy. J Neurosurg Anesthesiol. 2005 Jul;17(3):139-43. doi: 10.1097/01.ana.0000171730.41008.da.
citation: Ikeuchi M, Kamimoto Y, Izumi M, Fukunaga K, Aso K, Sugimura N, Yokoyama M, Tani T. Effects of dexamethasone on local infiltration analgesia in total knee arthroplasty: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2014 Jul;22(7):1638-43. doi: 10.1007/s00167-013-2367-5. Epub 2013 Jan 11.
citation: Ju NY, Cui GX, Gao W. Ropivacaine plus dexamethasone infiltration reduces postoperative pain after tonsillectomy and adenoidectomy. Int J Pediatr Otorhinolaryngol. 2013 Nov;77(11):1881-5. doi: 10.1016/j.ijporl.2013.08.037. Epub 2013 Sep 8.