Irreversible Pulpitis, Pain, Postoperative Pain
Conditions
Brief summary
Root canal therapy will ideally eliminate post-endodontic pain but occasionally analgesics are needed to diminish the pain \[Owatz et al 2007\]. Development of pain after completion of root canal treatment may undermine patients' confidence in the procedure and the clinician \[Albashaireh and Alnegrish 1998\]. 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 \[Attar et al 2008\]. 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 \[Mehlisch 2002\], 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 \[Breivik et al1999, Keiser and Hargreaves 2002\]. 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 al1999 & Menhinick et al 2004 found that a combination of acetaminophen and ibuprofen was more effective than ibuprofen alone in managing postoperative pain \[Breivik et al1999 & Menhinick et al 2004\]. 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.
Detailed 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 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
Interventions
NSAID
NSAID
NSAID
NSAID
empty double gelatinous capsules, having similar weight and appearance of the medications
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Sudan
Contacts
Faculty of Dentistry, University of Khartoum
Participant flow
Recruitment details
The sample was made up of patients attending the clinics of the Faculty of Dentistry, University of Khartoum and the Khartoum Teaching Hospital emergency clinic, which were the setting and location of the trial. The clinical trial dates of recruitment was between August 2012 and August 2014.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 170 Participants |
| Age, Continuous | 33 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment Sudan | 34 participants |
| Sex: Female, Male Female | 104 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 33 | 0 / 34 | 0 / 35 | 0 / 34 |
| other Total, other adverse events | 0 / 34 | 0 / 33 | 0 / 34 | 0 / 35 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 33 | 0 / 34 | 0 / 35 | 0 / 34 |