Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery
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Randomized Controlled Trial Comparative Study
Comparison of equiosmolar dose of hyperosmolar agents in reducing intracranial pressure-a randomized control study in pediatric traumatic brain injury.
There are no comparative studies available for hyperosmolar therapy in children. The present study is a prospective open label randomized control trial to compare the effect of equiosmolar doses of mannitol and hypertonic saline in reducing intracranial pressure in children who sustained severe traumatic brain injury. ⋯ Both mannitol and hypertonic saline were equally effective for treatment of raised intracranial pressure in children with severe traumatic brain injury.
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Randomized Controlled Trial Multicenter Study Comparative Study
The International Infant Hydrocephalus Study: concept and rational.
During the recent meetings of the International Study Group on Neuroendoscopy and the International Society for Pediatric Neurosurgery, the consensus view emerged that there is a need to assess the value and efficacy of neuroendoscopic procedures against shunting in a scientific manner, to resolve long-lasting debates on the subject. ⋯ It is hoped that the trial will not only provide answers to unsettled debates on the value of neuroendoscopy but also create a network of collaborating pediatric neurosurgeons for future initiatives.
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Randomized Controlled Trial Clinical Trial
A randomized trial of very early decompressive craniectomy in children with traumatic brain injury and sustained intracranial hypertension.
The object of our study was to determine, in children with traumatic brain injury and sustained intracranial hypertension, whether very early decompressive craniectomy improves control of intracranial hypertension and longterm function and quality of life. ⋯ All children were managed from admission onward according to a standardized protocol for head injury management. Children with raised intracranial pressure (ICP) were randomized to standardized management alone or standardized management plus cerebral decompression. A decompressive bitemporal craniectomy was performed at a median of 19.2 h (range 7.3-29.3 h) from the time of injury. ICP was recorded hourly via an intraventricular catheter. Compared with the ICP before randomization, the mean ICP was 3.69 mmHg lower in the 48 h after randomization in the control group, and 8.98 mmHg lower in the 48 hours after craniectomy in the decompression group (P=0.057). Outcome was assessed 6 months after injury using a modification of the Glasgow Outcome Score (GOS) and the Health State Utility Index (Mark 1). Two (14%) of the 14 children in the control group were normal or had a mild disability after 6 months, compared with 7 (54%) of the 13 children in the decompression group. Our conclusion was that when children with traumatic brain injury and sustained intracranial hypertension are treated with a combination of very early decompressive craniectomy and conventional medical management, it is more likely that ICP will be reduced, fewer episodes of intracranial hypertension will occur, and functional outcome and quality of life may be better than in children treated with medical management alone (P=0.046; owing to multiple significance testing P <0.0221 is required for statistical significance). This pilot study suggests that very early decompressive craniectomy may be indicated in the treatment of traumatic brain injury.
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Randomized Controlled Trial Comparative Study Clinical Trial
Preemptive analgesia with tramadol and fentanyl in pediatric neurosurgery.
Preemptive analgesia is based on administration of an analgesic before a painful stimulus generates, so as to prevent the subsequent rebound mechanism. Tissue injury results in disruption of the processing mechanisms of noxious stimuli afferent to the CNS (central nervous system) by way of an increase of inputs in the spinal cord. These reactions may be reduced by the administration of opioids. ⋯ Tramadol efficacy seems to be better when it is administered in continuous infusion; this treatment modality also leads to fewer adverse effects. Fentanyl, in contrast, proved to be superior to tramadol in the treatment of postoperative pain. In conclusion, preemptive analgesia is a valid technique for the treatment of acute pain in children undergoing major neurosurgical operations.
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Randomized Controlled Trial Clinical Trial
Prospective randomized cooperative medulloblastoma trial (MED 84) of the International Society of Paediatric Oncology (SIOP) and of the (German) Society of Paediatric Oncology (GPO).
This international, prospective, randomised therapeutic study is based on previous, separate studies of the two societies. The study asks two principal questions: Is it possible to improve the results of therapy by inserting, between surgery and post-operative irradiation, an intensive course of chemotherapy consisting of vincristine, procarbazine and methotrexate, followed by citrovorum factor rescue? In "low risk" patients (i.e. those with macroscopically "complete" resection and absence of metastases at diagnosis), can the radiotherapy to CNS areas outside the primary tumour site be reduced by 10 Gy with the aim of reducing late sequelae of irradiation but without compromising survival results? The study also aims at standardising diagnostic methods, neurosurgical procedure and radiotherapeutic technique employed in this tumour. For statistical reasons, results can only be disclosed after the end of the recruitment phase. It is intended to include approximately 350 patients in the study, which is planned to continue until the end of 1988.