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Clinical Trials/CTRI/2018/04/013424
CTRI/2018/04/013424Not yet recruitingNot Applicable

Comparison of pain perception in child patients during IANB using local anaesthetic solution at room temperature and 42°C.

Government1 site in 1 country60 target enrollmentStarted: April 25, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Patient May Feel Less Pain During Local Anesthesia administration At 42°C

Study Overview

Brief Summary

Local anaesthetic cause pain during administration into soft tissue and this leads to stress and discomfort especially in child patients. This pain can be reduced easily and effectively by heating the local anaesthetic solution up to body temperature or above.Warming lidocaine causes no chemical denaturation or no diminished stability stated by one lidocaine manufacturer (Elkins-Sinn, Inc, Cherry Hill, NJ). This method reduces burning sensation in orthography, angiography and other interventional procedures by warming lidocaine to 43°C before infiltrative injection. We are planning to use this method to reduce discomfort during nerve block in pediatric dental patients.

This study will  include 60 child patients of age 6-10 years in which pain perception will be  evaluated during Inferior alveolar nerve block using warm local anaesthetic at 42°C. During first visit  the children will receive IANB block consisting of  lidocaine 2% and epinephrine 1:2,00,000 at room temperature. At the second visit, the contralateral side will receive local anaesthetic warmed at 42°C.  15 cm long visual analogue scale will be used to determine the pain from injection given.

We are hopeful that this method will work on pediatric dental setting also.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
6.00 Year(s) to 10.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Healthy child patients requiring routine dental treatment especially without known history of hypersensitivity to local anaesthetic lidocaine.
  • •patients that need bilateral pulpotomy or extraction of teeth in mandibular molars requiring local anaesthetics (LA) with 2% lidocaine with 1: 2,00,000 epinephrine.

Exclusion Criteria

  • •patients having systemic ailment.
  • •Patients having known allergy to Local anesthetic lidocain.
  • •patients who does not require local anesthetic for treatment.

Outcomes

Primary Outcomes

Patient May Feel Less Pain During Local Anesthesia administration At 42°C

Time Frame: 2 minutes

Secondary Outcomes

  • Injection fear may reduce in child patients(5 minutes)

Investigators

Sponsor
Government
Sponsor Class
Other [Government Dental College ]

Study Sites (1)

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