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

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)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06393777
Enrollment
14
Registered
2024-05-01
Start date
2024-09-30
Completion date
2025-10-31
Last updated
2024-05-02

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

Conditions

Analgesia

Keywords

honey, injection, local anesthesia, pain

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.

Interventions

DIETARY_SUPPLEMENThoney

analgesic effect of honey

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain perception during Dental injection Dental injection Pain perception during Dental injection1 yearWong-Baker ratting scale 0 happy ,2 hurts a little bit,4 hurts a little more6 hurts even more,8 hurts a whole lot10hurts worst Rating scale Wong-Baker Rating scale

Secondary

MeasureTime frameDescription
Child behavior during dental injection1 yearThe SEM(sound, eye, motor) scale Scale from (0-4)

Other

MeasureTime frameDescription
heart rate during dental injectionthrough study completion, an average of 1 year.Pulse oximeter

Contacts

Primary ContactAlaa Ahmed Mohamed, B.D.
alaasalah199623@gmail.com01126160975
Backup ContactSoad abdelmoniem, Professor
soad.abdelmoniem@dentistry.cu.edu.eg01005654355

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026