Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-10-31

Brief Summary

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This study aims to assess Effectiveness of Pre-administered Natural Sweet-tasting Solution (honey) for Decreasing Pain Associated with Dental Injections (infiltration) prior to dental extraction in 6-8 years old healthy Children (first dental visit) In comparison to topical anesthesia.

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Detailed Description

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The administration of local anesthetics is one of the most dreaded or anxiety-inducing triggers in a dental setup. Patients, particularly children, may be fearful of dental injections, which may prevent them from seeking dental treatment. Even though profound local anesthesia aids in the treatment of pediatric patients in terms of reducing their anxiety and pain during restorative and surgical procedures, the fear of needles has been cited as a barrier to develop proper dental care. Numerous techniques have been researched in an attempt to minimize the pain and distress associated with these dental injections, varying from localized methods to distraction techniques. The localized methods include application of topical agents, altering the rate of injection, increasing the pH of local anesthetics by buffering and pretreatment with lasers. Instruments such as CCLA System (computer-controlled local anesthetic delivery system) and dental vibe are also available to make dental injections more comfortable. Studies have found that sweet flavored solutions, mainly 30% sucrose, given orally prior to cutaneous procedures can reduce discomfort in neonates undergoing heel sticks and venipuncture. Effectiveness of sucrose in the treatment of, procedural pain in newborns and babies has been verified in a Cochrane reviews.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This trial is a randomized clinical trial (parallel design 1:1).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

This research will be a double blinded study, where the patient (participant) and the statistician will be blind to the treatment groups.

Study Groups

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Effect of Pre-administered honey for Decreasing Pain of Dental Injections

The participants were asked to drink 5 mL of honey solution before injecting on the experimental side, the patient was asked to hold the solution in the mouth for a minute and then to spit it out .

Group Type EXPERIMENTAL

honey

Intervention Type DIETARY_SUPPLEMENT

analgesic effect of honey

topical anesthesia

benzocaine 20% gel was applied to the test sites on side of the jaw with a cotton tip applicator which was completely soaked for a period of 5 minutes.

Group Type OTHER

honey

Intervention Type DIETARY_SUPPLEMENT

analgesic effect of honey

Interventions

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honey

analgesic effect of honey

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Children within the age group 6 to 8 years were selected since the cognitive skills necessary for the use of visual analogue scale for pain assessment have not developed in children younger than 6 years of age.
2. Mobile deciduous second molars bilaterally that could be treated under infiltration anesthesia.

Exclusion Criteria

1. History of allergy to any components of local anesthetic agents used during the study.
2. Dental or dentoalveolar abscess.
3. Presence of any underlying systemic disease.
4. Immunocompromised patients.

Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes