Pre Injection Use of Cryoanesthesia Versus Topical Anesthetic Gel in Reducing Pain Perception During Palatal Injections

NCT06165432 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 556/077/078
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to assess the effectiveness of pre-injection use of topical ice application in decreasing pain perception when administering greater palatine nerve block injections as compared to that of topical 20 % benzocaine anesthetic gel using Visual Analogue Scale (VAS) for subjective pain assessment and Sound, Eye, Motor (SEM) scale for objective pain assessment in adult patients. The main question it aims to answer are:

1. 1.Does topical cooling reduce pain as effectively as topical benzocaine during greater palatine nerve block injections?
2. 2.Is there any adverse reactions during and after application of topical ice and 20 % benzocaine gel?
3. 3.Is there any difference in patient acceptability to the use of either methods during the administration of greater palatine nerve block.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• subjective pain perception during greater palatine nerve block injection

  measured using Visual analogue Scale (VAS) - The Visual Analogue Scale (VAS) consisting of a 100 mm straight line with the endpoints marked to denote extreme limits on the left as 'no pain at all' and on the right as 'pain as bad as it could be' was used to record the pain score . The patient was asked to mark their pain level on the line between the two endpoints after receiving the palatal injection. The distance between 'no pain at all' and the mark defined the subject's pain which was measured in millimeters.

  Immediatley after the injection

• objective pain perception during greater palatine nerve block injection

  measured using Sound, Eye and Motor (SEM) scale -The SEM scale was used in the assessment of the relationship between pain and the reactions which the sensation of pain generates in the patient's eyes, bodily movements and verbal expressions of discomfort

  During the injection procedure

Secondary Outcomes (2)

• Adverse effects

  upto 30 minutes after the injection

• Acceptability regarding the use of either topical ice or topical benzocaine

  5 minutes after application

Study Arms (2)

Drug Arm :Topical benzocaine

ACTIVE COMPARATOR

since its a split mouth study one half of the hard palate will receive topical benzocaine i.e Group A

Drug: Topical Benzocaine

Topical ice

ACTIVE COMPARATOR

Other half of the palate will receive topical ice i.e Group B

Other: Topical ice

Interventions

Topical Benzocaine DRUG

Benzocaine topical anesthetic gel will be used a pre-injection anesthetic on one half of the palate before giving greater palatine nerve block

Drug Arm :Topical benzocaine

Topical ice OTHER

For the other half of the palate topical ice would be used before greater palatine nerve block

Topical ice

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinically healthy patients ASA I and ASA II with intact palatal mucosa on both sides
• Procedures that needs administration of greater palatine nerve block

You may not qualify if:

• Hypersensitivity to local anesthetic agent
• Patient who are physically and mentally sub normal
• Presence of palatal mucosal lesions
• Patients on long term neuromodulators for chronic pain
• Patient not consenting to participate in the study

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

B.P Koirala institute of health sciences

Dharān, Koshi, 56700, Nepal

Location

Related Publications (32)

• Hindocha N, Manhem F, Backryd E, Bagesund M. Ice versus lidocaine 5% gel for topical anaesthesia of oral mucosa - a randomized cross-over study. BMC Anesthesiol. 2019 Dec 16;19(1):227. doi: 10.1186/s12871-019-0902-8.

  PMID: 31842771 BACKGROUND

• Davoudi A, Rismanchian M, Akhavan A, Nosouhian S, Bajoghli F, Haghighat A, Arbabzadeh F, Samimi P, Fiez A, Shadmehr E, Tabari K, Jahadi S. A brief review on the efficacy of different possible and nonpharmacological techniques in eliminating discomfort of local anesthesia injection during dental procedures. Anesth Essays Res. 2016 Jan-Apr;10(1):13-6. doi: 10.4103/0259-1162.167846.

  PMID: 26957683 BACKGROUND

• Kumar M, Chawla R, Goyal M. Topical anesthesia. J Anaesthesiol Clin Pharmacol. 2015 Oct-Dec;31(4):450-6. doi: 10.4103/0970-9185.169049.

  PMID: 26702198 BACKGROUND

• Meechan JG. Intra-oral topical anaesthetics: a review. J Dent. 2000 Jan;28(1):3-14. doi: 10.1016/s0300-5712(99)00041-x.

  PMID: 10666956 BACKGROUND

• Gondim DGA, Montagner AM, Pita-Neto IC, Bringel RJS, Sandrini FAL, Moreno EFC, de Sousa AM, Correia AB. Comparative Analysis of the Effectiveness of the Topical Administration of Benzocaine and EMLA(R) on Oral Pain and Tactile Sensitivity. Int J Dent. 2018 Feb 7;2018:7916274. doi: 10.1155/2018/7916274. eCollection 2018.

  PMID: 29593794 BACKGROUND

• Lee HS. Recent advances in topical anesthesia. J Dent Anesth Pain Med. 2016 Dec;16(4):237-244. doi: 10.17245/jdapm.2016.16.4.237. Epub 2016 Dec 31.

  PMID: 28879311 BACKGROUND

• Kosaraju A, Vandewalle KS. A comparison of a refrigerant and a topical anesthetic gel as preinjection anesthetics: a clinical evaluation. J Am Dent Assoc. 2009 Jan;140(1):68-72; quiz 112-3. doi: 10.14219/jada.archive.2009.0020.

  PMID: 19119169 BACKGROUND

• Fuzier R, Lapeyre-Mestre M, Mertes PM, Nicolas JF, Benoit Y, Didier A, Albert N, Montastruc JL; French Association of Regional Pharmacovigilance Centers. Immediate- and delayed-type allergic reactions to amide local anesthetics: clinical features and skin testing. Pharmacoepidemiol Drug Saf. 2009 Jul;18(7):595-601. doi: 10.1002/pds.1758.

  PMID: 19402039 BACKGROUND

• Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11.

  PMID: 26379379 BACKGROUND

• Jayasuriya NSS, Weerapperuma ID, Amarasinghe MGCK. The use of an iced cotton bud as an effective pre-cooling method for palatal anaesthesia: A technical note. Singapore Dent J. 2017 Dec;38:17-19. doi: 10.1016/j.sdj.2017.07.001.

  PMID: 29229069 BACKGROUND

• Bose S, Garg N, Pathivada L, Yeluri R. Cooling the soft tissue and its effect on perception of pain during infiltration and block anesthesia in children undergoing dental procedures: A comparative study. J Dent Res Dent Clin Dent Prospects. 2019 Summer;13(3):159-165. doi: 10.15171/joddd.2019.025. Epub 2019 Oct 7.

  PMID: 31857860 BACKGROUND

• Tirupathi SP, Rajasekhar S. Effect of precooling on pain during local anesthesia administration in children: a systematic review. J Dent Anesth Pain Med. 2020 Jun;20(3):119-127. doi: 10.17245/jdapm.2020.20.3.119. Epub 2020 Jun 24.

  PMID: 32617406 BACKGROUND

• Malanga GA, Yan N, Stark J. Mechanisms and efficacy of heat and cold therapies for musculoskeletal injury. Postgrad Med. 2015 Jan;127(1):57-65. doi: 10.1080/00325481.2015.992719. Epub 2014 Dec 15.

  PMID: 25526231 BACKGROUND

• van Wijk AJ, Hoogstraten J. Anxiety and pain during dental injections. J Dent. 2009 Sep;37(9):700-4. doi: 10.1016/j.jdent.2009.05.023. Epub 2009 May 27.

  PMID: 19556053 BACKGROUND

• Harbert H. Topical ice: a precursor to palatal injections. J Endod. 1989 Jan;15(1):27-8. doi: 10.1016/S0099-2399(89)80094-9.

  PMID: 2607263 BACKGROUND

• Covino BG. Pharmacology of local anaesthetic agents. Br J Anaesth. 1986 Jul;58(7):701-16. doi: 10.1093/bja/58.7.701.

  PMID: 2425835 BACKGROUND

• de Freiras GC, Pozzobon RT, Blaya DS, Moreira CH. Efficacy of Benzocaine 20% Topical Anesthetic Compared to Placebo Prior to Administration of Local Anesthesia in the Oral Cavity: A Randomized Controlled Trial. Anesth Prog. 2015 Summer;62(2):46-50. doi: 10.2344/0003-3006-62.2.46.

  PMID: 26061572 BACKGROUND

• Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

  PMID: 11733293 BACKGROUND

• Sirintawat N, Sawang K, Chaiyasamut T, Wongsirichat N. Pain measurement in oral and maxillofacial surgery. J Dent Anesth Pain Med. 2017 Dec;17(4):253-263. doi: 10.17245/jdapm.2017.17.4.253. Epub 2017 Dec 28.

  PMID: 29349347 BACKGROUND

• Hameed NN, Sargod SS, Bhat SS, Hegde SK, Bava MM. Effectiveness of precooling the injection site using tetrafluorethane on pain perception in children. J Indian Soc Pedod Prev Dent. 2018 Jul-Sep;36(3):296-300. doi: 10.4103/JISPPD.JISPPD_222_17.

  PMID: 30246753 BACKGROUND

• Agrawal S, Sharma A, Dhurat R, Chahal K. The use of surgical gloves as an aseptic, effective, and inexpensive method to deliver circumferential cryoanesthesia. J Am Acad Dermatol. 2020 Jun;82(6):e195-e196. doi: 10.1016/j.jaad.2019.03.033. Epub 2019 Mar 21. No abstract available.

  PMID: 30905796 BACKGROUND

• Ghaderi F, Banakar S, Rostami S. Effect of pre-cooling injection site on pain perception in pediatric dentistry: "A randomized clinical trial". Dent Res J (Isfahan). 2013 Nov;10(6):790-4.

  PMID: 24379869 BACKGROUND

• Vafaei A, Rahbar M, Dadkhah R, Ranjkesh B, Erfanparast L. Children's Pain Perception and Behavioral Feedback during Local Anesthetic Injection with Four Injection Site Preparation Methods. Maedica (Bucur). 2019 Dec;14(4):343-349. doi: 10.26574/maedica.2019.14.4.343.

  PMID: 32153664 BACKGROUND

• Pancekauskaite G, Jankauskaite L. Paediatric Pain Medicine: Pain Differences, Recognition and Coping Acute Procedural Pain in Paediatric Emergency Room. Medicina (Kaunas). 2018 Nov 27;54(6):94. doi: 10.3390/medicina54060094.

  PMID: 30486427 BACKGROUND

• Flanagan T, Wahl MJ, Schmitt MM, Wahl JA. Size doesn't matter: needle gauge and injection pain. Gen Dent. 2007 May-Jun;55(3):216-7.

  PMID: 17511363 BACKGROUND

• Dao TT, LeResche L. Gender differences in pain. J Orofac Pain. 2000 Summer;14(3):169-84; discussion 184-95.

  PMID: 11203754 BACKGROUND

• Bagesund M, Tabrizi P. Lidocaine 20% patch vs lidocaine 5% gel for topical anaesthesia of oral mucosa. Int J Paediatr Dent. 2008 Nov;18(6):452-60. doi: 10.1111/j.1365-263X.2007.00910.x. Epub 2008 Mar 12.

  PMID: 18341564 BACKGROUND

• Udeh C, Bittikofer J, Sum-Ping ST. Severe methemoglobinemia on reexposure to benzocaine. J Clin Anesth. 2001 Mar;13(2):128-30. doi: 10.1016/s0952-8180(01)00222-7.

  PMID: 11331174 BACKGROUND

• Gonzalez-Rodriguez AJ, Gutierrez-Paredes EM, Revert Fernandez A, Jorda-Cuevas E. Allergic contact dermatitis to benzocaine: the importance of concomitant positive patch test results. Actas Dermosifiliogr. 2013 Mar;104(2):156-8. doi: 10.1016/j.ad.2011.07.023. Epub 2012 Apr 30. English, Spanish.

  PMID: 22551703 BACKGROUND

• AmruthaVarshini I, Vinay C, Uloopi KS, RojaRamya KS, Chandrasekhar R, Penmatsa C. Effectiveness of Pre-cooling the Injection Site, Laser Biostimulation, and Topical Local Anesthetic Gel in Reduction of Local Anesthesia Injection Pain in Children. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):81-83. doi: 10.5005/jp-journals-10005-1913.

  PMID: 34326589 RESULT

• Wiswall AT, Bowles WR, Lunos S, McClanahan SB, Harris S. Palatal anesthesia: comparison of four techniques for decreasing injection discomfort. Northwest Dent. 2014 Jul-Aug;93(4):25-9.

  PMID: 25233569 RESULT

• Anantharaj A, Sabu JM, Ramakrishna S, Jagdeesh RB, Praveen P, Shankarappa PR. A comparative evaluation of pain perception following topical application of benzocaine gel, clove-papaya based anesthetic gel and precooling of the injection site before intraoral injections in children. J Indian Soc Pedod Prev Dent. 2020 Apr-Jun;38(2):184-189. doi: 10.4103/JISPPD.JISPPD_153_18.

  PMID: 32611866 RESULT

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MeSH Terms

Conditions

Pain

Interventions

Benzocaine; Ice

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Officials

• Mehul Jaisani, MDS

  B.P. Koirala Insititute of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessment of objective pain using Sound, Eye and Motor scale will be done by a single outcome assessor who will be blinded about the intervention technique.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Cross sectional comparative split mouth study

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: December 11, 2023
• Study Start: March 19, 2021
• Primary Completion: September 20, 2021
• Study Completion: January 5, 2022
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 3 months after publication
• Access Criteria: via email

Locations

NE (1)