Rapydan versus Ametop. Version 1.2

• Research type

  Research Study

• Full title

  A multicentre, randomised, double blind, evaluative comparison trial of Rapydan® patch and Ametop® gel for topical anaesthesia during venous cannulation in adults admitted to hospital for day-case surgery.

• IRAS ID

  8955

• Sponsor organisation

  THE LEEDS TEACHING HOSPITALS NHS TRUST

• Eudract number

  2008-006652-22

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This research will compare two licenced pain killing preparations (Ametop versus Rapidyan). Either one of the drugs will be applied to the surface of the hand of patients attending hospital for day case surgery, prior to having a needle inserted (drip line). Following informed consent 50 patients will be allocated to Ametop group and another 50 to Rapydan group. Neither the patient nor the clinician inserting the needle will know which preparation has been used. The patient will then be asked, after needle insertion, to express any pain or discomfort they experienced during the procedure, both using a visual scoring system and being asked specific questions. Patients will also be observed until hospital discharge for any untoward reactions that may be associated with the study drug and will also be asked to report any concerns after discharge. This trial may demonstrate which preparation is most effective at preventing pain associated with needle insertion.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  09/H1307/10

• Date of REC Opinion

  23 Mar 2009

• REC opinion

  Further Information Favourable Opinion