Efficacy of Different Drugs to Control Post Root Canal Treatment Pain (NSAID)

August 7, 2026 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 [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.

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 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

Study Type

Interventional

Enrollment (Actual)

185

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

Description

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.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
paracetamol 1000mg
Drug: Paracetamol
NSAID
Other Names:
  • Acetaminophen
Experimental: Group II
ibuprofen 600mg + paracetamol 1000mg,
Drug: Ibuprofen
NSAID
Other Names:
  • isobutylphenyl propanoic acid
Drug: Paracetamol
NSAID
Other Names:
  • Acetaminophen
Experimental: Group III
Mefenamic acid 500mg + Paracetamol 1000mg
Drug: Paracetamol
NSAID
Other Names:
  • Acetaminophen
Drug: Mefenamic Acid
NSAID
Other Names:
  • Fenamate
Experimental: Group IV
Diclofenac K 50mg + paracetamol 1000 mg
Drug: Paracetamol
NSAID
Other Names:
  • Acetaminophen
Drug: Diclofenac
NSAID
Other Names:
  • Voltaren
Other: Group V
Placebo, no medication
Other: Placebo
empty double gelatinous capsules, having similar weight and appearance of the medications
Other Names:
  • no medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score on Numerical Rating Scale of Pain (NRS-11)
Time Frame: 8 hours
(NRS-11) numerical rating scale of pain between 0 (better) and 10 (worse) before and after treatment
8 hours
Pain Scores Before and After 8 Hours of Treatment Per Group on the VRS-4 Scale
Time Frame: 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).
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean of Pain Reduction Stratified by Sex and Jaw Type on Numerical Rating Scale (NRS-11)
Time Frame: 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)
8 hours

Collaborators and Investigators

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

Sponsor

University of Khartoum

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Estimated)

April 15, 2015

Study Record Updates

Last Update Posted (Actual)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Khartoum

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not shared

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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