Root canal pain relief: does adding NSAIDs to paracetamol help?
NCT ID NCT02417337
First seen Jun 26, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This study looked at how well paracetamol alone or combined with different NSAIDs (ibuprofen, mefenamic acid, or diclofenac) controls pain after root canal treatment. 185 adults with severe tooth pain took part. The goal was to see if combining drugs works better than paracetamol alone for easing post-treatment pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs) including ibuprofen, mefenamic acid, and diclofenac
- What this could lead to
- If successful, this could point toward a more effective pain relief strategy after root canal treatment, reducing the need for stronger medications.
- What could go wrong
- This is a small, completed Phase 2 trial, so results may not apply to all patients. Combining drugs can increase side effects, and the study did not test long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
185 people
The number who actually took part.
- Start date
-
Aug 2012
- Finished
-
Jan 2015
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Khartoum, Faculty of Dentistry,
Khartoum, 111-11, Sudan
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