Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment

Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment: A Randomized, Double-blind, Placebo-controlled Trial

The aim of this prospective, randomized, double-blind, clinical trial is to evaluate the effect of a preoperative, single, oral dose of aceclofenac (100 mg) on postendodontic pain at 6, 24 and 48 hours, postoperative pain at injection area at 6, 24 and 48 hours and analgesic intake after single-visit root canal treatment.

Study Overview

• Status: Completed
• Conditions: Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Drug: Aceclofenac; Other: Placebo

Detailed Description

• Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured using Heft-Parker VAS. Eligible patients will be treated in one visit.
• Patients will be randomly assigned to one of 2 groups: experimental group (taking a 100 mg of Aceclofenac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before the initiation of single-visit endodontic therapy. Each participant will receive a standard inferior alveolar nerve block injection of 1.8 ml of 2% mepivacaine with 1:100,000 epinephrine. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication.
• Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 24, and 48 hours postoperatively using Heft-Parker visual analogue scale (HP-VAS). Postoperative pain at injection area will be assessed at 6,24 and 48 hours using HP-VAS. Analgesic intake throughout the 48 hours will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients in good health (American Society of Anesthesiologists Class I or Class II).
• Patients having symptomatic irreversible pulpitis in one of their mandibular molars
• Age is 18 years or older.
• Patients who can understand Heft- Parker Visual Analogue Scales.
• Patients able to sign informed consent.

Exclusion Criteria:

• Patients allergic to aceclofenac or Mepivacaine.
• Pregnant or nursing women.
• Patients having active pain in more than one molar in the same quadrant.
• Administration of analgesics within 12 h before the administration of the study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo tablet given one hour before starting the root canal treatment
Experimental: Aceclofenac; Aceclofenac 100 mg tablet	Drug: Aceclofenac; Aceclofenac 100 mg tablet given one hour before starting the root canal treatment; Other Names: Bristaflam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postendodontic pain rate change	Postendodontic pain will be measured using Heft-Parker visual analogue scale. No or mild pain response will be considered success.	At 6, 24 and 48 hours after root canal treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain at injection area	Postoperative pain at injection area will be measured with Heft-Parker visual analogue scale. No or mild pain response will be considered success.	At 6, 24 and 48 hours after root canal treatment.
Analgesic intake	Incidence of analgesic intake	Within 48 hours after single root canal treatment.

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Praveen R, Thakur S, Kirthiga M. Comparative Evaluation of Premedication with Ketorolac and Prednisolone on Postendodontic Pain: A Double-blind Randomized Controlled Trial. J Endod. 2017 May;43(5):667-673. doi: 10.1016/j.joen.2016.12.012. Epub 2017 Mar 17.
• Attar S, Bowles WR, Baisden MK, Hodges JS, McClanahan SB. Evaluation of pretreatment analgesia and endodontic treatment for postoperative endodontic pain. J Endod. 2008 Jun;34(6):652-5. doi: 10.1016/j.joen.2008.02.017. Epub 2008 Apr 2.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: October 29, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: pain; irreversible pulpitis; Aceclofenac
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Aceclofenac
• Other Study ID Numbers: CEBD-CU-2015-5-146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No