PMID- 21679043
OWN - NLM
STAT- MEDLINE
DCOM- 20110920
LR  - 20211020
IS  - 0003-3006 (Print)
IS  - 0003-3006 (Linking)
VI  - 58
IP  - 2
DP  - 2011 Summer
TI  - A double-blind placebo-controlled comparison of a novel formulation of 
      intravenous diclofenac and ketorolac for postoperative third molar extraction 
      pain.
PG  - 73-81
LID - 10.2344/0003-3006-58.2.73 [doi]
AB  - Dyloject is a novel formulation of diclofenac intended for intravenous (IV) 
      administration. This formulation employs the solubilizing agent 
      hydroxypropyl-beta-cyclodextrin to permit bolus IV administration. The efficacy and 
      safety of 5 dose levels of IV diclofenac were compared with IV ketorolac and 
      placebo following third molar extraction. This was a single-dose, randomized, 
      double-blind, placebo- and comparator-controlled, parallel-group study. A total 
      of 353 subjects with moderate to severe pain received placebo; ketorolac 30 mg; 
      or IV diclofenac 3.75, 9.4, 18.75, 37.5, or 75 mg (N  =  51 for all groups, 
      except N  =  47 for ketorolac). The primary endpoint was total pain relief over 6 
      hours (TOTPAR6) as measured by the visual analog scale (VAS). Secondary endpoints 
      included multiple measures of pain intensity and relief; patient global 
      evaluation; and times to pain relief and rescue medication. Dropouts and adverse 
      effects (AEs) were also monitored. IV diclofenac was superior to placebo as 
      measured by TOTPAR6 (P < .0001 for all doses except 3.75 mg, for which P  =  
      .0341). IV diclofenac 3.75 mg was statistically superior to placebo for TOTPAR2 
      and TOTPAR4. IV diclofenac at both 37.5 and 75 mg was superior to placebo (P < 
      .05) at the earliest (5 minute) assessments of pain intensity and pain relief, 
      but ketorolac was not. The proportion of patients reporting 30% or greater pain 
      relief at 5 minutes was significantly greater after IV diclofenac 37.5 and 75 mg 
      than after ketorolac 30 mg or placebo. Secondary endpoints confirmed the primary 
      findings. Treatment-related AEs were generally mild to moderate and were typical 
      for nonsteroidal anti-inflammatory drugs (NSAIDs). The more rapid onset of action 
      of IV diclofenac compared with the reference injectable NSAID ketorolac suggests 
      additional clinical benefit. If confirmed in larger series, these findings may 
      improve the safety and efficacy of postoperative NSAID analgesia.
FAU - Christensen, Kyle
AU  - Christensen K
AD  - Premier Research Group, Austin, Texas, USA.
FAU - Daniels, Stephen
AU  - Daniels S
FAU - Bandy, Donald
AU  - Bandy D
FAU - Ernst, Cynthia C
AU  - Ernst CC
FAU - Hamilton, Douglas A
AU  - Hamilton DA
FAU - Mermelstein, Fred H
AU  - Mermelstein FH
FAU - Wang, Jianyuan
AU  - Wang J
FAU - Carr, Daniel B
AU  - Carr DB
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Anesth Prog
JT  - Anesthesia progress
JID - 0043533
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Drug Combinations)
RN  - 0 (beta-Cyclodextrins)
RN  - 144O8QL0L1 (Diclofenac)
RN  - 1I96OHX6EK (2-Hydroxypropyl-beta-cyclodextrin)
RN  - YZI5105V0L (Ketorolac)
MH  - 2-Hydroxypropyl-beta-cyclodextrin
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Analysis of Variance
MH  - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage
MH  - Diclofenac/*administration & dosage
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Injections, Intravenous
MH  - Kaplan-Meier Estimate
MH  - Ketorolac/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Molar, Third/surgery
MH  - Pain Measurement
MH  - Pain, Postoperative/*prevention & control
MH  - Statistics, Nonparametric
MH  - *Tooth Extraction
MH  - Young Adult
MH  - beta-Cyclodextrins/administration & dosage
PMC - PMC3198130
EDAT- 2011/06/18 06:00
MHDA- 2011/09/21 06:00
PMCR- 2011/12/01
CRDT- 2011/06/18 06:00
PHST- 2011/06/18 06:00 [entrez]
PHST- 2011/06/18 06:00 [pubmed]
PHST- 2011/09/21 06:00 [medline]
PHST- 2011/12/01 00:00 [pmc-release]
AID - 10.2344/0003-3006-58.2.73 [doi]
PST - ppublish
SO  - Anesth Prog. 2011 Summer;58(2):73-81. doi: 10.2344/0003-3006-58.2.73.