CompletedNot Applicable

Reducing Pain During Dental Nerve Block Injections in Children

Iraq166 participantsStarted 2025-02-01

Plain-language summary

Title of Study: Effect of External Cooling and Vibration, Counterstimulation, and Needle Type on Pain, Physiological, and Behavioral Outcomes During Inferior Alveolar Nerve Block in Pediatric Patients Why was this study done? The inferior alveolar nerve block (IANB) is a dental injection used to numb the lower jaw and teeth in children. Many children find this injection very painful and scary. Bad experiences can make them afraid of the dentist for years. This study was designed to test different ways to make the injection less painful and stressful for children. What did the researchers want to find out? They planned to compare three different methods to see which one works best to reduce pain, distress, and physical signs of fear (like a fast heartbeat) during the injection: External cooling + vibration (using a special device that cools and vibrates on the skin near the injection site) Counterstimulation (gentle tapping or pressing with a cotton roll near the injection site) A thinner needle (30-gauge instead of the standard 27-gauge) Standard method (27-gauge needle with no extra distraction) - this is the control group Who took part? The study enrolled 166 healthy children between the ages of 5 and 9 years who needed a lower jaw dental injection at Al-Mustansiriyah University Dental College. What happened during the study? Children were randomly placed into one of the four groups. All children received the same numbing medicine (2% lidocaine with epinephrine). Dentists gave the injection at the same speed for everyone. Researchers planned to measure: How much pain the child felt (using the Wong-Baker Faces scale, where children point to a face showing their pain level) How much pain the child showed (using the FLACC scale, which looks at face, legs, activity, crying, and comfort) Heart rate and oxygen level (using a finger clip device) How well the child cooperated (using the Frankl Behavior Rating Scale) What outcomes are being measured? The primary outcomes are children's self-reported pain and observer-rated pain behavior. Secondary outcomes include physiological responses (heart rate and oxygen saturation) and behavioral cooperation scores. The study will compare changes in these measures across the four intervention groups. What is the purpose of this research? The findings from this trial are expected to provide evidence to help dentists choose the most effective comfort measures to keep children calm and pain-free during lower jaw injections. The study aims to clarify whether distraction-based methods (cooling+vibration or counterstimulation) offer advantages over simply changing the needle gauge. Were there any side effects or risks? Safety is being monitored continuously throughout the procedure via pulse oximetry (oxygen saturation) and heart rate tracking. The interventions are considered low-risk, and children who show excessive distress are withdrawn and managed according to standard care. Who paid for this study? The study received no outside funding. The authors declared no conflicts of interest. Where was the study done? Department of Pediatric Dentistry, Al-Mustansiriyah University, Baghdad, Iraq.

Who can participate

Age range

5 Years – 9 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Children aged 5 to 9 years. Requiring dental procedures under inferior alveolar nerve block (IANB) anesthesia. Medically healthy children classified as American Society of Anesthesiologists (ASA) Class I or II. Baseline Frankl Behavior Rating of 2 or 3 (indicating cooperative or potentially cooperative behavior). Written informed consent obtained from parents or legal guardians. Age-appropriate assent obtained from the child. - Exclusion Criteria: Presence of systemic illness. Neurological disorders. Developmental conditions affecting pain perception. Previous traumatic dental injection experiences. Allergy or hypersensitivity to lidocaine with epinephrine. Significant respiratory or cardiovascular conditions (to avoid confounding physiological monitoring). Children who exhibit excessive distress during the procedure will be withdrawn and treated per standard care (this can be added as a withdrawal criterion if needed). \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Wong-Baker FACES Pain Rating Scale

Timeframe: Time Frame: Immediately post-procedure

FLACC Scale (Face, Legs, Activity, Cry, Consolability)

Timeframe: Periprocedural

Trial details

NCT IDNCT07667725

SponsorAl-Mustansiriyah University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-30

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