title: Fast-release orodispersible tramadol as analgesia in hysterosalpingography with a metal cannula or a balloon catheter.
abstract: BACKGROUND
  This study aimed to evaluate the potential benefit, in terms of pain relief, of the new oral fast-release orodispersible galvanic form of tramadol in women undergoing hysterosalpingography (HSG) with either a metal cannula or a balloon catheter.
  
  
  METHODS
  In a randomized, double-blind, placebo-controlled, 2 x 2 factorial-design trial, conducted at a single academic centre, 128 women were assigned into groups: (I) tramadol and a metal cannula, (II) tramadol and a balloon catheter, (III) placebo and a metal cannula or (IV) placebo and a balloon catheter. The primary end-point was pain registered by the patients on 10-cm visual analogue scales (VASs) at various times during and after the procedure. Secondary end-points included side effects and pain as assessed by the same physician during HSG.
  
  
  RESULTS
  The main effect of tramadol versus placebo medication (i.e. I and II versus III and IV) was a statistically significant difference (P < 0.001) in self-reported VAS of -0.91 (-1.35 to -0.47) on the absolute and -33% (-48% to -17%) on the relative scale in favour of tramadol. Likewise, there was a significant benefit for tramadol against placebo medication for physician-perceived VAS pain scores (39% relative reduction; P < 0.001). The main effect of the balloon catheter versus metal cannula (i.e. II and IV versus I and III) was a non-significant (P = 0.82) difference in patient-reported VAS of -0.05 (-0.49 to +0.39) and -2% (-21% to +17%). There were no medication-HSG device interactions and no differences in side effects.
  
  
  CONCLUSIONS
  During and after HSG, fast-release orodispersible tramadol significantly reduces pain without increasing side effects.
authors.affiliation: Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, B-1090 Brussels, Belgium. dominic.stoop@uzbrussel.be
authors.forename: D
authors.initials: D
authors.lastname: Stoop
authors.forename: M
authors.initials: M
authors.lastname: De Brucker
authors.forename: P
authors.initials: P
authors.lastname: Haentjens
authors.forename: A
authors.initials: A
authors.lastname: Talebian
authors.forename: J
authors.initials: J
authors.lastname: de Mey
authors.forename: P
authors.initials: P
authors.lastname: Devroey
mesh_terms: D000698:Analgesia; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000627:therapeutic use; D000704:Analysis of Variance; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007047:Hysterosalpingography / Q000295:instrumentation*; D010146:Pain / Q000188:drug therapy*; D010147:Pain Measurement; D018579:Patient Selection; D014147:Tramadol / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D014147:Tramadol