Injectable Diclofenac for the prevention of post-operative dental pain

• Research type

  Research Study

• Full title

  Preliminary evaluation of the efficacy and local tolerability of Injectable Diclofenac at 5, 12.5, 25 and 50 mg/mL, administered locally prior to surgery for the prevention of post-operative pain after third molar surgery

• IRAS ID

  110345

• Contact name

  Thomas Dietrich

• Sponsor organisation

  IBSA Institut Biochimique S.A.

• Eudract number

  2012-002996-32

• Research summary

  The aim of this randomised placebo-controlled clinical trial is to investigate the safety and effcacy of an intra-mucosal injection of an established non-steroidal anti-inflammatory drug (diclofenac) at the surgical site to reduce post-operative pain and inflammation following the surgical removal of impacted third molar teeth. The study will randomise 75 patients to receive one of five doses of diclofenac (5 mg, 12.5 mg, 25 mg or 50 mg diclofenac or placebo). The study medicaton will be injected at the surgical site immediately following the administration of local anaesthesia but before surgery. Local anaesthesia and surgery will be carried out as per normal standard of care. Following removal of the impacted mandibular third molar, the patients will remain at the investigational site for 6 hours, during which time they will make repeated assessments of postoperative pain using a visual analogue scale (VAS). During the 6-hour observation period, the investigator will monitor the site of injection and surgery for local tolerability. The patients will be allowed to take normal analgesic medication (paracetamol) as rescue medication whenever they feel pain so intense to need rescue. Following the 6-hour observational period, patients will be discharged home and will make additional assessments of pain. Patients will return to the investigational site 2 days post-operatively for additional safety assessments and 1 week postoperatively for a final study visit.

• REC name

  HSC REC A

• REC reference

  12/NI/0159

• Date of REC Opinion

  7 Nov 2012

• REC opinion

  Favourable Opinion