Ignite Creation Date:
2024-05-06 @ 9:12 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02923687
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2016-09-29
Brief Title:
Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain
Sponsor:
Azad University of Medical Sciences
Organization:
Azad University of Medical Sciences
Study Overview
Official Title:
Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective The aim of this study is to evaluate premedication with ketorolac infiltration on post endodontic pain in patients with symptomatic irreversible pulpitis
Design Randomized double blind clinical trial
Setting and conduct Sixty adult volunteers with including criteria will be divided into two groups n30 based on random table All patients will receive standard inferior alveolar nerve block of 2 lidocaine with 1800000 epinephrine and supplemental buccal infiltration of 09 mL 2 lidocaine with 1800000 epinephrine After five minutes one group will receive supplemental buccal infiltration of 30 mgmL of Ketorolac Tromethamine and the control group will receive buccal infiltration of normal saline Endodontic access preparation will initiate after 15 minutes of initial IANB with two negative responses to the electric pulp test The pain level will be recorded immediately and at the 246 and 24 hours following the treatment using Heft- Parker Visual Analog Scale HP- VAS Data will be evaluated using Repeated measured test if possible and otherwise non-parametric tests such as rival Friedman and X2 test Participants including major eligibility criteria all patients age ranged 18-65 with symptomatic irreversible pulpitis HP VAS 54 and without pain on percussion on a mandibular molar tooth who need root canal treatment and are without systemic diseases nonsmoking non pregnant non breast feeding without any medicine consumption or analgesic and sedation
Intervention Ketorolac infiltration
Main outcome measures Pain level at immediately after the treatment 2 4 6 and 24 hours following the root canal treatment using HP VAS
Design Randomized double blind clinical trial
Setting and conduct Sixty adult volunteers with including criteria will be divided into two groups n30 based on random table All patients will receive standard inferior alveolar nerve block of 2 lidocaine with 1800000 epinephrine and supplemental buccal infiltration of 09 mL 2 lidocaine with 1800000 epinephrine After five minutes one group will receive supplemental buccal infiltration of 30 mgmL of Ketorolac Tromethamine and the control group will receive buccal infiltration of normal saline Endodontic access preparation will initiate after 15 minutes of initial IANB with two negative responses to the electric pulp test The pain level will be recorded immediately and at the 246 and 24 hours following the treatment using Heft- Parker Visual Analog Scale HP- VAS Data will be evaluated using Repeated measured test if possible and otherwise non-parametric tests such as rival Friedman and X2 test Participants including major eligibility criteria all patients age ranged 18-65 with symptomatic irreversible pulpitis HP VAS 54 and without pain on percussion on a mandibular molar tooth who need root canal treatment and are without systemic diseases nonsmoking non pregnant non breast feeding without any medicine consumption or analgesic and sedation
Intervention Ketorolac infiltration
Main outcome measures Pain level at immediately after the treatment 2 4 6 and 24 hours following the root canal treatment using HP VAS
Detailed Description:
Objective The aim of this study is to evaluate premedication with ketorolac infiltration on post endodontic pain in patients with symptomatic irreversible pulpitis
Design Randomized double blind clinical trial
Setting and conduct Sixty adult volunteers with including criteria will be divided into two groups n30 based on random table All patients will receive standard inferior alveolar nerve block of 2 lidocaine with 1800000 epinephrine and supplemental buccal infiltration of 09 mL 2 lidocaine with 1800000 epinephrine After five minutes one group will receive supplemental buccal infiltration of 30 mgmL of Ketorolac Tromethamine and the control group will receive buccal infiltration of normal saline Endodontic access preparation will initiate after 15 minutes of initial IANB with two negative responses to the electric pulp test Endodontic treatment of all the patients will be performed in a single visit using crown down method and with rotary instrumentation till master apical file size 3006 The pain level will be recorded immediately and at the 246 and 24 hours following the treatment using Heft- Parker Visual Analog Scale HP- VAS Data will be evaluated using Repeated measured test if possible and otherwise non-parametric tests such as rival Friedman and X2 test Participants including major eligibility criteria all patients age ranged 18-65 with symptomatic irreversible pulpitis HP VAS 54 and without pain on percussion on a mandibular molar tooth who need root canal treatment and are without systemic diseases nonsmoking non pregnant non breast feeding without any medicine consumption or analgesic and sedation
Intervention Ketorolac infiltration
Main outcome measures The pain level immediately and at the 2 4 6 and 24 hours following the treatment using HP- VAS
Design Randomized double blind clinical trial
Setting and conduct Sixty adult volunteers with including criteria will be divided into two groups n30 based on random table All patients will receive standard inferior alveolar nerve block of 2 lidocaine with 1800000 epinephrine and supplemental buccal infiltration of 09 mL 2 lidocaine with 1800000 epinephrine After five minutes one group will receive supplemental buccal infiltration of 30 mgmL of Ketorolac Tromethamine and the control group will receive buccal infiltration of normal saline Endodontic access preparation will initiate after 15 minutes of initial IANB with two negative responses to the electric pulp test Endodontic treatment of all the patients will be performed in a single visit using crown down method and with rotary instrumentation till master apical file size 3006 The pain level will be recorded immediately and at the 246 and 24 hours following the treatment using Heft- Parker Visual Analog Scale HP- VAS Data will be evaluated using Repeated measured test if possible and otherwise non-parametric tests such as rival Friedman and X2 test Participants including major eligibility criteria all patients age ranged 18-65 with symptomatic irreversible pulpitis HP VAS 54 and without pain on percussion on a mandibular molar tooth who need root canal treatment and are without systemic diseases nonsmoking non pregnant non breast feeding without any medicine consumption or analgesic and sedation
Intervention Ketorolac infiltration
Main outcome measures The pain level immediately and at the 2 4 6 and 24 hours following the treatment using HP- VAS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None