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

NCT03116672 | Completed DMC

• 1 other identifier: One Dose 2017
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis - Irreversible

Keywords

pain; Diclofenac; NSAID; Ketorolac

Outcome Measures

Primary Outcomes (1)

• 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

  One dose administration before the RCT done

  1 year after RCT

Secondary Outcomes (1)

• Level of Post operative pain after administration of single dose before RCT

  One year after root canal treatment

Study Arms (3)

ketorolac 10 mg

EXPERIMENTAL

Administration of one dose Ketorolac 10 mg 15 minutes before treatment

Drug: one dose ketorolac 10 mg

Diclofenac

EXPERIMENTAL

Administration of one dose Diclofenac 15 minutes before treatment

Drug: One dose Diclofenac

Placebo oral capsule

EXPERIMENTAL

Administration of Placebo capsule 15 minutes before treatment

Drug: Placebo oral capsule

Interventions

one dose ketorolac 10 mg DRUG

Administration of ketorolac 10mg, (Dolac) 15 minutes before the clinical procedure.

Also known as: Dolac

ketorolac 10 mg

One dose Diclofenac DRUG

Administration of diclofenac, (Diclofenaco) 15 minutes before the clinical procedure.

Also known as: Diclofenaco

Diclofenac

Placebo oral capsule DRUG

Administration of Placebo, 15 minutes before the clinical procedure.

Also known as: Placebo OS

Placebo oral capsule

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient selection was based on the following criteria:
• The aims and requirements of the study were freely accepted;
• Treatment was limited to patients in good health;
• Patients with symptomatic or asymptomatic teeth with vital pulps and apical periodontitis;
• A positive response to hot and cold pulp sensitivity tests;
• Presence of sufficient coronal tooth structure for rubber dam isolation;
• No prior endodontic treatment on the involved tooth and
• No analgesics or antibiotics were used five days before the clinical procedures began.

You may not qualify if:

• Patients who did not provide authorization for participation;
• Patients who were younger than 16 years old;
• Patients who were pregnant;
• Patients who were diabetic;
• Patients with a positive history of antibiotic use within the past month;
• Patients whose tooth had been previously accessed or endodontically treated;
• Teeth with root resorption, and
• Immature/open apex, or a root canal in which patency of the apical foramen could not be established were all excluded from the study. Teeth with periodontal pockets deeper than 4 mm, or the presence of a periapical radiolucency more than 2 cm diameter also were excluded of the study.

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Jose Clemente

Tijuana, Estado de Baja California, 22000, Mexico

Location

Related Publications (1)

• Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.

  PMID: 22892729 RESULT

MeSH Terms

Conditions

Pain

Interventions

Ketorolac; Diclofenac

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Miguel O Osuna, DDS

  SECRETARIA DE SALUD DE BC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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 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: Administration of ketorolac 10mg, Group B: Administration of Diclofenac Na 50mg, and Group C: A placebo (capsule filled with sugar). After 15 minutes each participant received the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. PhD

Model Details: 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 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.

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 17, 2017
• Study Start: February 2, 2016
• Primary Completion: February 6, 2017
• Study Completion: February 10, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)