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

Not Applicable

Not yet recruiting

• Conditions: Analgesia
• Interventions: Dietary Supplement: honey

• Registration Number: NCT06393777
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-26
• Last Update Submitted: 2024-04-30
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-02
• Study Start: 2024-09
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
topical anesthesia	honey	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.
Effect of Pre-administered honey for Decreasing Pain of Dental Injections	honey	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 .

Primary Outcome Measures

Name	Time	Method
Pain perception during Dental injection Dental injection Pain perception during Dental injection	1 year	Wong-Baker ratting scale 0 happy ,2 hurts a little bit,4 "hurts a little more"6 hurts even more,8 hurts a whole lot"10hurts worst" Rating scale Wong-Baker Rating scale

Secondary Outcome Measures

Name	Time	Method
Child behavior during dental injection	1 year	The SEM(sound, eye, motor) scale Scale from (0-4)