title: Fentanyl as pre-emptive treatment of pain associated with turning mechanically ventilated patients: a randomized controlled feasibility study.
abstract: OBJECTIVE
  To compare pain incidence and changes in pain scores with fentanyl versus placebo as pre-emptive treatment during turning and 30 min post-turning in mechanically ventilated critically ill patients.
  
  
  METHODS
  We performed a randomized, double-blind, parallel-group, placebo-controlled clinical trial in the intensive care unit of a university hospital. Seventy-five mechanically ventilated patients were randomized to an intervention group (fentanyl) or a control group (placebo). Patients in the intervention group received 1 µg/kg (medical patients) or 1.5 µg/kg (surgical patients) of fentanyl 10 min before turning. Pain indicators were assessed using the behavioral pain scale. Safety was assessed by determining the frequency and severity of pre-defined adverse events. Pain was evaluated at rest (T0), at turn start and end (T1 and T2) and at 5, 15 and 30 min post-turning (T3, T4 and T5).
  
  
  RESULTS
  The two groups had similar baseline characteristics. The area under the curve for BPS values was significantly smaller in the fentanyl group than in the control group [median and interquartile range (IQR): 132 (108-150) vs. 147 (125-180); p = 0.016, respectively]. Nineteen non-serious adverse events were recorded in 14 patients, with no significant between-group differences (23 % fentanyl group vs. 14 % control group; p = 0.381).
  
  
  CONCLUSIONS
  These results suggest an intravenous bolus of fentanyl of 1 µg/kg for medical patients or 1.5 µg/kg for surgical patients reduces the incidence of turning-associated pain in critically ill patients on mechanical ventilation. ClinicalTrials.gov: NCT 01950000.
authors.affiliation: Department of Nursing Research, Hospital de la Santa Creu i Sant Pau, Sant Antoni Mª Claret, 167, 08025, Barcelona, Spain. grobleda@santpau.cat.
authors.forename: Gemma
authors.initials: G
authors.lastname: Robleda
authors.affiliation: Intensive Care Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.|Intensive Care Unit, Hospital de Tortosa Verge de la Cinta, Tarragona, Spain.
authors.forename: Ferran
authors.initials: F
authors.lastname: Roche-Campo
authors.affiliation: Intensive Care Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: Maria-Àngels
authors.initials: MÀ
authors.lastname: Sendra
authors.affiliation: Intensive Care Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Navarro
authors.affiliation: Intensive Care Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Castillo
authors.affiliation: Department of Pharmacy, Research Pharmacist, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: Ainhoa
authors.initials: A
authors.lastname: Rodríguez-Arias
authors.affiliation: Department of Pharmacy, Research Pharmacist, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: Elena
authors.initials: E
authors.lastname: Juanes-Borrego
authors.affiliation: Department of Clinical Epidemiology and Public Health, IIB Sant Pau, Barcelona, Spain.|CIBERESP, Barcelona, Spain.|Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: Ignasi
authors.initials: I
authors.lastname: Gich
authors.affiliation: Department of Clinical Epidemiology and Public Health, IIB Sant Pau, Barcelona, Spain.|CIBERESP, Barcelona, Spain.
authors.forename: Gerard
authors.initials: G
authors.lastname: Urrutia
authors.affiliation: Intensive Care Unit, Hospital Clínic i Provincial, Barcelona, Spain.
authors.forename: José M
authors.initials: JM
authors.lastname: Nicolás-Arfelis
authors.affiliation: Department of Physiological Nursing, School of Nursing, University of California, San Francisco, USA.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Puntillo
authors.affiliation: Intensive Care Unit, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Mancebo
authors.affiliation: Department of Experimental and Health Sciences, Universitat Pompeu Fabra, Barcelona, Spain.
authors.forename: Josep E
authors.initials: JE
authors.lastname: Baños
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D003422:Critical Care / Q000379:methods*; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D005283:Fentanyl / Q000627:therapeutic use*; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D055805:Moving and Lifting Patients / Q000009:adverse effects*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology*; D012121:Respiration, Artificial / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl
keywords: Behavioral pain scale; Intensive care unit; Mechanical ventilation; Pain; Pre-emptive analgesia; Turning