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

Analgesia Clinical Trial

Official title:

Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain Associated With Dental Injections (Infiltration) Prior to Extraction in 6-8 Years Old Children In Comparison to Topical Anesthesia. (RCT)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06393777
• Other study ID #: pain of dental injection pedo
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: Alaa Ahmed Mohamed, B.D.
• Phone: 01126160975
• Email: alaasalah199623[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 14
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

Dietary Supplement:
• honey
analgesic effect of honey

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

Gumus H, Aydinbelge M. Evaluation of effect of warm local anesthetics on pain perception during dental injections in children: a split-mouth randomized clinical trial. Clin Oral Investig. 2020 Jul;24(7):2315-2319. doi: 10.1007/s00784-019-03086-6. Epub 2019 Oct 24. — View Citation

Janiani P, Gurunathan D. Effectiveness of Pre-administered Natural Sweet-tasting Solution for Decreasing Pain Associated with Dental Injections in Children: A Split-mouth Randomized Controlled Trial. J Contemp Dent Pract. 2021 Dec 1;22(12):1434-1437. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	heart rate during dental injection	Pulse oximeter	through study completion, an average of 1 year".
Primary	Pain perception during Dental injection Dental injection Pain perception during Dental injection	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	1 year
Secondary	Child behavior during dental injection	The SEM(sound, eye, motor) scale Scale from (0-4)	1 year