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.
OBJECTIVE
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.


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.


CONCLUSIONS
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.
Ladov
M J
MJ
Department of Oral and Maxillofacial Surgery, Robert Wood Johnson University Hospital, New Brunswick, NJ, USA.
Precheur
H V
HV
Rauch
D M
DM
Engel
P S
PS
Stern
R K
RK
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000698:Analgesia / Q000379:methods / Q000706:statistics & numerical data; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D002077:Butorphanol / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage*; D008297:Male; D008964:Molar, Third / Q000601:surgery*; D010147:Pain Measurement / Q000379:methods / Q000706:statistics & numerical data; D010149:Postoperative Pain / Q000188:drug therapy*; D012449:Safety; D013997:Time Factors; D014081:Tooth Extraction; D014095:Tooth, Impacted / Q000601:surgery*
D018712:Analgesics, Non-Narcotic; D000701:Analgesics, Opioid; D002077:Butorphanol; D007052:Ibuprofen