Study Finds Single-dose NSAID Best Option in Treating Post-impaction Surgical Pain

A recent randomized control trial study found that Naproxen, a non-steroidal anti-inflammatory drug, is safer and more effective in treating post-surgical pain associated with third molar extractions.

By Dr. Mehmood Asghar

Third molars are the most commonly impacted teeth that often require surgical removal. Unfortunately, these teeth also show the highest prevalence of post-operative complications such as pain, swelling, trismus, dry socket, and nerve damage. Post-operative pain is one of the most common complications of third molar extraction surgery, which significantly affects the quality of life in patients (Kim et al., 2006). A study showed that over 93% of patients experienced pain after maxillofacial procedures, where 53% of the procedures were dentofacial (Coulthard et al., 2000).

To alleviate post-surgical dental pain, dentists prescribe various medications with different levels of efficacy. For example, the opioid/acetaminophen combination is routinely used by dentists worldwide. However, concerns have been raised regarding the over-use, where non-steroidal anti-inflammatory drugs (NSAIDs) – which have fewer central nervous system and systemic side effects – can potentially work as effectively to treat post-surgical pain in the dental settings. In fact, the American Association of Oral and Maxillofacial Surgeons recommends NSAIDs as the first-line therapy for acute pain management.

To confirm this hypothesis, a study was performed to compare the efficacy of single-dose (440 mg), non-prescription naproxen sodium (NapS) with hydrocodone (10mg)/ acetaminophen (650mg) (HYD + APAP) combination treatment to treat post-impaction surgery pain in patients.

Study Design

This was a single-center, randomized, double-blinded, placebo-controlled study where a total of 221 patients were selected. Out of these, nine patients discontinued treatment or violated the study protocols. Hence, a total of 212 patients were included as the primary efficacy population.

Healthy males and non-pregnant females aged between 18 and 40 years were selected for the study. Patients having a history of hypersensitivity, those taking investigational medication or having history of malignancies or clinically significant disease, or other concomitant diseases, were excluded.

Methodology

The surgical procedure was performed under local anesthesia, using lidocaine, epinephrine, and nitrous oxide sedation.

The patients randomly received the following treatments immediately after the impaction removal procedure:

  1. Placebo
  2. NapS 440mg single dose
  3. HYD + APAP (10/650mg)

Moderate-severe pain after third molar removal was measured in the summed pain intensity difference between 0 – 12 hours (SPID0-12) post-surgery. The intensity of pain was measured using a four-point Numerical Rating Scale (NRS). The secondary evaluation endpoints were pain intensity, pain relief, time of onset of the medication, and adverse effects.

The Findings

As expected, both active treatments (NapS and HYD + APAP) were more effective in treating post-operative pain than placebo. Interestingly, it was shown that single-dose administration of NapS was significantly more effective than HYD + APAP combination therapy regarding SPID0-12 (p < 0.01).

Furthermore, NapS outperformed HYD + APAP combination therapy regarding the secondary evaluation endpoints such as total pain relief (between 0 - 6 hours and between 6 - 12 hours; p <0.05), time to rescue medication ( p < 0.001), and the duration required to reduce the pain by at least one-half (p <0.05). Overall, it was shown that the HYD + APAP combination was statistically not superior to NapS against all the primary and secondary evaluation endpoints.

It was also shown that single-dose NapS administration resulted in statistically fewer side effects (n = 2) than HYD + APAP combination therapy (n = 63) and placebo (n = 20), such as dizziness, nausea, and vomiting. This finding was as per expectations as opioids are associated with a higher number of the central nervous system and systemic adverse effects than non-prescription NSAIDs.

Clinical Implications

Opioid over-prescription is a growing concern among U.S. physicians and dentists. It’s been estimated that opioid misuse kills over 130 Americans daily. Due to the increased prevalence of complications associated with third molar extractions and the increased risk of adverse effects with an opioid prescription, continuous efforts are being made to develop safer and more effective post-surgical pain relief options.

“This study comes at a key time, as opioid addiction and overdose deaths have been declared a public health emergency in the United States,” notes M. Ted Wong, DDS, MHA, oral healthcare and dental/medical integration consultant. “The results show that NapS may be an effective, non-addictive treatment option for those undergoing dental procedures.”

The findings of this study highlight the superior efficacy of NSAIDs in treating moderate-to-severe post-surgical dental pain over opioids while minimizing the risk of adverse effects. It’s hoped that these findings will lead dental health professionals to consider safer and more effective opioid alternatives, such as NapS, which have also been recommended by the American Dental Association (2018) as the first-line therapy for treating dental pain.

References

American Dental Association. (2018). American dental association announces new policy to combat opioid epidemic. ADA News.

Coulthard, P., Haywood, D., Tai, M. A., Jackson-Leech, D., Pleuvry, B. J., & Macfarlane, T. V. (2000). Treatment of postoperative pain in oral and maxillofacial surgery. British Journal of Oral and Maxillofacial Surgery, 38(6), 588-592.

Kim, J.-C., Choi, S.-S., Wang, S.-J., & Kim, S.-G. (2006). Minor complications after mandibular third molar surgery: Type, incidence, and possible prevention. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology, 102(2), e4-e11.

Author: Dr. Mehmood Asghar is a dentist by profession and an Assistant Professor of Dental Biomaterials at the National University of Medical Sciences, Pakistan. Dr. Asghar received his undergraduate and postgraduate dental qualifications from the National University of Science and Technology (NUST). He is also currently pursuing a Ph.D. in Restorative Dentistry from Malaysia. Apart from his hectic clinical and research activities, Dr. Asghar likes to write evidence-based, informative articles for dental professionals and patients. Dr. Asghar has published several articles in international, peer-reviewed journals. His current area of research involves the use of silver-based medicaments for caries arrest and prevention.

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