Remifentanil and Fentanyl in Dental Surgery (REFEDS)
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study was a prospective comparative study. The purpose of this study was to investigate
      the hypothesis whether remifentanil compared to fentanyl can induce less inflammatory and
      stress response to the day-case dental surgery in Persons with special needs (PSN). Secondary
      aims were to investigate comparatively their effect on patients intraoperative hemodynamic
      response and postoperative analgesia.
    

Detailed description: 
      The study included 46 adult patients with cognitive impairment who underwent day-case dental
      surgery under general anesthesia with propofol aiming to keep a BIS-values range between
      40-45. Nasal tracheal intubation was performed in all patients while neuromuscular blockade
      was achieved by rocuronium 0.6 mg/kg iv and repetitive doses of rocuronium of 10 mg iv, if
      needed.

      Patients were randomly allocated receive for intraoperative analgesia either fentanyl 50 μg
      iv bolus (group F, n=23) or continuous infusion of remifentanil 0.5-1 μg/kg/min (group R,
      n=23). Randomization was performed using using a computer-generated randomization schedule.

      Intraoperatively, patients in both groups received IV granisetron 3 mg, methylprednisolone
      125 mg and clindamycin 600 mg, while atropine 0.02 mg/kg and neostigmine (0.05 mg/kg) was
      administered to to reverse neuromuscular blockade. Intraoperative monitoring included
      non-invasive measurement of arterial blood pressure, electrocardiogram, pulse oxymetry,
      capnography and Bispectral Sedation Index (BIS®).

      Postoperatively, patients remained under surveillance in the post-anesthesia care unit [PACU]
      for 3 h. Postoperative pain was assessed for the first 12 postoperative hours, at 30 min
      time-intervals for the first 3 hours, and every 3 hours thereafter by an independent
      observer, blinded to the study group, using the Wong-Baker faces pain rating scale (0-6). If
      pain scores were ≥3 a rescue dose of paracetamol 12.5 mg/kg iv was administered.

      Inflammation markers and stress hormones [cortisol, Tumor necrosis factor (TNF-a),
      substance-P, melatonin and β-endorphin] were measured in each patient before induction of
      anesthesia, after tracheal intubation and at the end of operation.

      Statistical Analysis was performed using Kolmogorov-Smirnov test, Student's unpaired t-test
      or Repeated Measures ANOVA with Holm's post-hoc analysis appropriately. A p value less than
      0.05 was considered statistically significant.
    

Intervention name(s): Remifentanil; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Intraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention.; Fentanyl 50 μg iv bolus at the induction of anesthesia and before the start of surgery.
Other intervention name(s): Ultiva; FNT
Intervention MeSH terms: Fentanyl; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: remifentanil; fentanyl; dental surgery