PMID- 32259416
OWN - NLM
STAT- MEDLINE
DCOM- 20200409
LR  - 20220531
IS  - 0894-8275 (Print)
IS  - 0894-8275 (Linking)
VI  - 33
IP  - 2
DP  - 2020 Apr
TI  - Efficacy and safety of naproxen sodium 440 mg versus acetaminophen 600 mg/codeine 
      phosphate 60 mg in the treatment of postoperative dental pain.
PG  - 106-112
AB  - PURPOSE: Two studies evaluated the efficacy and safety of a single dose of 
      naproxen sodium 440 mg (NS) compared to the combination of acetaminophen 600 mg 
      and codeine phosphate 60 mg (AC) in subjects with postoperative dental pain. 
      METHODS: The two studies were single center, randomized, double-blind and 
      double-dummy trials. In both studies, subjects were randomized into one of the 
      following three treatments in a 2:2:1 ratio, respectively: NS, AC, or placebo 
      (PBO). Subjects were administered study medication when they had at least 
      moderate pain following the surgical removal of three or four impacted molars, at 
      least one of which was a mandibular partial or complete bony impaction. Efficacy 
      assessments were completed over an 8-hour evaluation period. The co-primary 
      efficacy assessments in both studies were time-weighted sum of categorical pain 
      intensity differences over 4 hours (SPID4) and time-weighted sum of pain relief 
      scores over 4 hours (TOTPAR4). Other efficacy assessments such as summed scores 
      over 8 hours, time to onset of relief, time to rescue medication and global 
      rating of medication were also assessed. RESULTS: In Study 1, there were 225 
      subjects evaluated for efficacy, and 228 evaluated for safety. In Study 2, there 
      were 230 subjects evaluated for efficacy and safety. In both studies, NS and AC 
      were significantly better than placebo for almost all efficacy measures. In Study 
      1, NS was significantly superior to AC for all summed efficacy scores over 4 and 
      8 hours except for SPID4. NS was also superior to AC for most individual time 
      point scores from 3 through 8 hours, as well as for the time to taking rescue 
      medication. Both actives had a similar onset of effect. The incidence of adverse 
      events (AEs) was significantly higher in the AC group compared to NS and PBO. The 
      most frequently reported AEs with AC were gastrointestinal (GI) and nervous 
      system events. In Study 2, there were no statistically significant differences 
      between the two active treatments for any summed efficacy score, except for 
      TOTPAR8, where NS was significantly better than AC. NS was significantly better 
      than AC for individual pain relief time point scores from 3 through 8 hours and 
      significantly better for individual pain intensity difference scores from 5 
      through 8 hours. AC had a significantly faster onset of effect compared to NS, 
      but NS had a significantly longer time to rescue compared to AC. Nervous system 
      AEs (dizziness and somnolence) were reported significantly more frequently with 
      AC compared to NS. In conclusion, Both NS and AC are effective in the relief of 
      postoperative dental pain. NS provided comparable to superior relief vs. AC and 
      its analgesic effects lasted significantly longer. NS was well tolerated and 
      resulted in a lower rate of AEs than AC. CLINICAL SIGNIFICANCE: In 2017, the US 
      Department of Human Health Services declared a public health emergency to address 
      the national opioid crisis. Since dentists are among the most common specialty 
      groups prescribing opioids, these studies show that NSAIDs (such as naproxen 
      sodium) are effective analgesics for relieving postoperative pain.
CI  - Copyright(c)American Journal of Dentistry.
FAU - Cattry, Eishdeep
AU  - Cattry E
AD  - Post-Doctoral Medical Affairs Fellow at Bayer HealthCare LLC, affiliated with 
      Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, 
      Piscataway, NJ, USA, eishdeep.cattry.ext@bayer.com.
FAU - Troullos, Emanuel
AU  - Troullos E
AD  - former employee, Bayer HealthCare LLC, Whippany, NJ, USA.
FAU - Paredes-Diaz, Alberto
AU  - Paredes-Diaz A
AD  - Bayer HealthCare LLC, Whippany, NJ, USA.
LA  - eng
PT  - Clinical Trial
PT  - Randomized Controlled Trial
PL  - United States
TA  - Am J Dent
JT  - American journal of dentistry
JID - 8806701
RN  - 362O9ITL9D (Acetaminophen)
RN  - 57Y76R9ATQ (Naproxen)
RN  - UX6OWY2V7J (Codeine)
MH  - *Acetaminophen
MH  - *Codeine
MH  - Dental Care
MH  - Double-Blind Method
MH  - Humans
MH  - Naproxen
MH  - *Pain, Postoperative
COIS- Dr. Cattry and Dr. Paredes-Diaz are employees, and Dr. Troullos was an employee 
      of Bayer HealthCare LLC. Bayer HealthCare LLC funded the project.
EDAT- 2020/04/08 06:00
MHDA- 2020/04/10 06:00
CRDT- 2020/04/08 06:00
PHST- 2020/04/08 06:00 [entrez]
PHST- 2020/04/08 06:00 [pubmed]
PHST- 2020/04/10 06:00 [medline]
PST - ppublish
SO  - Am J Dent. 2020 Apr;33(2):106-112.