Pretreatment Aceclofenac Effect on Pain and Analgesic Intake After Endodontic Treatment

Symptomatic Irreversible Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335007
• Other study ID #: CEBD-CU-2015-5-146
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 29, 2017
• Last updated: November 6, 2017
• Start date: May 2015
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Analgesic intake	Incidence of analgesic intake	Within 48 hours after single root canal treatment.