EFFECTIVENESS OF A DEVICE PLACED ON THE SIDE OF THE FACE IN REDUCING DISCOMFORT DURING AN INJECTION GIVEN INSIDE THE MOUTH OF CHILDREN

EFFICACY OF AN EXTERNAL COLD AND VIBRATING DEVICE IN REDUCING DISCOMFORT DURING THE ADMINISTRATION OF AN INFERIOR ALVEOLAR NERVE BLOCK IN CHILDREN : A SPLIT MOUTH RANDOMISED CROSSOVER STUDY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026702

Enrollment

Registered

2020-07-20

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: EXTERNAL COLD AND VIBRATING DEVICE (BUZZYÃ?Â®, MMJ LABS, ATLANTA GA, USA): THE CHILDREN ASSIGNED TO THE STUDY GROUP WILL BE ADMINISTERED THE INFERIOR ALVEOLAR NERVE BLOCK COUPLED WITH T

Eligibility

Inclusion criteria

Inclusion criteria: 1.CHILDREN BETWEEN 6 AND 10 YEARS OF AGE WITH NO PRIOR EXPERIENCE OF AN INTRAORAL LOCAL ANAESTHETIC INJECTION. 2.CHILDREN WITH ANY MANDIBULAR TOOTH/TEETH INDICATED FOR BILATERAL DENTAL PROCEDURES THAT WARRANTS THE USE OF AN INFERIOR ALVEOLAR NERVE BLOCK. 3.CHILDREN CLASSIFIED AS Ã¢â?¬Å?POTENTIALLY COOPERATIVEÃ¢â?¬? ACCORDING TO THE WRIGHT BEHAVIOUR CLASSIFICATION (WRIGHT 1975) OR CHILDREN WITH THEIR BEHAVIOUR RATED AS (+) ON THE FRANKL BEHAVIOUR RATING SCALE. 4.CHILDREN CLASSIFIED AS ASA I ACCORDING TO THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS PHYSICAL STATUS CLASSIFICATION SYSTEM (ASA- PS).

Exclusion criteria

Exclusion criteria: 1.CHILDREN WITH A HISTORY OF RECENT HOSPITALISATION OR SURGERY. 2.CHILDREN WHO HAVE TAKEN ANY CENTRAL NERVOUS SYSTEM DEPRESSANTS OR ANY ANALGESIC MEDICATIONS WITHIN EIGHT HOURS PRIOR TO THE TREATMENT. 3.CHILDREN WITH EXISTING OROFACIAL EDEMA, INFECTION, OR ABSCESS, SYSTEMIC COMORBIDITIES REQUIRING SPECIAL DENTAL TREATMENT CONSIDERATIONS.

Design outcomes

Primary

Measure	Time frame
TO EVALUATE THE DISCOMFORT EXPERIENCED BY CHILDREN DURING THE ADMINISTRATION OF AN INFERIOR ALVEOLAR NERVE BLOCK WITH THE APPLICATION OF AN EXTERNAL COLD AND VIBRATING DEVICE BY USING WONG-BAKER FACES PAIN RATING SCALE (WBFPRS).Timepoint: AT THE TIME OF INTERVENTION	—

Secondary

Measure	Time frame
TO EVALUATE THE DISCOMFORT EXPERIENCED BY CHILDREN DURING THE ADMINISTRATION OF AN INFERIOR ALVEOLAR NERVE BLOCK WITH THE APPLICATION OF AN EXTERNAL COLD AND VIBRATING DEVICE BY USING THE FACE, LEGS, ACTIVITY, CRY, CONSOLABILITY SCALE (FLACC SCALE). Timepoint: AT THE TIME OF INTERVENTION	—

Countries

India

Contacts

Public ContactDr ANANTHU H

MANIPAL COLLEGE OF DENTAL SCIENCES, MANGALORE

ashwin.rao@manipal.edu9945510215

Outcome results