Clinical Trial: The Outcome of Preoperative Administration of Single-dose Ketorolac, Non-steroidal Anti-inflammatory Drug and Placebo

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Outcome of Preoperative Administration of Single-dose Ketorolac, Non-steroidal Anti-inflammatory Drug and Placebo on Postoperative Pain in Teeth With Irreversible Pulpitis and Apical Periodontitis

Brief Summary: Aim. To compare the outcome of preoperative administration of single-dose ketorolac, non-steroidal anti-inflammatory drug and placebo on postoperative pain in teeth with irreversible pulpitis and apical periodontitis.

Detailed Summary:

The institutional review board of the Faculty od Odontology Tijuana México approved the study protocol and all the participants were treated in accordance with the Helsinki Declaration (www.cirp.org/library/ethics/helsinki). The study started in February 2016 and ended in February 2017. The main inclusion criteria were: a) A diagnosis of pulpitis confirmed by positive response to hot and cold tests and b) Clinical and radiographic evidence of symptomatic apical periodontitis. It was determined based on the clinical symptoms severe preoperative pain (VAS > 60) and severe percussion pain (VAS > 60). Confirmed by positive response to hot and cold tests. Thermal pulp testing was performed by the author, and radiographic interpretation was verified by one certified oral surgeon.

Patient selection.

Fifty-four of sixty-five patients (29 women and 25 men), 18 to 60 years of age with 54 eligible teeth consented to participate in the study. The study design is shown in Figure 1. The patients were randomly divided into three groups using a web program. The patient number and group number were recorded. Informed consent was obtained from each patient and the possible discomforts and risks were fully explained.

A total of 54 patients were divided into three groups (n = 18) according to the type of preoperative drug administrated, as follows: Group A: ketorolac 10mg (Siegfried Rhein S.A. de C.V, Mexico,DF), Group B: Diclofenac Na 50mg (Voltaren, Novartis Mexico), and Group C: A placebo (capsule filled with sugar).

A registered pharmacist compounded identical-appearing capsules of the ketorolac, Diclofenac Na and the placebo (opaque yellow size ''0'' capsules). All medications were placed in identical bottles so that they were i
Sponsor: Universidad Autonoma de Baja California

Current Primary Outcome: Level of post operative pain with administration of single-dose ketorolac, non-steroidal anti-inflammatory drug and placebo on postoperative pain in teeth with irreversible pulpitis and apical periodontitis [ Time Frame: 1 year after RCT ]

One dose administration before the RCT done


Original Primary Outcome: Same as current

Current Secondary Outcome: Level of Post operative pain after administration of single dose before RCT [ Time Frame: One year after root canal treatment ]

One dose of placebo


Original Secondary Outcome: Same as current

Information By: Universidad Autonoma de Baja California

Dates:
Date Received: March 28, 2017
Date Started: February 2, 2016
Date Completion:
Last Updated: April 14, 2017
Last Verified: April 2017