Use of tramadol in dental injections for numbness on teeth
- Conditions
- Pulpitis,
- Registration Number
- CTRI/2022/10/046240
- Lead Sponsor
- Jamia Millia Islamia
- Brief Summary
**Introduction**
Successful local anaesthesia is the basis ofendodontic management of symptomatic teeth. However, dental anestheticinjections have a limited success rate in the first attempt (1–3). The success rate further decreases with the presenceof preoperative pain (4). The inferior alveolar nerve block (IANB) isparticularly notorious for high anesthetic failure rates, especially in teethassociated with symptomatic pulpitis (5). To achieve painless treatment in patients with afailed primary IANB, supplementary anaesthesia has been advised. Supplementaryintraligamentary (or periodontal injections) and intraosseous injections haveshown promising results (6). Thesupplementary injections aim to deposit the local anaesthetic solution in thecancellous bone close to the root apex. An intraligamentary injection is a formof intraosseous injection since the local anaesthetic solution is forced viaperforations in the dental socket to the cancellous bone around the root (7).
Tramadol hydrochloride is a centrally acting opioid analgesic (8). It is known to beeffective in the treatment of moderate to severe types of pain (9,10). Several researchers have conducted both in vitroand in vivo studies to test the local anaesthetic (LA) effect of tramadol (10–14). A study has reported that tramadol alone or incombination with adrenaline can be used as a local anaesthetic for theextraction of the upper molar tooth under a subperiosteal infiltration (15).
**Review of literature**: It has been reported that the presence of avasoconstrictor significantly increases the duration and efficacy of the intraligamentaryinjection field field(16). Success rates of up to 92% have been reported withboth pressure type and conventional syringes (4). The intraligamentary injection was introduced byMalamed in 1982 as an alternative to the conventional inferior alveolar nerveblock (17). Since then it has been evaluated both as a primaryinjection and as a supplementary injection, Kaufman et al compared the anaestheticefficacy of plain 2% lidocaine with 2% lidocaine with 1:50,000 epinephrine (18). The authors reported that the duration of anaesthesia with plainlidocaine was 1.02 min, while lidocaine with epinephrine had pulpal anaesthesiaof 27.05 min. Johnson et al compared the duration of anaesthesia of 1.5% etidocaine with 1:200,000 epinephrine and 2%lidocaine with 1:100,000 epinephrine given as an intraligamental injection (19). Etetidocaine gave 35% whereas lidocaine gave 55% success rates. Theauthors suggested that the anaesthetic efficacy in intraligamentary injectionswas more related to the concentration of epinephrine than the type of anaestheticagent. Meechan (2002) evaluated the anaesthetic efficacy of 2 differentconcentrations of plain ropivacaine vs. lidocaine containing epinephrine when given as a primary intraligamentary injection and reported that lignocaine with epinephrine was moreeffective than ropivacaine (20). A study evaluated the efficacy of local anaesthesia using tramadol hydrochloride(HCl) with versus without adrenaline in the extraction of upper molar teeth (15). The authors suggested that suggest tramadol HClin combination with adrenaline can be used as an alternative local anaesthetic.The majority of the studiesevaluating intraligamentary injections have been performed on asymptomaticteeth. Very limited research has been dedicated to the evaluation of differentvariables in intraligamentary injections in patients with symptomaticirreversible pulpitis.
**Aim :**
1. Tocompare the anaesthetic efficacy/ success rate of 2% lidocaine with 1: 80 000epinephrine vs. 2% lidocaine with 1:80 000 epinephrine plus tramadolhydrochloride (50 mg, 1:1 v/v ratio) given as a supplemental intraligamentaryinjection after a failed primary inferior alveolar nerve block.
**Objective** :
1. To achievepainless treatment in patients with a failed primary IANB. during theendodontic management of symptomatic mandibular first/second molar.
2..To evaluatethe heart rate during and after intraligamentary injections.
*Thenull hypothesis will be that different anaesthetic solutions have no effect onthe anaesthetic success rate or the heart rate.*
**Materials and Methods :**
Methodology: Prospective, randomized, double-blind clinical trial
Site: Conservative Dentistry, Faculty Of Dentistry, Jamia Millia Islamia
N: 30 patients in each group, total 60patients
Patientsexperiencing a failed primary IANB shall be enrolled on the study. The initialfailure will be defined as pain (score more than 54 on Heft Parker Visual Analog Scale (VAS) during access cavitypreparation or at root canal instrumentation stage (21). The primary outcome (endpoint) willbe defined as “success or failure†which will be indicated as the ability to undertakepulp access and canal instrumentation with no or mild pain. The secondary outcome will be the evaluation of heartrate after supplementary intraligamentary injections.
A tentative **samplesize calculation** has beenperformed using data from a previous study, keeping the αlevel type I error at0.05 for a single-tailedtest and β level type II errorat 0.20.19 The analysis indicated that a samplesize of 30subjects would give 80% power to detect a 25% difference in the success rates of the two different supplemental intraligamentaryinjections. For heart rate analysis, it has been calculated that a minimum of23 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).
Thetreatment procedure and the use of pain scales will be explained to thepatients. A combined VAS, the Heft-Parker scale (HP VAS), will be used in thepresent study (21).
I**nclusion criteria**:
1. Symptomatic carious exposed mandibular first or second molars.
2. Positive and prolonged response to thermal sensitivity tests and electric pulp test.
3. Vital coronal pulp on access cavity preparation.
4. American Society of Anesthesiologists class I or II medical history.
5. Ability to understand the use of pain scales.
**Exclusion criteria**
a. Active pain in more than 1 tooth.
b. Teeth with fused roots.
c. Radiographic evidence of an extra root.
d. Large restorations with overhanging margins.
e. Full crowns or deep periodontal pockets.
f. Known allergy or contraindications toany content of the localanaesthetic solution.
g. History of known or suspected drugabuse.
h. Taking any drugs which could affect thepain perception, e.g, opioids, antidepressants, anticonvulsants, musclerelaxants, anxiolytics, sedatives, NSAIDs. 23
i. Pregnant or breastfeeding patients.
All patients will receive a primary IANB injection using1.8 mL of 2% lidocaine with 1:80 000 epinephrine using a directHalsted approach. The needle will beinserted until bony resistance will be felt. After reachingthe target area, aspiration will be performed, and the solution will bedeposited over a period of 60seconds. After 10 minutes, the patients will be asked aboutlip numbness. Patients without profound lip numbness will be excluded from thestudy since the block will be considered ‘missed’. A conventionalaccess opening will be initiated after isolation with a rubber dam. Patientswill be instructed to raise their hands if any pain will be felt during theprocedure. In case of pain during treatment, the procedure will be stopped, andthe patientswill be asked to rate the pain on the HP VAS. The patients with failed primary IANB will receivesupplementary intraligamentary injections of 2% lidocaine with either 1:80 000or 2% lidocaine with 1:80 000 epinephrine plus tramadol hydrochloride (50 mg,1:1 v/v ratio). The cartridges will be masked with an opaque tape and will becoded with an alpha-numeric code. The code will be broken only after thecompletion of the study. The patients will be randomlyallocated to twotreatment groups (n=60, 30patients per group) with the help of an online randomgenerator. The rubber damwill be removed and the site of the injection will be cleaned with anantiseptic solution. The resting heart rate will be monitored with a fingerpulse oximeter by a faculty member. The first group will receiveintraligamentary injections of 2% lidocaine with 1: 80 000 epinephrine. Theinjections will be administered using a pressure-type syringe (Osung Deosy, Pearland, Tx, USA) and 30 gauge short needles (Septojet needles, Septodont). The secondgroup will receive intraligamentaryinjections of 2% lidocaine with 1:80 000 epinephrine plus tramadol hydrochloride(50 mg, 1:1 v/v ratio). In both groups, atotal of 1.2 mL of anaesthetic solution will be deposited. The heart rate willbe measured at 15-second intervals till 5 minutes after intraligamentaryinjections. Success will be again defined as no pain or faint/weak/mild pain during endodonticaccess preparation and instrumentation.
**Statisticalanalysis**: The resultswill be tabulated in contingency tables. The age of patients will be analyzedusing the Mann-Whitney U test at P < .05. The gender and distribution of teeth will be analyzedusing 2X2 contingency tables and chi-square tests. The anaesthetic successrates will be analyzed with the Pearson chi-square test. The heart rate changeswill be analyzed using a t-test.
**Sourceof funding**: None
**Conflictsof interest**: None
**Workschedule**: the study isexpected to be completed in 2 months
**Technicalsupport required**: None
**References**
1. HargreavesKM, Keiser K. Local anesthetic failure in endodontics:. Mechanisms andManagement. Endod Top. 2002 Mar;1(1):26–39.
2. BerlinJ, Nusstein J, Reader A, Beck M, Weaver J. Efficacy of articaine and lidocainein a primary intraligamentary injection administered with a computer-controlledlocal anesthetic delivery system. Oral Surg Oral Med Oral Pathol Oral RadiolEndod. 2005 Mar;99(3):361–6.
3. BigbyJ, Reader A, Nusstein J, Beck M, Weaver J. Articaine for supplementalintraosseous anesthesia in patients with irreversible pulpitis. J Endod. 2006 Nov;32(11):1044–7.
4. ClaffeyE, Reader A, Nusstein J, Beck M, Weaver J. Anesthetic Efficacy of Articain for InferiorAlveolar Nerve Blocks in Patients with Irreversible Pulpitis. J Endod. 2004Aug;30(8):568–71.
5. Claffey E, Reader A, Nusstein J, Beck M, WeaverJ. Anesthetic efficacy of articaine for inferior alveolar nerve blocks inpatients with irreversible pulpitis. J Endod. 2004 Aug;30(8):568-71.
6. AtbaeiA, Mortazavi N. Prophylactic intraligamentary injection of piroxicam (feldene)for the management of post-endodontic pain in molar teeth with irreversiblepulpitis. Aust Endod J. 2012 Apr;38(1):31–5.
7. BeckerDE, Reed KL. Local Anesthetics: Review of Pharmacological Considerations.Anesth Prog. 2012;59(2):90–102.
8. ManeRJ, Choi JJE, Sharpe-Davidson WF. Tramadol as a local anaesthetic agent indentistry: A systematic review of local and systemic adverse effects. SaudiDent J. 2021 Dec;33(8):842–52.
9. AksoyF, Ege B. The effect of pretreatment submucosal injections of tramadol anddexamethasone on post-endodontic pain in mandibular molar teeth withsymptomatic irreversible pulpitis: a randomized controlled clinical trial. IntEndod J. 2020 Feb;53(2):176–85.
10. CollinsM, Young I, Sweeney P, Fenn GC, Stratford ME, Wilson A, et al. The effect oftramadol on dento-alveolar surgical pain. Br J Oral Maxillofac Surg. 1997Feb;35(1):54–8.
11. AhmadQureshi A, Mousa Bakri M. Comparative study of local anesthetic efficacy of 5%tramadol versus 2 %Lignocaine with 1:100,000 adrenaline for extraction offully erupted maxillary 3rd molars using infiltration anesthesia. Saudi Dent J.2022 May;34(4):306–9.
12. Ege B,Calisir M, Al-Haideri Y, Ege M, Gungormus M. Comparison of Local AnestheticEfficiency of Tramadol Hydrochloride and Lidocaine Hydrochloride. J Am AssocOral Maxillofac Surg. 2018 Apr;76(4):744–51.
13. OngCKS, Lirk P, Tan JMH, Sow BWY. The analgesic efficacy of intravenous versusoral tramadol for preventing postoperative pain after third molar surgery. J AmAssoc Oral Maxillofac Surg. 2005 Aug;63(8):1162–8.
14. ShiptonEA, Roelofse JA, Blignaut RJ. An evaluation of analgesic efficacy and clinicalacceptability of intravenous tramadol as an adjunct to propofol sedation forthird molar surgery. Anesth Prog. 2003;50(3):121–8.
15. Al-HaideriYAA. Comparison of local anesthetic efficacy of tramadol hydrochloride (withadrenaline) versus plain tramadol hydrochloride in the extraction of uppermolar teeth. J Am Assoc Oral Maxillofac Surg. 2013 Dec;71(12):2035–8.
16. AggarwalV, Singla M, Miglani S, Kohli S. Comparison of the anaesthetic efficacy ofepinephrine concentrations (1 : 80 000 and1 : 200 000) in 2% lidocaine for inferior alveolar nerve blockin patients with symptomatic irreversible pulpitis: A randomized, double-blindclinical trial. Int Endod J. 2014;47(4).
17. MalamedSF. The periodontal ligament (PDL) injection: An alternative to inferioralveolar nerve block. Oral Surg Oral Med Oral Pathol. 1982 Feb;53(2):117–21.
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 100
- Inclusion criteria: a.Symptomatic carious exposed mandibular first or second molars.
- b.Positive and prolonged response to thermal sensitivity tests and electric pulp test.
- c.Vital coronal pulp on access cavity preparation.
- d.American Society of Anesthesiologists class I or II medical history.
- e.Ability to understand the use of pain scales.
- Exclusion criteria a.Active pain in more than 1 tooth.
- b.Teeth with fused roots.
- c.Radiographic evidence of an extra root.
- d.Large restorations with overhanging margins.
- e.Full crowns or deep periodontal pockets.
- f.Known allergy or contraindications to any content of the local anaesthetic solution.
- g.History of known or suspected drug abuse.
- h.Taking any drugs which could affect the pain perception, e.g, opioids, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, NSAIDs. i.Pregnant or breastfeeding patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anesthetic success during endodontic procedures 10 Minutes after inytaligamentary injections
- Secondary Outcome Measures
Name Time Method Measurements of heart rates 5 minutes after injections
Trial Locations
- Locations (1)
Faculty of Dentistry
🇮🇳South, DELHI, India
Faculty of Dentistry🇮🇳South, DELHI, IndiaVivekl AggarwalPrincipal investigator01126982006drvivekaggarwal@gmail.com