Effectiveness and safety of parecoxib in children undergoing scoliosis surgery compared to placebo: a double-blinded randomised controlled trial - Effectiveness and safety of parecoxib in children after scoliosis surgery

Conditions: Postoperative pain in children after scoliosis surgergy (spinal fusion).The morphine consumption on the first two postoperative days will be assessed.Children: <18 years old, ASA I or II
MedDRA version: 12.1Level: PTClassification code 10039727Term: Scoliosis surgery

Registration Number: EUCTR2010-023844-34-NL

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Children (aged under 18 years),
scheduled for spinal fusion at the Sint Maartenskliniek,
ASA I – II,
able to operate a patient-controlled device
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

any known allergy to NSAIDs or morphine,
severe hepatic impairment or renal impairment,
sever asthma requiring at least one hospitalisation,
ASA III of IV

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assessing the effectiveness of parecoxib compared to placebo in pain relief children undergoing scoliosis surgery<br><br>;Secondary Objective: Assessing the safety of parecoxib compared to placebo in pain relief children undergoing scoliosis surgery<br>;Primary end point(s): The main study parameter is the total amount of morphine consumption after 24 hours. Morphine consumption will be measured 8, 16, 24, 36 and 48 hours after surgery. <br>This is assessed from registration of the PCA pump. This pump is filled with a solution containing morphine 2 mg/ml. Morphine consumption is an objective measure. <br>The amount of morphine given per dose is corrected for the patient’s body weight. In this study population, including children ranging in age from 5 to 17, body weight may extremely vary. To reliably compare morphine consumption among individuals, morphine dose will be adjusted to body weight (mg/kg body weight).<br>

Secondary Outcome Measures