title: An open-label randomised controlled trial on the efficacy of adding intranasal fentanyl to intravenous tramadol in patients with moderate to severe pain following acute musculoskeletal injuries.
abstract: BACKGROUND
  The use of intranasal fentanyl as an alternative type of analgesia has been shown to be effective in paediatric populations and prehospital settings. There are a limited number of studies on the use of intranasal fentanyl in adult patients in emergency settings.
  
  
  METHODS
  An open-label study was conducted to evaluate the effectiveness of the addition of 1.5 mcg/kg intranasal fentanyl to 2 mg/kg intravenous tramadol (fentanyl + tramadol arm, n = 10) as compared to the administration of 2 mg/kg intravenous tramadol alone (tramadol-only arm, n = 10) in adult patients with moderate to severe pain due to acute musculoskeletal injuries.
  
  
  RESULTS
  When analysed using the independent t-test, the difference between the mean visual analogue scale scores pre-intervention and ten minutes post-intervention was 29.8 ± 8.4 mm in the fentanyl + tramadol arm and 19.6 ± 9.7 mm in the tramadol-only arm (t[18] = 2.515, p = 0.022, 95% confidence interval 1.68-18.72 mm). A statistically significant, albeit transient, reduction in the ten-minute post-intervention mean arterial pressure was noted in the fentanyl + tramadol arm as compared to the tramadol-only arm (13.35 mmHg vs. 7.65 mmHg; using Mann-Whitney U test with U-value 21.5, p = 0.029, r = 0.48). There was a higher incidence of transient dizziness ten minutes after intervention among the patients in the fentanyl + tramadol arm.
  
  
  CONCLUSIONS
  Although effective, intranasal fentanyl may not be appropriate for routine use in adult patients, as it could result in a significant reduction in blood pressure.
authors.affiliation: Emergency Medicine Department, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.
authors.forename: Keng Sheng
authors.initials: KS
authors.lastname: Chew
authors.affiliation: Emergency Medicine Department, School of Medical Sciences, Universiti Sains Malaysia, Malaysia.
authors.forename: Abdul Hafiz
authors.initials: AH
authors.lastname: Shaharudin
mesh_terms: D000281:Administration, Intranasal; D061605:Administration, Intravenous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use; D001842:Bone and Bones / Q000293:injuries*; D004244:Dizziness; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage*; D006801:Humans; D008296:Malaysia; D008297:Male; D008875:Middle Aged; D009132:Muscles / Q000293:injuries*; D059352:Musculoskeletal Pain / Q000188:drug therapy*; D059408:Pain Management; D010147:Pain Measurement; D011446:Prospective Studies; D062606:Tertiary Care Centers; D014147:Tramadol / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D014147:Tramadol; D005283:Fentanyl
keywords: fentanyl; intranasal drug administration; tramadol