Measurement of the blood levels of the painkiller diclofenac in children following a single intravenous dose

A pharmacokinetic study of intravenous diclofenac (Dyloject®) in children undergoing routine surgery: an open-label, single-dose trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN65890744

Enrollment

Registered

2010-04-07

Start date

2010-06-01

Completion date

Unknown

Last updated

2017-07-24

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

Conditions

Pharmacokinetic study in children Surgery

Interventions

Children will be starved according to the UK National Paediatric Starvation Guideline produced by the Association of Paediatric Anaesthetists of GB & Ireland in conjunction with The Royal College of N

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children aged 2 to 8 years undergoing routine surgery including ear, nose and throat (ENT), orthopaedic, urological and general

Exclusion criteria

Exclusion criteria: 1. Previous allergic reaction to nonsteriodal anti-inflammatory drugs (NSAIDs) 2. Known bleeding tendency 3. Administration of a NSAID within the past 24 hours 4. History of liver disease, abnormal renal function and gastrointestinal bleeding 5. Children with special needs in view of consent issues

Design outcomes

Primary

Measure	Time frame
Plasma diclofenac assays	—

Secondary

Measure	Time frame
Measuring decaying plasma concentrations to estimate ancillary parameters such as Cmax, Tmax, UAC and T1/2	—

Countries

United Kingdom

Outcome results

None listed

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