NCT06011005

Brief Summary

The goal of this single-blinded randomized controlled trial is to compare pain perception during buccal infiltration using indirect EC spray and topical anesthesia and BC 20% topical gel, among seven to 10-year-old school children who attended Pediatric Dentistry Department at Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE). The main question\[s\] it aims to answer are: • How effective is the indirect application of EC topical spray anesthesia on pain perception during intraoral buccal injection in children in comparsion to BC 20%? Researchers will compare efficacy of 20% Benzocaine (BC) gel and indirect application of Ethyl Chloride (EC) spray to see if reducing pain perception during local anesthesia infiltration.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

July 5, 2023

Last Update Submit

August 22, 2023

Conditions

Dental Caries in ChildrenAnesthesia, LocalInjection Site Discomfort

Outcome Measures

Primary Outcomes (1)

  • Heart rate

    Each participant's heart rate will be recorded immediately before and after the injection using an FDA-approved pulse oximeter.

    5-10 minutes

Secondary Outcomes (3)

  • Sound, Eye, Motor (SEM) Index

    5-10 minutes

  • Visual Analog Scale (VAS)

    5-10 minutes

  • Face Pain Scale

    5-10 minutes

Study Arms (2)

(Group A) Ethyl Chloride (EC)

EXPERIMENTAL

Topical application for 30 sec.

Other: Ethyl Chloride spray (group A)

(Group B) Benzocaine gel 20% (BC)

ACTIVE COMPARATOR

BC 20% Topical gel application for 30 sec and left for 1 minute.

Other: Benzocaine gel 20% (group B)

Interventions

Ethyl Chloride spray (group A)OTHER

Cold test spray

(Group A) Ethyl Chloride (EC)
Benzocaine gel 20% (group B)OTHER

Topical analgesia

(Group B) Benzocaine gel 20% (BC)

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children (ASA I) aged between 7 - 10 years old.
  • Needing any maxillary buccal infiltration (anterior, middle, posterior)
  • Had no prior history of local anesthesia.
  • Frankl behavior III or IV
  • Not taking any painkillers, or other drugs that would influence with their pain perception.

You may not qualify if:

  • History of a medically compromised condition and intellectual disability. § Any allergy to local anesthesia.
  • Active pathology at the site of injection.
  • Prior history of intra-oral injection.
  • Frankl behavior I or II.
  • Children/parents not willing to participate in the study. § Needle phobia.
  • Patients require treatment under conscious sedation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed Bin Rashid University Of Medicine and Health Sciences

Multiple Locations, United Arab Emirates

RECRUITING

Related Publications (20)

  • Dasarraju RK, Svsg N. Comparative efficacy of three topical anesthetics on 7-11-year-old children: a randomized clinical study. J Dent Anesth Pain Med. 2020 Feb;20(1):29-37. doi: 10.17245/jdapm.2020.20.1.29. Epub 2020 Feb 28.

    PMID: 32158957RESULT

  • Lakshmanan L, Ravindran V. Efficacy of Cryotherapy Application on the Pain Perception during Intraoral Injection: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2021 Sep-Oct;14(5):616-620. doi: 10.5005/jp-journals-10005-2032.

    PMID: 34934271RESULT

  • Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.

    PMID: 23295957RESULT

  • Kreider KA, Stratmann RG, Milano M, Agostini FG, Munsell M. Reducing children's injection pain: lidocaine patches versus topical benzocaine gel. Pediatr Dent. 2001 Jan-Feb;23(1):19-23.

    PMID: 11242725RESULT

  • Gill CJ, Orr DL 2nd. A double-blind crossover comparison of topical anesthetics. J Am Dent Assoc. 1979 Feb;98(2):213-4. doi: 10.14219/jada.archive.1979.0476.

    PMID: 370178RESULT

  • 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: 26379379RESULT

  • 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: 31842771RESULT

  • Hersh EV, Houpt MI, Cooper SA, Feldman RS, Wolff MS, Levin LM. Analgesic efficacy and safety of an intraoral lidocaine patch. J Am Dent Assoc. 1996 Nov;127(11):1626-34; quiz 1665-6. doi: 10.14219/jada.archive.1996.0098.

    PMID: 8952239RESULT

  • Amado A, Sood A, Taylor JS. Contact allergy to lidocaine: a report of sixteen cases. Dermatitis. 2007 Dec;18(4):215-20. doi: 10.2310/6620.2007.06059.

    PMID: 18021602RESULT

  • Silver K, Silver J. The place of James Arnott (1797-1883) in the development of local anaesthesia in dentistry. Br Dent J. 2016 Mar 11;220(5):249-52. doi: 10.1038/sj.bdj.2016.179.

    PMID: 26964600RESULT

  • 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: 26957683RESULT

  • Ernst E, Fialka V. Ice freezes pain? A review of the clinical effectiveness of analgesic cold therapy. J Pain Symptom Manage. 1994 Jan;9(1):56-9. doi: 10.1016/0885-3924(94)90150-3.

    PMID: 8169463RESULT

  • 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: 25526231RESULT

  • 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: 19119169RESULT

  • DiMarco AC, Wetmore AO. Clinical Comparison: Fast-Acting and Traditional Topical Dental Anesthetic. Anesth Prog. 2016 Summer;63(2):55-61. doi: 10.2344/0003-3006-63.2.55.

    PMID: 27269661RESULT

  • Ballesteros-Pena S, Fernandez-Aedo I, Vallejo-De la Hoz G; en representacion del Grupo de Trabajo DIASURE. [Ethyl chloride aerosol spray for local anesthesia before arterial puncture: randomized placebo-controlled trial]. Emergencias. 2017 Jun;29(3):161-166. Spanish.

    PMID: 28825235RESULT

  • French JO, Hooker ML, Vause RB, Robinson AL. Dental Anaesthesia in Children: A Comparison of Vinyl Ether and Ethyl Chloride. Br Med J. 1940 Mar 16;1(4132):432-5. doi: 10.1136/bmj.1.4132.432. No abstract available.

    PMID: 20783002RESULT

  • Hori A, Poureslami HR, Parirokh M, Mirzazadeh A, Abbott P. The ability of pulp sensibility tests to evaluate the pulp status in primary teeth. Int J Paediatr Dent. 2011 Nov;21(6):441-5. doi: 10.1111/j.1365-263X.2011.01147.x. Epub 2011 Jun 27.

    PMID: 21702853RESULT

  • Asfour MA, Millar BJ, Smith PB. An assessment of the reliability of pulp testing deciduous teeth. Int J Paediatr Dent. 1996 Sep;6(3):163-6. doi: 10.1111/j.1365-263x.1996.tb00235.x.

    PMID: 9115971RESULT

  • Russell SC, Doyle E. A risk-benefit assessment of topical percutaneous local anaesthetics in children. Drug Saf. 1997 Apr;16(4):279-87. doi: 10.2165/00002018-199716040-00005.

    PMID: 9113495RESULT

Study Officials

  • Nagah Abdelrahman

    Mohammed Bin Rashid University of Medicine and Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nagah Abdelrahman

CONTACT

971551225599Nagah.abdelrahman@residents.mbru.ac.ae

Anas Alsalami

CONTACT

971508998048anas.alsalami@mbru.ac.ae

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 5, 2023

First Posted

August 25, 2023

Study Start

September 1, 2023

Primary Completion

October 24, 2023

Study Completion

December 31, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

AE(1)