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

Phase 4

Recruiting

Conditions: curved spine
spinal fusion (surgery)
10028377
10005944

Registration Number: NL-OMON36529

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

- Age: 12 to 18 years
- an indication for scoliosis correction surgery, based on national criteria.
- physical status American Society of Anesthesiologist (ASA) I or II.
- able to operate a patient-controlled analgesic (PCA) device.

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.
- History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.or patients with known hypersensitivity to sulphonamides
- Active peptic ulceration or gastrointestinal (GI) bleeding.
- Inflammatory bowel disease.
- Congestive heart failure (NYHA II-IV).
- Established ischaemic heart disease, peripheral arterial disease or cerebrovascular disease.
- Treatment with lithium
- Spina Bifida

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the total amount of morphine consumption after 24<br /><br>hours. Morphine consumption will be measured 8, 16, 24, 36 and 48 hours after<br /><br>surgery.<br /><br>This is assessed from registration of the PCA pump. This pump is filled with a<br /><br>solution containing morphine 2 mg/ml. Morphine consumption is an objective<br /><br>outcome measure, in contrast with pain intensity scores, reported by the<br /><br>patient(8;20).<br /><br>The amount of morphine given per dose is corrected for the patient*s body<br /><br>weight. In this study population, including children ranging in age from 12 to<br /><br>18, body weight may extremely vary. To reliably compare morphine consumption<br /><br>among individuals, morphine dose will be adjusted to body weight (mg/kg body<br /><br>weight).</p><br>

Secondary Outcome Measures