Cultural Adaptation and Validation of the Premature Infant Pain Profile-Revised (PIPP-R) Pain Measurement Scale: Research Protocol.

INTRODUCTION: The main objective of this study is to validate the PIPP-R scale (Premature Infant Pain Profile-Revised) for measuring neonatal pain in the Spanish hospital setting. MATERIALS AND METHODS: The original scale will be translated from English into Spanish and a consensus translation will be prepared by the research team, which will be back-translated from Spanish into English. The content validity of the Spanish version of the scale will be measured using the Delphi method. Subsequently, a multicenter observational study will be conducted to assess construct validity, internal consistency, and intra-observer and inter-observer agreement. Pain will be assessed by comparing scores for a specific non-painful procedure with those for a specific painful procedure. The sample will include 300 subjects in intensive care and intermediate care units, who will be equally distributed among the participating hospitals. The subjects will be stratified into three groups by gestational age. DISCUSSION: The original version of the PIPP-R scale is useful for objectively assessing neonatal acute and procedural pain from a gestational age of 25 weeks and over. It is important to culturally adapt the original validated scale and to test its validity and reliability in the Spanish healthcare context. The results of this study may represent significant progress in pain management.

Effect of rosuvastatin on cytokines after traumatic head injury.

OBJECT: The favorable effect of statin treatment after traumatic brain injury (TBI) has been shown in animal studies and is probably true in humans as well. The objective of this study was to determine whether acute statin treatment following TBI could reduce inflammatory cytokines and improve functional outcomes in humans. METHODS: The authors performed a double-blind randomized clinical trial in patients with moderate to severe TBI. Exclusion criteria were as follows: prior severe disability; use of modifiers of statin metabolism; multisystem trauma; prior use of mannitol, barbiturates, corticosteroids, or calcium channel blockers; isolated brainstem lesions; allergy to statins; previous hepatopathy or myopathy; previous treatment at another clinic; and pregnancy. Patients were randomly selected to receive 20 mg of rosuvastatin or placebo for 10 days. The main goal was to determine the effect of rosuvastatin on plasma levels of tumor necrosis factor-α, interleukin (IL)-1ß, IL-6, and IL-10 after 72 hours of TBI. Amnesia, disorientation, and disability were assessed 3 and 6 months after TBI. RESULTS: Thirty-six patients were analyzed according to intention-to-treat analysis; 19 patients received rosuvastatin and 17 received placebo. The best-fit mixed model showed a significant effect of rosuvastatin on the reduction of tumor necrosis factor-α levels (p = 0.004). Rosuvastatin treatment did not appear to affect the levels of IL-1ß, IL-6, and IL-10. The treatment was associated with a reduction in disability scores (p = 0.03), indicating a favorable functional outcome. Life-threatening adverse effects were not observed. CONCLUSIONS: The authors' data suggest that statins may induce an antiinflammatory effect and may promote recovery after TBI. The role of statins in TBI therapy should be confirmed in larger clinical trials.

Effect of rosuvastatin on amnesia and disorientation after traumatic brain injury (NCT003229758).

Amnesia is a common sequela following traumatic brain injury (TBI), for which there is no current treatment. Pleiotropic effects of statins have demonstrated faster recovery of spatial memory after TBI in animals. We conducted a double-blind randomized clinical trial add-on of patients with TBI (16-50 years of age), with Glasgow Coma Scale (GCS) scores of 9-13, and intracranial lesions as demonstrated by computed tomography (CT) scan. We excluded those patients with recent head injury or severe disability; administration of known drugs as modifiers of statin metabolism; multisystemic trauma; prior use of mannitol, barbiturate, corticosteroids, indomethacin or calcium antagonists; surgical or isolated lesion in brainstem; allergy to statins; previous hepatopathy or myopathy; previous management in another clinic; or pregnancy. Each patient received the same treatment and was randomly allocated to receive either rosuvastatin (RVS) or placebo over a period of 10 days. The primary outcome measures assessed were amnesia and disorientation times using Galveston Orientation Amnesia Test. Additionally, we evaluated plasma levels of interleukin (IL) 1beta, tumor necrosis factor (TNF) alpha, and IL-6, as well as disability at 3 months. We analyzed eight patients with RVS and 13 controls with similar basal characteristics. Using Cox regression analysis, administration of RVS showed a reduction of amnesia time with a hazard ratio of 53.76 (95% confidence interval [CI], 1.58-1824.64). This was adjusted for early intubation, basal leukocytes, basal Marshall and Fisher score, change of IL-1beta levels, and lesion side. IL-6 values at day 3 were increased in the RVS group (p = 0.04). No difference was detected in disability at 3 months. While statins may reduce amnesia time after TBI, possibly by immunomodulation, further trials are needed in order to confirm this positive association.