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Trial record 55 of 465 for:    KETOROLAC

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

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ClinicalTrials.gov Identifier: NCT03116672
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Jorge Paredes Vieyra, Universidad Autonoma de Baja California

Tracking Information
First Submitted Date  ICMJE March 28, 2017
First Posted Date  ICMJE April 17, 2017
Last Update Posted Date April 18, 2017
Actual Study Start Date  ICMJE February 2, 2016
Actual Primary Completion Date February 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03116672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Outcome of Preoperative Administration of Single-dose Ketorolac, Non-steroidal Anti-inflammatory Drug and Placebo
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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)
Masking 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, 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.

Primary Purpose: Treatment
Condition  ICMJE Pulpitis - Irreversible
Intervention  ICMJE
  • Drug: one dose ketorolac 10 mg
    Administration of ketorolac 10mg, (Dolac) 15 minutes before the clinical procedure.
    Other Name: Dolac
  • Drug: One dose Diclofenac
    Administration of diclofenac, (Diclofenaco) 15 minutes before the clinical procedure.
    Other Name: Diclofenaco
  • Drug: Placebo oral capsule
    Administration of Placebo, 15 minutes before the clinical procedure.
    Other Name: Placebo OS
Study Arms  ICMJE
  • Experimental: ketorolac 10 mg
    Administration of one dose Ketorolac 10 mg 15 minutes before treatment
    Intervention: Drug: one dose ketorolac 10 mg
  • Experimental: Diclofenac
    Administration of one dose Diclofenac 15 minutes before treatment
    Intervention: Drug: One dose Diclofenac
  • Experimental: Placebo oral capsule
    Administration of Placebo capsule 15 minutes before treatment
    Intervention: Drug: Placebo oral capsule
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2017)
3
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 10, 2017
Actual Primary Completion Date February 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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:

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03116672
Other Study ID Numbers  ICMJE One Dose 2017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Invitation to participate. Offer to the public All the clinical procedure and risks were explained to each participant.
Responsible Party Jorge Paredes Vieyra, Universidad Autonoma de Baja California
Study Sponsor  ICMJE Universidad Autonoma de Baja California
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Miguel O Osuna, DDS SECRETARIA DE SALUD DE BC
PRS Account Universidad Autonoma de Baja California
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP