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The Addition of Acetaminophen to Ibuprofen Sodium Dihydrate (ISD) Showed No Significant Differences From ISD Alone in Controlling Untreated Endodontic Pain
abstract
This abstract is available on the publisher's site.
Access this abstract now Full Text Available for ClinicalKey SubscribersINTRODUCTION
Most pain studies have been based on a post-surgical, third molar model using ibuprofen (IBU)/acetaminophen (APAP). Studies have found quicker onset of pain relief with a newer formulation of IBU - ibuprofen sodium dihydrate (ISD). The purpose of this study was to compare pain reduction of ISD/APAP to ISD in an acute endodontic pain model of untreated patients experiencing moderate to severe pain with symptomatic apical periodontitis.
METHODS AND MATERIALS
In this double-blind randomized study, 64 adult emergency patients in acute moderate to severe pain, a pulpal diagnosis of symptomatic irreversible pulpitis or necrosis, and symptomatic apical periodontitis participated. Each patient randomly received either one dose of 768 mg ISD/1000 mg APAP or one dose 768 mg ISD. Pain intensity scores were recorded every 15 minutes over 240 minutes using the Heft-Parker VAS along with time to first sign of pain relief, time to meaningful pain relief, and time to 50% pain relief also recorded. The data were analyzed statistically.
RESULTS
Both ISD and ISD/APAP groups showed a progressive decrease in pain from baseline to 120 minutes after medication administration. Afterwards, a relative plateau was seen in the patients' pain. There was no difference in the VAS scores between the ISD and ISD/APAP at any given time point, time to first sign of pain relief, time to meaningful pain relief, and time to 50% pain relief.
CONCLUSIONS
The addition of APAP to ISD for pain control in an untreated endodontic pain model did not differ significantly from ISD alone.
Additional Info
Disclosure statements are available on the authors' profiles:
Pain Reduction of Ibuprofen Sodium Dihydrate Alone and in Combination with Acetaminophen in an Untreated Endodontic Pain Model: A Randomized, Double-blind Investigation
J Endod 2024 Apr 22;[EPub Ahead of Print], M Palya, JM Chevere, M Drum, S Fowler, J Nusstein, A Reader, A NiFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Endodontic pain is related to the inflammatory conditions of pulp and periapical tissues caused by bacterial byproducts, cytokine activation, and related mediators. Recent advances in ibuprofen formulations such as ibuprofen sodium dihydrate (ISD) has gained attention owing to a faster onset of pain relief, as this drug reaches to a higher plasma concentration in a very short period. A recent study by Palya et al in 2024 evaluated the rate of pain reduction with the use of ISD plus acetaminophen (N-acetyl-p-aminophenol; APAP) versus ISD alone in the management of an acute endodontic pain model of untreated patients experiencing moderate to severe pain with symptomatic apical periodontitis. This randomized double-blind clinical trial method recruited 64 patients aged 18 to 65 years with pain (VAS score, >54 mm). Corah Dental Anxiety Scale scores were compared between the ISD and ISD/APAP groups for age, weight, sex, and initial pain levels. Statistical analysis was performed with the Wilcoxon Rank Sum Test. The results of this study indicated that both the ISD and ISD/APAP groups experienced a progressive decrease in pain intensity from baseline to 120 minutes after medication administration. Additionally, this study showed no significant difference in the VAS scores between the two study groups at any given time point. Interestingly, this study also noted that a total of 5 patients in the ISD group and 9 in the ISD/APAP group did not achieve 50% pain relief from the medication; this may be because these patients might not have achieved complete pain relief from over-the-counter medications. This study also found that adding APAP to ISD provided no additional benefit for pain control. It is interesting to note that, with the use of ISD, the time to the first sign of pain relief was 43 ± 24 minutes, which is faster than that of other ibuprofen formulations. ISD with a half-life ranging between 1.8 and 2.0 hours and APAP with a half-life ranging between 2.0 and 2.5 hours provide pain relief for up to approximately 120 minutes. In conclusion, more studies are needed to confirm the effectiveness of ISD in the management of postoperative endodontic pain after endodontic intervention.