The use of local anasthesia for pain control in children undergoing dental general anaesthesia - Pain control in children having a dental general anaesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004394-28-GB

Enrollment

Registered

2005-02-15

Start date

2005-01-07

Completion date

Unknown

Last updated

2018-11-26

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

Conditions

Patients requiring dental restorations of decayed teeth and dental extractions of teeth with dental abscesses.

Interventions

Trade Name: Xylocaine 2% with 1:80000 adrenaline Product Name: Xylocaine 2% with Adrenaline 1:80000 Pharmaceutical Form: Solution for injection INN or Proposed INN: Lidocaine hydrochloride Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children: AGED 5-12 YEARS ASA 1 and ASA 2 Attending Guy's Hospital for dental treatment under DGA Treatment involving symmetrical extractions +/- restorative care Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with learning dental / mental disabilities. Patients at risk of infective endocarditis Patients who are immunocompromised Patients with acute infections

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effectiveness of pre-emptive analgesia for pain control in children undergoing a denal general anaesthesia (DGA);Secondary Objective: Assess the effectiveness and acceptability of intra-crestal analgesia as a method of pain control in children having dental restorations/extractions under DGA;Primary end point(s): PATIENTS AND METHODS Patient selection 1. Healthy children, ASA I and II, (those suitable for day case dental general anaesthetic) between 5-12 years of age, requiring symmetrical extractions +/- restorations under day-stay DGA. 2. Those patient's with special needs (those at risk of endocarditis) will be excluded from the study. 3. Those children who have learning disabilities, who would be unable of completing the questionnaires. Methods 1. ICA, will be administered on one side of the patient's mouth only, by random assignment. 2. Each subject will act as his/her own control using the half-mouth study design. The test side will receive ICA and the control side will not. PROCEDURE Pre-operatively 1. The principle investigator (JJ) would carry out all the pre-operative assessments. 2. An information sheet will be prepared for the parents/ carer and the child. 3. Previous medical and dental history would be obtained, including details about previous GA/LA experience and complications associated with either. 4. Pre-operative anxiety levels of the patients would be assessed using the Venham Picture Scale or Facial Image Scale. 5. The anxiety levels of the parents would be measured by the Corah Anxiety Scale. 6. Patient's pre-operative behaviour would be assessed using the Frankl Scale. 7. Pre-operative waiting time of the patient on the day of the GA would be recorded. 8. Patient's pre-operative blood pressure, heart rate and pulse would be measured. Intra-operatively 1. Test side of ICA would be randomly chosen. 2. Local anaesthetic (2% lignocaine + 1:80,000 adrenaline) would be administered intra crestally just prior to e	—

Measure

Time frame

Main Objective: To evaluate the effectiveness of pre-emptive analgesia for pain control in children undergoing a denal general anaesthesia (DGA);Secondary Objective: Assess the effectiveness and acceptability of intra-crestal analgesia as a method of pain control in children having dental restorations/extractions under DGA;Primary end point(s): PATIENTS AND METHODS Patient selection 1. Healthy children, ASA I and II, (those suitable for day case dental general anaesthetic) between 5-12 years of age, requiring symmetrical extractions +/- restorations under day-stay DGA. 2. Those patient's with special needs (those at risk of endocarditis) will be excluded from the study. 3. Those children who have learning disabilities, who would be unable of completing the questionnaires. Methods 1. ICA, will be administered on one side of the patient's mouth only, by random assignment. 2. Each subject will act as his/her own control using the half-mouth study design. The test side will receive ICA and the control side will not. PROCEDURE Pre-operatively 1. The principle investigator (JJ) would carry out all the pre-operative assessments. 2. An information sheet will be prepared for the parents/ carer and the child. 3. Previous medical and dental history would be obtained, including details about previous GA/LA experience and complications associated with either. 4. Pre-operative anxiety levels of the patients would be assessed using the Venham Picture Scale or Facial Image Scale. 5. The anxiety levels of the parents would be measured by the Corah Anxiety Scale. 6. Patient's pre-operative behaviour would be assessed using the Frankl Scale. 7. Pre-operative waiting time of the patient on the day of the GA would be recorded. 8. Patient's pre-operative blood pressure, heart rate and pulse would be measured. Intra-operatively 1. Test side of ICA would be randomly chosen. 2. Local anaesthetic (2% lignocaine + 1:80,000 adrenaline) would be administered intra crestally just prior to e

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Countries

United Kingdom

Outcome results

None listed

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