Pain Reduction of Ibuprofen Sodium Dihydrate Alone and in Combination with Acetaminophen in an Untreated Endodontic Pain Model: A Randomized, Double-blind Investigation

Morgan Palya; Janine Matos Chevere; Melissa Drum; Sara Fowler; John Nusstein; Al Reader; Andy Ni

doi:10.1016/j.joen.2024.04.005

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:S0099-2399(24)00231-0. doi: 10.1016/j.joen.2024.04.005. Online ahead of print.

Authors

Morgan Palya¹, Janine Matos Chevere², Melissa Drum³, Sara Fowler⁴, John Nusstein⁵, Al Reader⁶, Andy Ni⁷

Affiliations

¹ Former graduate student in endodontics, The Ohio State University. She is currently practicing in Pittsburg, PA.
² Former graduate student in endodontics, The Ohio State University. She is currently practicing in Holland and Muskegon, MI.
³ Professor and Graduate Program Director, Division of Endodontics, The Ohio State University.
⁴ Associate Professor and Predoctoral Director, Division of Endodontics, The Ohio State University.
⁵ Professor and Chair, Division of Endodontics, The Ohio State University.
⁶ Emeritus Professor, Division of Endodontics, The Ohio State University. Electronic address: reader.2@osu.edu.
⁷ Assistant Professor, Division of Biostatistics, College of Public Health, The Ohio State University.

PMID: 38657900
DOI: 10.1016/j.joen.2024.04.005

Abstract

Introduction: 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.

Keywords: Acetaminophen; Endodontic Pain; Ibuprofen sodium dihydrate.