Health TrialsbyHealthPanel

Effect of Starpen CCLAD in Injection and Extraction

ConditionPain Assessment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-8
SponsorCairo University

About this trial

The present study aims to evaluate the effect of computer-controlled Starpen automatic injection device versus the traditional syringe on pain perception during Injection of nerve block anesthesia and extraction of mandibular primary molars.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 6-8 years

Cooperative children (Rating 3 or 4 based on the Frankl behavior scale)

Medically fit children (ASA I).

Children are mentally capable of communication.

Disqualifiers

Children with a behavioral management problem.

Parental refusal of participation.

Children with a previous history of local anesthesia injection.

Medically unfit children (other than ASA I).

Trial design

Design model

Parallel

Treatments tested in this trial

  • computer-controlled Starpen Automatic Injection Device

    Device

    using computer-controlled Starpen Automatic Injection Device during inferior alveolar nerve block anesthesia and extraction of mandibular primary molars

  • Traditional Syringe

    Device

    nerve block anesthesia and extraction of mandibular primary molars using Traditional Syringe

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: control groupActive comparator 1 intervention
Group B: intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Subjective Pain perception during injection of local anesthesia

After injection, the child will be asked to choose a face from the Wong-Baker faces pain rating scale to express his pain experience after explaining the scale to him (Scores from 0 to 10),The scale shows a series of faces ranging from a happy face at (0) which represents "no hurt", to a crying face at (10), which represents "hurts like the worst pain imaginable . "the higher score means a worse outcome"

Time frame
immediately after the procedure(injection)

Secondary outcomes

1

objective pain perception during local anesthesia injection

During injection, the objective pain perception will be assisted by an external evaluator (the assistant supervisor), using the Faces, Legs, Activity, Cry, and Consolability scale with scores from (0 to 10) with score (0) represents that the patient is relaxed and comfortable and score (10) represents severe discomfort/pain "the higher score means a worse outcome"

Time frame
During the procedure (injection)
2

Subjective pain perception during the extraction

After extraction, the subjective pain perception will be recorded from the child by asking him to choose a face from the Wong-Baker faces pain rating scale to express his pain experience during the extraction after explaining the scale to him with scores from (0 to 10). The scale shows a series of faces ranging from a happy face at (0) which represents "no hurt", to a crying face at (10), which represents "hurts like the worst pain imaginable . "the higher score means a worse outcome"

Time frame
immediately after the procedure(extraction)
3

objective pain perception during extraction

During extraction, the objective pain perception will be assisted by an external evaluator (the assistant supervisor), using the Faces, Legs, Activity, Cry, and Consolability scale with scores from (0 to 10) with score (0) represents that the patient is relaxed and comfortable and score (10) represents severe discomfort/pain "the higher score means a worse outcome"

Time frame
During the procedure (extraction)
4

Physiological parameter (heart rate)

Physiological parameter (heart rate) with measuring unit(Beats per minute ) will be recorded at three-time points: baseline (10 minutes before the procedure), during injection, and extraction with a Pulse oximeter on the child's index finger

Time frame
at baseline(10 minutes before the procedure) and during both procedures (injection and extraction)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: