Reducing Pain During Dental Nerve Block Injections in Children

NCT07667725 | Completed DMC

• 1 other identifier: MUPEDO4
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Anxiety; Inferior Alveolar Nerve; Pain Management

Keywords

inferior alveolar nerve block; pain management; cooling and vibration; Pediatric dentistry; needle gauge

Outcome Measures

Primary Outcomes (2)

• Wong-Baker FACES Pain Rating Scale

  Description: Self-reported pain intensity assessed by the child immediately after the inferior alveolar nerve block (IANB) injection. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain." Children select the face that best matches their pain experience.

  Time Frame: Immediately post-procedure

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

  Description: Observer-rated behavioral pain assessment scored by a blinded, calibrated observer during the injection procedure. The scale evaluates five behavioral categories (Face, Legs, Activity, Cry, Consolability), each scored 0-2, for a total score ranging from 0 to 10. Higher scores indicate greater pain and distress.

  Periprocedural

Secondary Outcomes (3)

• Heart Rate (bpm)

  Periprocedural

• Oxygen Saturation

  Periprocedural

• Frankl Behavior Rating Scale

  Periprocedural

Study Arms (4)

Cooling + Vibration

EXPERIMENTAL

A thermomechanical device (Buzzy™, MMJ Labs, USA) is positioned externally at the injection site for 30-60 seconds before needle insertion and remains in place during anesthetic deposition, providing simultaneous vibration and cooling. The inferior alveolar nerve block (IANB) is performed using 2% lidocaine with 1:100,000 epinephrine delivered at a controlled rate of approximately 1 mL/minute.

Device: Buzzy Device; Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000

Counterstimulation

EXPERIMENTAL

Gentle manual tapping and pressure with a cotton roll adjacent to the injection site is applied throughout the injection to provide non-noxious tactile input and attentional distraction. The IANB is performed using 2% lidocaine with 1:100,000 epinephrine delivered at a controlled rate of approximately 1 mL/minute.

Procedure: Counterstimulation; Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000

30-Gauge Needle

EXPERIMENTAL

A standard IANB is performed using a 30-gauge long needle without additional distraction techniques. The anesthetic used is 2% lidocaine with 1:100,000 epinephrine delivered at a controlled rate of approximately 1 mL/minute.

Device: 30-Gauge Needle; Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000

Standard 27G Needle (Control)

ACTIVE COMPARATOR

A routine IANB is performed using a standard 27-gauge long needle as the control condition. The anesthetic used is 2% lidocaine with 1:100,000 epinephrine delivered at a controlled rate of approximately 1 mL/minute. This represents the current standard of care.

Device: 27-Gauge Needle; Drug: Lidocaine hydrochloride 2% with epinephrine 1:100 000

Interventions

Buzzy Device DEVICE

A thermomechanical device providing simultaneous vibration and cooling, placed externally at the injection site for 30-60 seconds before and during local anesthetic deposition.

Cooling + Vibration

Counterstimulation PROCEDURE

Gentle manual tapping and pressure applied with a cotton roll adjacent to the injection site throughout the injection to provide tactile distraction.

Counterstimulation

30-Gauge Needle DEVICE

A 30-gauge long dental needle used for the inferior alveolar nerve block.

30-Gauge Needle

27-Gauge Needle DEVICE

A 27-gauge long dental needle used for the inferior alveolar nerve block (standard control).

Standard 27G Needle (Control)

Lidocaine hydrochloride 2% with epinephrine 1:100 000 DRUG

2% lidocaine with 1:100,000 epinephrine administered as a local anesthetic for the inferior alveolar nerve block at 1 mL/min.

30-Gauge Needle; Cooling + Vibration; Counterstimulation; Standard 27G Needle (Control)

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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. -

You may not qualify if:

• 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).

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

Al-Mustansiriyah University

Baghdad, Rusafa, 10001, Iraq

Location

Related Publications (4)

• Eleraky RH, Mohy ElDin M, Ibrahim Y, Soliman RS, Wahba NA. Effect of needle bevel type on pain perception in children during inferior alveolar nerve block anesthesia: randomized controlled clinical trial. BMC Oral Health. 2025 Sep 2;25(1):1400. doi: 10.1186/s12903-025-06731-7.

  PMID: 40898243 BACKGROUND

• Prado IM, Carcavalli L, Abreu LG, Serra-Negra JM, Paiva SM, Martins CC. Use of distraction techniques for the management of anxiety and fear in paediatric dental practice: A systematic review of randomized controlled trials. Int J Paediatr Dent. 2019 Sep;29(5):650-668. doi: 10.1111/ipd.12499. Epub 2019 Apr 25.

  PMID: 30908775 BACKGROUND

• Turan Y, Senirkentli GB, Cekmen N, Tirali E, Cakmak E. Retrospective Evaluation of the Effects of Local Anesthesia Before Tooth Extraction Procedures under General Anesthesia on Physiologic Parameters and Postoperative Bleeding in Children. Niger J Clin Pract. 2024 Jun 1;27(6):723-731. doi: 10.4103/njcp.njcp_708_23. Epub 2024 Jun 29.

  PMID: 38943296 BACKGROUND

• Roberts JF, Curzon ME, Koch G, Martens LC. Review: behaviour management techniques in paediatric dentistry. Eur Arch Paediatr Dent. 2010 Aug;11(4):166-74. doi: 10.1007/BF03262738.

  PMID: 20840826 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine; Epinephrine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor was blinded to group assignment. Participants, care providers (dentists administering the injection), and the investigator were not masked due to the nature of the interventions (visible device, manual tapping, or needle type).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, College of Dentistry, Al-Mustansiriyah University

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 25, 2026
• Study Start: February 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)