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A double blind randomised placebo controlled study assessing the effect of intra-operative local anaesthetic administration on postoperative pain in adolescent children undergoing oral surgery under general anaesthetic to facilitate orthodontic treatment.

A double blind randomised placebo controlled study assessing the effect of intra-operative local anaesthetic administration on postoperative pain in adolescent children undergoing oral surgery under general anaesthetic to facilitate orthodontic treatment.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-000254-13-GB
Enrollment
Unknown
Registered
2008-05-02
Start date
2008-10-14
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Postoperative pain following oral surgery in 12 to 16 year olds MedDRA version: 9.1 Level: LLT Classification code 10024759 Term: Local anaesthetic MedDRA version: 9.1 Level: LLT Classification code 10054711 Term: Postoperative pain

Interventions

Trade Name: Lignospan Special Pharmaceutical Form: Injection* INN or Proposed INN: LIDOCAINE HYDROCHLORIDE CAS Number: 73789 Other descriptive name: Local Anaesthetic Concentration unit: % percent Con

Sponsors

Gwent Healthcare NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age 12 to16years Requiring surgery necessitating the raising of a mucoperiosteal flap and bone removal in at least one but not more than two sites Suitable for ambulatory surgery 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: Age under 12 years History of allergy to local anaesthetic, paracetamol or non-steroidal anti-inflammatory drugs ASA grade greater than 2 Body mass index greater than 35 Poorly controlled asthma The last three criteria are standard anaesthetic-based exclusions for ambulatory surgery

Design outcomes

Primary

MeasureTime frame
Main Objective: Does giving adolescent patients local anaesthetic while they are under general anaesthetic having oral surgery carried out reduce their post-operative pain experience?;Secondary Objective: ;Primary end point(s): Pain will be assessed up to two hours post surgery, that is just prior to discharge from the day surgery unit.—

Countries

United Kingdom

Outcome results

None listed

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