Irreversible PulpitisNCT02940405
Ketorolac Premedication for Anesthetic Efficiency of IANB & Postendodontic Pain in Teeth With Irreversible Pulpitis
A study testing Ketorolac Tromethamine in people with Irreversible Pulpitis, run by Cairo University.
Trial summary
The aim of this study to assess effect of ketorolac premedication on the effectiveness of the inferior alveolar nerve block, pretreatment and postoperative pain in patients with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Ketorolac Tromethamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-45 years old.
- Males or Females.
- Mandibular Posterior teeth with symptomatic irreversible pulpitis.
- Patients with non-contributory systemic condition.
Who cannot join
- Patients allergic to any analgesics or antibiotics or anesthetics
- Pregnant females
- If analgesics have been administrated during the past 8 hours before endodontic treatment.
- Irrestorable teeth.
Trial locations and contacts
No sites are listed yet.
Suzan AW Amin, PhD contact
About this study
Official title: Effect of Ketorolac Premedication on Anesthetic Efficiency of Inferior Alveolar Nerve Block, Pre-Treatment and Post-Endodontic Pain in Teeth With Irreversible Pulpitis: A Randomized Controlled Double Blinded Trial
The aim of this study to assess effect of ketorolac premedication on the effectiveness of the inferior alveolar nerve block, pretreatment and postoperative pain in patients with symptomatic irreversible pulpitis.
Read the detailed description
- Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 2 groups: experimental group (taking a 10 mg tablet of ketorolac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before starting treatment. The patient's pain will be assessed before local anesthetic adminstration. After 15 minutes of the initial inferior alveolar nerve block (IANB), the teeth will be examined using a cold pulp sensitivity test; in case of no or mild pain, the treatment will be initiated.
- During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated.
- Postoperative pain will be assessed 6, 12, 24 and 48 hours after treatment. The number of patients who will require rescue analgesic medication within the 48 hours postoperatively will be counted.
- Conditions
- Irreversible Pulpitis
- Being tested
- Ketorolac Tromethamine, Placebo
- Keywords
- Ketorolac Premedication, Anesthetic Efficiency, Post-Endodontic Pain, Post-operative pain, Irreversible Pulpitis, Oral premedication
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
Also called ketolac, toradol
A 10 mg tablet of the medication will be given one hour before starting the root canal treatment
PlaceboDrug
The placebo given as a tablet one hour before staring the root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| ketorolac tromethamine | Experimental | One tablet of Ketorolac tromethamine 10-mg one hour before endodontic treatment Receives: Drug: Ketorolac Tromethamine |
| placebo tablet | Placebo comparator | One tablet of a placebo one hour before endodontic treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic efficiency
Pain during endodontic treatment will be assessed using a numerical rating scale (NRS). No or mild pain response will be considered success.
Measured: Intraoperative (During endodontic treatment)
Secondary outcomes (2)
Postoperative pain
Postoperative pain will be measured using a numerical rating scale (NRS)
Measured: At 6,12, 24, 48 hours after root canal treatment
Number of patients requiring rescue analgesic.
Number of patients requiring rescue analgesic within 48 hours after endodontic treatment
Measured: Within 48 hours after endodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionOct 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laila Zakaria Ismail, Cairo University
- Investigators
- Laila Z Ismail, Postgraduate, Principal investigator, Cairo UniversitySuzan AW Amin, PhD, Study chair, Cairo UniversitySalsabeel M Ibrahim, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940405
- Sponsor's protocol ID
- CEBC-CU-2016-10-148
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Saha SG, Jain S, Dubey S, Kala S, Misuriya A, Kataria D. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. J Clin Diagn Res. 2016 Feb;10(2):ZC25-9. doi: 10.7860/JCDR/2016/16873.7195. Epub 2016 Feb 1.
PubMed 27042580Aggarwal V, Singla M, Kabi D. Comparative evaluation of effect of preoperative oral medication of ibuprofen and ketorolac on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial. J Endod. 2010 Mar;36(3):375-8. doi: 10.1016/j.joen.2009.11.010.
PubMed 20171350Sethi P, Agarwal M, Chourasia HR, Singh MP. Effect of single dose pretreatment analgesia with three different analgesics on postoperative endodontic pain: A randomized clinical trial. J Conserv Dent. 2014 Nov;17(6):517-21. doi: 10.4103/0972-0707.144574.
PubMed 25506136Jena A, Shashirekha G. Effect of preoperative medications on the efficacy of inferior alveolar nerve block in patients with irreversible pulpitis: A placebo-controlled clinical study. J Conserv Dent. 2013 Mar;16(2):171-4. doi: 10.4103/0972-0707.108209.
PubMed 23716973
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketorolac Premedication on Anesthetic Efficiency of Inferior Alveolar Nerve Block, Pre-Treatment and Post-Endodontic Pain in Teeth With Irreversible Pulpitis: A Randomized Controlled Double Blinded Trial
- ClinicalTrials.gov ID
- NCT02940405
- Acronym / sponsor ID
- CEBC-CU-2016-10-148
- Conditions
- Irreversible Pulpitis
- Keywords
- Ketorolac Premedication, Anesthetic Efficiency, Post-Endodontic Pain, Post-operative pain, Irreversible Pulpitis, Oral premedication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study to assess effect of ketorolac premedication on the effectiveness of the inferior alveolar nerve block, pretreatment and postoperative pain in patients with symptomatic irreversible pulpitis.
Detailed description
- Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 2 groups: experimental group (taking a 10 mg tablet of ketorolac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before starting treatment. The patient's pain will be assessed before local anesthetic adminstration. After 15 minutes of the initial inferior alveolar nerve block (IANB), the teeth will be examined using a cold pulp sensitivity test; in case of no or mild pain, the treatment will be initiated.
- During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated.
- Postoperative pain will be assessed 6, 12, 24 and 48 hours after treatment. The number of patients who will require rescue analgesic medication within the 48 hours postoperatively will be counted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketorolac tromethamine | Experimental | Drug: Ketorolac TromethamineOne tablet of Ketorolac tromethamine 10-mg one hour before endodontic treatment |
| placebo tablet | Placebo comparator | Drug: PlaceboOne tablet of a placebo one hour before endodontic treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18-45 years old.
- Males or Females.
- Mandibular Posterior teeth with symptomatic irreversible pulpitis.
- Patients with non-contributory systemic condition.
Key exclusion criteria (4 listed)
- Patients allergic to any analgesics or antibiotics or anesthetics
- Pregnant females
- If analgesics have been administrated during the past 8 hours before endodontic treatment.
- Irrestorable teeth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac TromethamineAlso: ketolac, toradolA 10 mg tablet of the medication will be given one hour before starting the root canal treatment | Drug | ketorolac tromethamine |
| PlaceboThe placebo given as a tablet one hour before staring the root canal treatment | Drug | placebo tablet |
Primary outcome
Anesthetic efficiency
Time frame: Intraoperative (During endodontic treatment)
Pain during endodontic treatment will be assessed using a numerical rating scale (NRS). No or mild pain response will be considered success.
2 secondary outcomes
Postoperative pain
Time frame: At 6,12, 24, 48 hours after root canal treatment
Number of patients requiring rescue analgesic.
Time frame: Within 48 hours after endodontic treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Background: PubMed 27042580Saha SG, Jain S, Dubey S, Kala S, Misuriya A, Kataria D. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. J Clin Diagn Res. 2016 Feb;10(2):ZC25-9. doi: 10.7860/JCDR/2016/16873.7195. Epub 2016 Feb 1.
- Background: PubMed 20171350Aggarwal V, Singla M, Kabi D. Comparative evaluation of effect of preoperative oral medication of ibuprofen and ketorolac on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial. J Endod. 2010 Mar;36(3):375-8. doi: 10.1016/j.joen.2009.11.010.
- Background: PubMed 25506136Sethi P, Agarwal M, Chourasia HR, Singh MP. Effect of single dose pretreatment analgesia with three different analgesics on postoperative endodontic pain: A randomized clinical trial. J Conserv Dent. 2014 Nov;17(6):517-21. doi: 10.4103/0972-0707.144574.
- Background: PubMed 23716973Jena A, Shashirekha G. Effect of preoperative medications on the efficacy of inferior alveolar nerve block in patients with irreversible pulpitis: A placebo-controlled clinical study. J Conserv Dent. 2013 Mar;16(2):171-4. doi: 10.4103/0972-0707.108209.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzan AW Amin, PhD contact
Laila Z Ismail, Postgraduate principal investigator
Cairo University
Suzan AW Amin, PhD study chair
Cairo University
Salsabeel M Ibrahim, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Ketorolac Tromethamine in people with Irreversible Pulpitis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laila Z Ismail, Postgraduate (+002 (01223487628), Laila.zakaria@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthetic efficiency (time frame: Intraoperative (During endodontic treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02940405, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.