The use of computerized anesthesia 'QuickSleeper 5' in children undergoing dental treatment

Evaluation of the effectiveness, pain, and complications of computerized intraosseous anesthesia in comparison to block anesthesia in children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN60155644

Enrollment

Registered

2022-01-12

Start date

2022-03-02

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Anesthetizing primary molars in children Oral Health

Interventions

This study will compare two types of dental anesthesia in children

the intervention type will QuickSleeper 5 (QS) and the control one will be an active control with an inferior alveolar nerve block (IANB). The study will include 52 participants aged between 7-9 year

Group 1: starts the first session with QS and the second session with IANB and Group 2: starts the first session with IANB and the second session with QS. A random allocation list will be carried ou

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy children who don't suffer from any systemic disease 2. Children aged between 6 - 9 years 3. Children who need bilateral pulpotomy for mandibular second primary molars 4. Cooperative children who are classified as definitely positive according to Frankel

Exclusion criteria

Exclusion criteria: 1. The existence of any chronic or acute infection in the area of injection 2. Children who have taken any analgesics in the last two days before the anesthesia 3. Children who have allergy to amide type of anesthetic solutions. 4. Children who are contraindicated to lidocaine injection (who suffer from liver cirrhosis, hepatitis) 5. Children who are contraindicated to vasoconstrictors injection (who suffer from hypertension, myocardial infarction, angina pectoris) 6. Children who do not show cooperation during the procedure

Design outcomes

Primary

Measure	Time frame
1. The effectiveness of both techniques of anesthesia will be studied during the pulp treatment procedure 2. Pain caused by the anesthesia will be studied using both subjective method (Simplified Faces Pain Scale S-FPS) immediately after the injection and objective method ( Face – Legs – Activity – Cry – Consolability scale FLACC) during the injection 3. Local complications of anesthesia will be studied at baseline, 24h, 48h and 1 week	—

Measure

Time frame

1. The effectiveness of both techniques of anesthesia will be studied during the pulp treatment procedure 2. Pain caused by the anesthesia will be studied using both subjective method (Simplified Faces Pain Scale S-FPS) immediately after the injection and objective method ( Face – Legs – Activity – Cry – Consolability scale FLACC) during the injection 3. Local complications of anesthesia will be studied at baseline, 24h, 48h and 1 week

—

Secondary

Measure	Time frame
Parental satisfaction will be studied after 1 week measured using a bespoke questionnaire	—

Countries

Syria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026