Ignite Creation Date:
2024-05-06 @ 6:05 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05538052
Status:
COMPLETED
Last Update Posted:
2022-12-19
First Post:
2022-09-08
Brief Title:
Use of Tramadol Intraligamentary Injections
Sponsor:
Jamia Millia Islamia
Organization:
Jamia Millia Islamia
Study Overview
Official Title:
Use of Tramadol Injections on the Anaesthetic Success Rate of Intraligamentary Injections in Patients With Symptomatic Irreversible Pulpitis
Status:
COMPLETED
Status Verified Date:
2022-12
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:
Introduction To achieve painless treatment in patients with a failed primary IANB supplementary anaesthesia has been advised The majority of the studies evaluating intraligamentary injections have been performed on asymptomatic teeth Very limited research has been dedicated to the evaluation of different variables in intraligamentary injections in patients with symptomatic irreversible pulpitis Aim To evaluate the anaesthetic efficacy of 2 lidocaine with 180 000 epinephrine vs 2 lidocaine with 180 000 epinephrine plus tramadol hydrochloride 50 mg 11 vv ratio given as intraligamentary injections after a failed inferior alveolar nerve block IANB in patients with symptomatic irreversible pulpitis Objective 1 To achieve painless treatment in patients with a failed primary IANB during the endodontic management of symptomatic mandibular firstsecond molar 2 To evaluate the heart rate during and after intraligamentary injections Methods This prospective randomized double-blind clinical trial will be carried out by Conservative Dentistry Faculty Of Dentistry Jamia Millia Islamia Sixty adult patients with symptomatic irreversible pulpits in a mandibular first or second molar will receive an initial IANB with 2 lidocaine with 180 000 epinephrine Pain during the endodontic treatment will be assessed using a visual analogue scaleVAS Patients experiencing pain on endodontic intervention shall be randomly allocated to one of the two treatment groups one group shall receive 06 mL root of supplementary intraligamentary injection of 2 lidocaine with 180 000 epinephrine while the second group shall receive 2 lidocaine with 180 000 epinephrine plus tramadol hydrochloride 50 mg 11 vv ratio Endodontic treatment will be re-initiated Success after primary injection or supplementary injection will be defined as no or mild pain less than 55 mm on HP VAS during access preparation and root canal instrumentation Heart rate will be monitored using a finger pulse oximeter by a faculty member Statistical analysis The results will be tabulated in contingency tables The anaesthetic success rates will be analyzed with the Pearson chi-square test at 5 significance levels The heart rate changes will be analyzed using a t-test
Detailed Description:
Patients experiencing a failed primary IANB shall be enrolled in the study The initial failure will be defined as pain score more than 54 on Heft Parker Visual Analog Scale VAS during access cavity preparation or at the root canal instrumentation stage The primary outcome endpoint will be defined as success or failure indicating the ability to undertake pulp access and canal instrumentation with no or mild pain The secondary outcome will be the evaluation of heart rate after supplementary intraligamentary injections
A tentative sample size calculation has been performed using data from a previous study keeping the α level type I error at 005 for a single-tailed test and β level type II error at 02019 The analysis indicated that a sample size of 35 subjects would give 80 power to detect a 30 difference in the success rates of the two different supplemental intraligamentary injections For heart rate analysis it has been calculated that a minimum of 23 patients per group shall be required to detect a difference of 10 beats per minute with a baseline heart rate of 72 beats per minute
The treatment procedure and the use of pain scales will be explained to the patients A combined VAS the Heft-Parker scale HP VAS will be used in the present study
All patients will receive a primary IANB injection using 18 mL of 2 lidocaine with 1 80 000 epinephrine using a direct Halsted approach The needle will be inserted until bony resistance will be felt After reaching the target area aspiration will be performed and the solution will be deposited over a period of 60 seconds After 10 minutes the patients will be asked about lip numbness Patients without profound lip numbness will be excluded from the study since the block will be considered missed A conventional access opening will be initiated after isolation with a rubber dam Patients will be instructed to raise their hands if any pain will be felt during the procedure In case of pain during treatment the procedure will be stopped and the patients will be asked to rate the pain on the HP VAS The patients with failed primary IANB will receive supplementary intraligamentary injections of either 2 lidocaine with 180 000 epinephrine or 2 lidocaine with 180 000 epinephrine plus tramadol hydrochloride 50 mg 11 vv ratio or tramadol hydrochloride 25mgmL The cartridges will be masked with an opaque tape and coded with an alpha-numeric code The code will be broken only after the completion of the study The patients will be randomly allocated to three treatment groups n105 35 patients per group with the help of an online random generator The rubber dam will be removed and the injection site will be cleaned with an antiseptic solution The resting heart rate will be monitored with a finger pulse oximeter by a faculty member The first group will receive intraligamentary injections of 2 lidocaine with 1 80 000 epinephrine The injections will be administered using a pressure-type syringe Osung Deosy Pearland Tx USA and 30 gauge short needles Septojet needles Septodont The second group will receive intraligamentary injections of 2 lidocaine with 180 000 epinephrine plus tramadol hydrochloride 50 mg 11 vv ratio The third group shall receive intraligamentary injections of tramadol hydrochloride 25mg mL A total of 12 mL of anaesthetic solution will be deposited The heart rate will be measured at 15-second intervals till 5 minutes after intraligamentary injections Success will be again defined as no pain or faintweakmild pain during endodontic access preparation and instrumentation
Statistical analysis The results will be tabulated in contingency tables The age of patients will be analyzed using the Mann-Whitney U test at P 05 The gender and distribution of teeth will be analyzed using 2X2 contingency tables and chi-square tests The anaesthetic success rates will be analyzed with the Pearson chi-square test The heart rate changes will be analyzed using a t-test
A tentative sample size calculation has been performed using data from a previous study keeping the α level type I error at 005 for a single-tailed test and β level type II error at 02019 The analysis indicated that a sample size of 35 subjects would give 80 power to detect a 30 difference in the success rates of the two different supplemental intraligamentary injections For heart rate analysis it has been calculated that a minimum of 23 patients per group shall be required to detect a difference of 10 beats per minute with a baseline heart rate of 72 beats per minute
The treatment procedure and the use of pain scales will be explained to the patients A combined VAS the Heft-Parker scale HP VAS will be used in the present study
All patients will receive a primary IANB injection using 18 mL of 2 lidocaine with 1 80 000 epinephrine using a direct Halsted approach The needle will be inserted until bony resistance will be felt After reaching the target area aspiration will be performed and the solution will be deposited over a period of 60 seconds After 10 minutes the patients will be asked about lip numbness Patients without profound lip numbness will be excluded from the study since the block will be considered missed A conventional access opening will be initiated after isolation with a rubber dam Patients will be instructed to raise their hands if any pain will be felt during the procedure In case of pain during treatment the procedure will be stopped and the patients will be asked to rate the pain on the HP VAS The patients with failed primary IANB will receive supplementary intraligamentary injections of either 2 lidocaine with 180 000 epinephrine or 2 lidocaine with 180 000 epinephrine plus tramadol hydrochloride 50 mg 11 vv ratio or tramadol hydrochloride 25mgmL The cartridges will be masked with an opaque tape and coded with an alpha-numeric code The code will be broken only after the completion of the study The patients will be randomly allocated to three treatment groups n105 35 patients per group with the help of an online random generator The rubber dam will be removed and the injection site will be cleaned with an antiseptic solution The resting heart rate will be monitored with a finger pulse oximeter by a faculty member The first group will receive intraligamentary injections of 2 lidocaine with 1 80 000 epinephrine The injections will be administered using a pressure-type syringe Osung Deosy Pearland Tx USA and 30 gauge short needles Septojet needles Septodont The second group will receive intraligamentary injections of 2 lidocaine with 180 000 epinephrine plus tramadol hydrochloride 50 mg 11 vv ratio The third group shall receive intraligamentary injections of tramadol hydrochloride 25mg mL A total of 12 mL of anaesthetic solution will be deposited The heart rate will be measured at 15-second intervals till 5 minutes after intraligamentary injections Success will be again defined as no pain or faintweakmild pain during endodontic access preparation and instrumentation
Statistical analysis The results will be tabulated in contingency tables The age of patients will be analyzed using the Mann-Whitney U test at P 05 The gender and distribution of teeth will be analyzed using 2X2 contingency tables and chi-square tests The anaesthetic success rates will be analyzed with the Pearson chi-square test The heart rate changes will be analyzed using a t-test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None