NCT03335007

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Symptomatic Irreversible Pulpitis

Interventions

Type	Name	Description
DRUG	Aceclofenac	Aceclofenac 100 mg tablet given one hour before starting the root canal treatment
OTHER	Placebo	Placebo tablet given one hour before starting the root canal treatment

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2017-11-07
• Last updated: 2017-11-07

Locations

1 site across 1 country: Egypt