Efficacy of Different Drugs to Control Post Root Canal Treatment Pain

University of Khartoum

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain; Irreversible Pulpitis; Pain

Treatments: Procedure: Root Canal Treatment; Drug: Diclofenac; Drug: Ibuprofen; Drug: Mefenamic acid; Drug: Paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT02417337

University of Khartoum

Details and patient eligibility

About

Root canal therapy will ideally eliminate post-endodontic pain but occasionally analgesics are needed to diminish the pain [1]. Development of pain after completion of root canal treatment may undermine patients' confidence in the procedure and the clinician [2]. Non-steroidal anti-inflammatory drugs are one of the most frequently taken analgesic medications for dental pain. Their popularity attributed to their efficacy in relieving pain and fever and low side effect profile at therapeutic doses [3]. Mono-therapy analgesic has a low effect on dental pain. Improvement was performance by combining analgesics with different mechanisms of action without raising any adverse effects [4], was effective in controlling moderate to severe pain. The combination of a non-steroidal anti-inflammatory drug (NSAID) and paracetamol has shown additive analgesia for treating dental pain in several studies [5,6]. Endodontic treatment with a lower prevalence of postoperative pain is usually the treatment of choice. There have been no controlled dental studies evaluating the additive effects of combining a non-steroidal anti-inflammatory drug with paracetamol. Breivik et al [6] & Menhinick et al [7] found that a combination of acetaminophen and ibuprofen was more effective than ibuprofen alone in managing postoperative pain. Aim of the present study, to evaluate the efficacy of the paracetamol when used alone and in combinations with three groups of drugs to control postoperative endodontic pain.

Full description

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 endodontics 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 (diclofenac k / paracetamol), group IV (mefenamic acid /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 based on 10-point VAS before and after treatment 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 (40-100 mm on a visual analogue scale, VAS). 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 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

Enrollment: 170 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patient reported spontaneous pain moderate to severe, ranging from 50 to 100 mm on a VAS (0-100 mm);
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 antidepresssants, carbamazepine, diuretics, or anticoagulants;
6. There was history of opioid addiction or abuse; and
7. Pregnant or nursing female patients.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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170 participants in 5 patient groups, including a placebo group

Group I

Active Comparator group

Description:

paracetamol 1000mg

Treatment:

Drug: Paracetamol

Procedure: Root Canal Treatment

Group II

Experimental group

Description:

ibuprofen 600mg + paracetamol 1000mg,

Treatment:

Drug: Ibuprofen

Drug: Paracetamol

Procedure: Root Canal Treatment

Group III

Experimental group

Description:

Mefenamic acid 500mg + Paracetamol 1000mg

Treatment:

Drug: Mefenamic acid

Drug: Paracetamol

Procedure: Root Canal Treatment

Group IV

Experimental group

Description:

Diclofenac K 50mg + paracetamol 1000 mg

Treatment:

Drug: Diclofenac

Drug: Paracetamol

Procedure: Root Canal Treatment

Group V

Placebo Comparator group

Description:

No medication

Treatment:

Procedure: Root Canal Treatment