An open-label evaluation of the efficacy and safety of Stadol NS with ibuprofen in the treatment of pain after removal of impacted wisdom teeth

Abstract

Purpose: This study evaluated the efficacy and safety of transnasal butorphanol tartrate (Stadol NS; Bristol-Myers Squibb, New York, NY) in the treatment of patients with moderate to severe pain after oral surgery for the removal of impacted third molars. Patients and Methods: In this open-label study, third molar extraction was performed on 25 male and 25 female patients. These patients were given Stadol NS nasal spray, 1 mg, administered in a single dose every 4 hours as needed. However, patients were allowed to remedicate 60 to 90 minutes after the initial dose, if necessary. They also took ibuprofen (400 mg) as concomitant medication every 4 to 6 hours for the first 48 hours. Patients recorded pain intensity on a visual analog scale, with 0 representing no pain, to 10 representing the most severe pain. Results: Stadol NS significantly reduced pain (by 50%) after third molar extraction within 15 minutes after administration. It had a high level of patient acceptance, 81% on day 1, and was well tolerated. Conclusion: The rapid onset of analgesia and long duration of action shown by Stadol NS in this study, as well as its ease of administration and high level of patient acceptance, suggest that this drug would be an excellent primary choice for the management of pain after third molar extraction and oral surgery in general. © 2000 American Association of Oral and Maxillofacial Surgeons