Efficacy of Different Drugs to Control Post Root Canal Treatment Pain

Background: Management of pain is challenging part of dental treatment; sometimes pain is a major postoperative symptom after many dental procedures especially for endodontics. The aim of the present randomized clinical trial was to investigate the efficacy of using paracetamol alone and three combinations of non-steroidal anti-inflammatory drugs with paracetamol, to control postoperative endodontic pain.

Methodology: 185 patients who had anterior or premolar teeth with irreversible pulpitis without any signs and symptoms of apical periodontitis and with moderate to severe pain. Patients were divided by allocation randomization into five groups. Four experimental groups receiving different medication; group I (single dose of paracetamol); group II (ibuprofen / paracetamol); group III (mefenamic acid /paracetamol), group IV (diclofenac k / paracetamol) and group V (no medication group). The groups received the medication after the first appointment where the pulp removed, and canals fully prepared. Pain intensity was scored by using both verbal rating scale (VRS-4) and numerical rating scale (NRS-11). The pain scores were recorded before the initial endodontic therapy for up to 8 hours postoperatively. Sign test used for comparing pain score before and after treatment. This randomized control clinical trial was conducted on patients who were considered potential candidates if they had moderate to severe spontaneous pain of odontogenic origin (ranging from 4-10 score based on the numerical rating scale (NRS-11)). Patients were selected from those attending the Conservative dentistry clinics in both the University and the Teaching Hospital Emergency Clinic.

The medications were prepared in the laboratories of faculty of Pharmacy. Four groups of medications were prepared and a placebo as follows; Group I: paracetamol 1000mg Group II: ibuprofen 600mg + paracetamol 1000mg, Group III: Mefenamic acid 500mg + Paracetamol 1000mg Group IV: Diclofenac K 50mg + paracetamol 1000 mg Group V: Placebo

• Paracetamol (Drug), also known as Acetaminophen: NSAID
• Ibuprofen (Drug), also known as isobutylphenyl propanoic acid: NSAID
• Mefenamic Acid (Drug), also known as Fenamate: NSAID
• Diclofenac (Drug), also known as Voltaren: NSAID
• Placebo (Other), also known as no medication: empty double gelatinous capsules, having similar weight and appearance of the medications

Primary outcomes

• Pain Scores Before and After 8 Hours of Treatment Per Group on the VRS-4 Scale [8 hours]: Pain was recorded in the verbal rating scale-4 (VRS-4 scale) before and after 8 hours of medication. The VRS-4 Scale has four categories of pain scores: no pain is the minimum (better outcome), slight pain, moderate pain, and severe pain score is the maximum (worse outcome).
• Pain Score on Numerical Rating Scale of Pain (NRS-11) [8 hours]: (NRS-11) numerical rating scale of pain between 0 (better) and 10 (worse) before and after treatment

Secondary outcomes

• Mean of Pain Reduction Stratified by Sex and Jaw Type on Numerical Rating Scale (NRS-11) [8 hours]: Numerical rating scale (NRS-11), (0 better/the least pain score to 10 worse/the maximum pain score), , was done for sex (male or female) and jaw type (maxilla or mandible)

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

Inclusion Criteria:

1. Spontaneous pain moderate to severe on the verbal rating scale (VRS-4), ranging from 4-10 score based on the numerical rating scale (NRS-11).
2. Adult patients presented for emergency endodontic treatment with a symptomatic maxillary or mandibular tooth (anterior and premolar) with a pulpal diagnosis of Irreversible pulpitis and normal periapex.
3. Patient choose to have root canal treatment for pain of endodontic origin.
4. The patient presented with American Society of Anesthesiologists (ASA) I or II medical history (ASA 1963).
5. The patient had read and thoroughly understood the pain score level sheet

Exclusion Criteria:

1. Patients below 18 years of age;
2. Analgesic taken within the last 4 hours;
3. History of allergy to NSAIDs, paracetamol or local anaesthetics;
4. History of uncontrolled systemic disease \[gastrointestinal (GI) disorders, oesophageal reflux, active asthma, decreased hepatic function, haemorrhagic disorders, or poorly controlled diabetes mellitus\].
5. Patients currently taking opioids, monoamine oxidase inhibitors, tricyclic antidepressants, carbamazepine, diuretics, or anticoagulants;
6. There was history of opioid addiction or abuse; and
7. Pregnant or nursing female patients.

Participant flow

Outcome results

• Pain Scores Before and After 8 Hours of Treatment Per Group on the VRS-4 Scale (Primary), Count of participants, Participants: Group I 0; Group II 0; Group III 0; Group IV 0; Group V 0 (p 0.771)
• Pain Score on Numerical Rating Scale of Pain (NRS-11) (Primary), Median, score on a scale: Group I 8 (0 to 10); Group II 8 (0 to 10); Group III 8 (0 to 10); Group IV 8 (0 to 10); Group V 8 (0 to 10) (p 0.000)
• Mean of Pain Reduction Stratified by Sex and Jaw Type on Numerical Rating Scale (NRS-11) (Secondary), Mean, score on a scale: Group I 3.8 (0 to 10); Group II 1 (0 to 10); Group III 0.4 (0 to 10); Group IV 0.43 (0 to 10); Group V 1.94 (0 to 10) (p 0.000)

Adverse events

Time frame: 2 years

Serious adverse events by term

Other adverse events by term

Limitations and caveats: One limitation was the time frame for the analysis of pain; more information would have been available if there were a 24-hour outcome line

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• Results publication: Keiser K, Hargreaves K.Building effective strategies for the management of endodontic pain. Endodontic Topics, Volume 3, Issue 1, pages 93-105, November 2002
• Results publication: Menhinick KA, Gutmann JL, Regan JD, Taylor SE, Buschang PH. The efficacy of pain control following nonsurgical root canal treatment using ibuprofen or a combination of ibuprofen and acetaminophen in a randomized, double-blind, placebo-controlled study. Int Endod J. 2004 Aug;37(8):531-41. doi: 10.1111/j.1365-2591.2004.00836.x. PMID 15230906
• Results publication: Elzaki WM, Abubakr NH, Ziada HM, Ibrahim YE. Double-blind Randomized Placebo-controlled Clinical Trial of Efficiency of Nonsteroidal Anti-inflammatory Drugs in the Control of Post-endodontic Pain. J Endod. 2016 Jun;42(6):835-42. doi: 10.1016/j.joen.2016.02.014. Epub 2016 Apr 12. PMID 27080115

• Neamat Abubakr, BDS,MDSc,PhD, Study director, Faculty of Dentistry, University of Khartoum