Efficacy of Different Drugs to Control Post Root Canal Treatment Pain

• Register: ClinicalTrials.gov
• Last refreshed on: 28 April 2015
• Main ID: NCT02417337
• Date of registration: 30/03/2015
• Prospective Registration: No
• Primary sponsor: University of Khartoum
• Public title: Efficacy of Different Drugs to Control Post Root Canal Treatment Pain
• Scientific title: Efficacy of Pain Control Following Root Canal Treatment Using Paracetamol Alone and in Combination With Three Different Non-Steroidal Anti-Inflammatory Analgesics
• Date of first enrolment: August 2012
• Target sample size: 170
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02417337
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Sudan

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Irreversible Pulpitis

Postoperative Pain

Pain

Intervention(s)

Drug: Ibuprofen

Drug: Paracetamol

Drug: Diclofenac

Drug: Mefenamic acid

Procedure: Root Canal Treatment

Primary Outcome(s)

Efficacy of different Drugs to Control Post Root Canal Treatment Pain as measured by Visual Analogue Scale. [Time Frame: 8 hours]

Secondary ID(s)

University of Khartoum

Source(s) of Monetary Support

Please refer to primary and secondary sponsors