ClinicalTrials.gg
Status unknownNCT06393777Updated May 2, 2024

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

An interventional study of honey in Analgesia, sponsored by Cairo University. Status unknown. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-02.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
6 Years to 8 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Analgesia

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Keywords

  • honey
  • injection
  • local anesthesia
  • pain
03

In context

Agnosia

1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.

This study's planned enrollment of 14 is below the median of 75 across 1,089 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    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 .

    Dietary Supplement: honey

  • Other
    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.

    Dietary Supplement: honey

Interventions

  • Dietary supplementhoney

    analgesic effect of honey

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

Secondary outcomes

  1. Child behavior during dental injection

    The SEM(sound, eye, motor) scale Scale from (0-4)

    Time frame: 1 year

Other outcomes

  1. heart rate during dental injection

    Pulse oximeter

    Time frame: through study completion, an average of 1 year".

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 35656683 ↗
  • 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. PubMed 31650314 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2024; primary completion for Sep 2025, 12 months later.

Of 606 non-industry interventional studies with no phase under Agnosia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 12 months is close to that.

Counting every sponsor, half of 615 studies reached it within 12 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2024
First posted
May 1, 2024
StartEst.
Sep 2024
Primary completionEst.
Sep 2025
CompletionEst.
Oct 2025
Last update
May 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06393777
Lead sponsor
Cairo University
Responsible party
Alaa Ahmed Lotfy Mohamed Saleh (principle investigator, Cairo University) — Principal investigator
First posted
May 1, 2024
Start date
Sep 2024 (estimated)
Primary completion
Sep 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
May 2, 2024

Study contacts

Alaa Ahmed Mohamed, B.D.
Contact
alaasalah199623@gmail.com
01126160975
Soad abdelmoniem, Professor
Contact
soad.abdelmoniem@dentistry.cu.edu.eg
01005654355
Nourhan Omar Elgebaly, Lecturer
principal investigator · Outpatient clinic, department of Pediatric Dentistry, Faculty of Dentistry, Cairo University.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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