The Outcome of Preoperative Administration of Single-dose Ketorolac, Non-steroidal Anti-inflammatory Drug and Placebo
Condition: Pulpitis - Irreversible
MeSH terms: Pulpitis
Study type: Interventional

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 description: 
      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 indistinguishable to the investigator.

      The administration of drugs and root canal treatment were performed by two different
      researchers. One assistant knew the allocation and the drug type in the capsules, but the
      operator and the patient did not know which drug type was administered.

      Patient selection was based on the following criteria: 1) The aims and requirements of the
      study were freely accepted; 2) Treatment was limited to patients in good health; 3) Patients
      with symptomatic or asymptomatic teeth with vital pulps and apical periodontitis; 4) A
      positive response to hot and cold pulp sensitivity tests; 5) Presence of sufficient coronal
      tooth structure for rubber dam isolation; 6) No prior endodontic treatment on the involved
      tooth and 7) No analgesics or antibiotics were used five days before the clinical procedures
      began.

      Exclusion criteria included the following: 1) Patients who did not meet inclusion
      requirements; 2) Patients who did not provide authorization for participation; 3) Patients
      who were younger than 16 years old; 4) Patients who were pregnant; 5) Patients who were
      diabetic; 6) Patients with a positive history of antibiotic use within the past month; 7)
      Patients whose tooth had been previously accessed or endodontically treated; 8) Teeth with
      root resorption, and 9) 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.
    

Intervention name(s): one dose ketorolac 10 mg; One dose Diclofenac; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of ketorolac 10mg, (Dolac) 15 minutes before the clinical procedure.; Administration of diclofenac, (Diclofenaco) 15 minutes before the clinical procedure.; Administration of Placebo, 15 minutes before the clinical procedure.
Other intervention name(s): Dolac; Diclofenaco; Placebo OS
Intervention MeSH terms: Diclofenac; Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pain; Diclofenac; NSAID; Ketorolac