Efficacy of Different Drugs to Control Post Root Canal Treatment Pain

April 14, 2015 updated by: Dr. Wail Elzaki, University of Khartoum

Efficacy of Pain Control Following Root Canal Treatment Using Paracetamol Alone and in Combination With Three Different Non-Steroidal Anti-Inflammatory Analgesics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sudan
      • Khartoum, Sudan, 111-11
        • University of Khartoum, Faculty of Dentistry,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group I
paracetamol 1000mg
Drug: Paracetamol
Procedure: Root Canal Treatment
A standardized endodontic procedures performed.
Other Names:
  • Endodontic treatment
EXPERIMENTAL: Group II
ibuprofen 600mg + paracetamol 1000mg,
Drug: Paracetamol
Drug: Ibuprofen
Procedure: Root Canal Treatment
A standardized endodontic procedures performed.
Other Names:
  • Endodontic treatment
EXPERIMENTAL: Group III
Mefenamic acid 500mg + Paracetamol 1000mg
Drug: Paracetamol
Procedure: Root Canal Treatment
A standardized endodontic procedures performed.
Other Names:
  • Endodontic treatment
Drug: Mefenamic acid
EXPERIMENTAL: Group IV
Diclofenac K 50mg + paracetamol 1000 mg
Drug: Paracetamol
Drug: Diclofenac
Procedure: Root Canal Treatment
A standardized endodontic procedures performed.
Other Names:
  • Endodontic treatment
PLACEBO_COMPARATOR: Group V
No medication
Procedure: Root Canal Treatment
A standardized endodontic procedures performed.
Other Names:
  • Endodontic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of different Drugs to Control Post Root Canal Treatment Pain as measured by Visual Analogue Scale.
Time Frame: 8 hours
The patients were asked to make entries on the VAS (numerical score) every hour for the first 4 hours after taking the medication and then every 2 hours following that; a total of six entries over 8 hours.
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Khartoum

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (ESTIMATE)

April 15, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Khartoum

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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