Ibuprofen and Acetaminophen Versus Intranasal Ketorolac (Sprix) in an Untreated Endodontic Pain Model: A Randomized, Double-blind Investigation.

Abstract

INTRODUCTION:

Previously, ketorolac was available for primary use only via intravenous and intramuscular routes. Its availability in intranasal form offers an alternative route of administration that patients can self-administer. The purpose of this study was to compare the efficacy of intranasal ketorolac (Sprix; Egalet US Inc, Wayne, PA) with a combination of ibuprofen/acetaminophen in an acute pain model of untreated endodontic patients experiencing moderate to severe pain and symptomatic apical periodontitis.

METHODS:

Seventy patients experiencing moderate to severe pain, a pulpal diagnosis of symptomatic irreversible pulpitis or necrosis, and a periapical diagnosis of symptomatic apical periodontitis participated. Patients were randomly divided into 2 groups and received either 31.5 mg intranasal ketorolac and placebo capsules or 1000 mg acetaminophen/600 mg ibuprofen capsules and a mock nasal spray. Patients recorded perceived pain scores on a visual analog scale every 15 minutes from drug administration up to 240 minutes. The time to 50% pain relief, the first sign of pain relief, and meaningful pain relief were recorded, and the data were analyzed.

RESULTS:

A decline in reported pain was observed until 120 minutes after dosing, after which reported pain remained relatively constant. There was no significant difference between the 2 groups for the time to 50% pain relief, the first sign of pain relief, or meaningful pain relief.

CONCLUSIONS:

The effectiveness of intranasal ketorolac was not significantly different from that of a 1000 mg acetaminophen/600 mg ibuprofen combination. Intranasal ketorolac provides a nonnarcotic alternative and an additional route of medication administration to practicing clinicians.

• Authors: Kathryn Watts, Stephen Balzer, Melissa Drum, John Nusstein, Al Reader, Sara Fowler, Mike Beck
• Journal: Journal of endodontics (J Endod) Vol. 45 Issue 2 Pg. 94-98 (Feb 2019) ISSN: 1878-3554 [Electronic] United States
• PMID: 30711184 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2018 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Chemical References

• Acetaminophen
• Ibuprofen
• Ketorolac

Topics

• Acetaminophen (administration & dosage)
• Acute Pain (drug therapy, etiology)
• Administration, Intranasal
• Administration, Oral
• Adult
• Dental Pulp Necrosis (complications)
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Humans
• Ibuprofen (administration & dosage)
• Ketorolac (administration & dosage)
• Male
• Periapical Periodontitis (complications)
• Pulpitis (complications)
• Severity of Illness Index
• Treatment Outcome
• Young Adult