Role of Prophylactic Antiepileptic Therapy in the management of Clinically Diagnosed Raised Intracranial Pressures in Children: A Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1. Incidence of occurrence of acute symptomatic seizures (ASS; including Non-Convulsive Status Epilepticus) in 48 hours from admission within the 3 groups.
研究概览
简要总结
The children between 1-month to <14 years of age, who present to the Pediatric emergency Medicine Unit (PEM), AIIMS Raipur with symptomatology and clinical assessment at the end of triaging/ primary and secondary assessments suggestive of raised ICP, with parents willing for consent for the study and those fitting into the inclusion criteria would be enrolled for the study. Those with any of the exclusion criteria being met, would be excluded. Computer-generated block randomization with block size 6{2 for phenytoin treatment arm – denoted with letter P, 2 for Levetiracetam treatment arm – denoted with letter L and 2 for placebo (Normal saline) arm – denoted with letter N} will be used and an envelope concealment method shall be employed. At admission, sealed envelopes can be taken from the allocation box, kept ready in prior in the nursing desk and the researcher allocates the patient into one of the three arms and loads/ does not load with antiepileptic therapy as needed for the allocation. This is an open labelled study and there is no blinding. The routine management for raised ICP shall be continued similarly as per standard treatment guidelines and as warranted by the clinical state, for both groups.
Baseline data and demography will be collected, and patient will be followed up meticulously for various outcomes of interest as listed above at 48 hours, 7 days/ till discharge. In the event of occurrence of seizures in the control group, antiepileptic medication – Levetiracetam/ Phenytoin shall be loaded as per the physician’s discretion, and they shall be treated as per institutional protocol for ethical reasons. Intention to treat analysis shall be employed for them too. The nursing staff in PEM will be taught and informed about giving drugs P, L and N in the groups concerned and shall be made readily available in the ward stock. If the child survives up to discharge, will be followed up till 30 days (1 month) via phone call and details shall be collected. Data obtained will be entered in Excel sheets. After the study is complete, analysis of the data will be performed using intention to treat process using latest SPSS version.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children presenting to the Pediatric Emergency Medicine Unit with clinical findings consistent with raised ICP and not had h/o seizures.
- •Children already loaded elsewhere prophylactically, with appropriate standard dosing (as used in the study) of Levetiracetam/ Phenytoin and referred here; with findings consistent with raised ICP in PEM shall also be included in the concerned anti-epileptic drug arm and observed further with the maintenance dose.
排除标准
- •Known seizure disorder/ epilepsy on regular antiepileptic therapy (Those children meeting the criteria, with only febrile seizures on intermittent AED prophylaxis, will not be excluded).
- •Children with ICP who already had seizures.
- •Post cardiac arrest/ history of CPR.
结局指标
主要结局
1. Incidence of occurrence of acute symptomatic seizures (ASS; including Non-Convulsive Status Epilepticus) in 48 hours from admission within the 3 groups.
时间窗: 48 hours
2. Incidence of 48 hours mortality & reduction of 48 hours predicted mortality index from baseline prediction at admission based on PRISM 3 scores in the 3 study groups.
时间窗: 48 hours
次要结局
- 1. Seizure recurrence/ occurrence after 48 hours till discharge from the hospital/ during 1 month follow up period in 3 groups
研究者
JOVIN CHRIS ANTONY
All India Institute of Medical Sciences, Raipur