curved spine spinal fusion (surgery)
Conditions
Interventions
Intervention: Parecoxib sodium (Dynastat®) intravenous injections, twice daily
on the day of surgery and the first postoperative day.
Sponsors
Sint Maartenskliniek
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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 outcome measure, in contrast with pain intensity scores, reported by the patient(8;20). 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 12 to 18, body weight may extremely vary. To reliably compare morphine consumption among individuals, morphine dose will be adjusted to body weight (mg/kg body weight). | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary study parameter is the pain intensity score, established by a visual analogue scale (VAS) on the first postoperative day. This is a Likert scale, ranging from 0 (no pain) to 10 (worst pain possible). Pain intensity is scored three times a day. A VAS score under 4 is defined as adequate pain relief. Highest pain at rest after 24 hours is considered as a secondary endpoint. Highest pain at rest after 48 hours will be recorded too. Safety is assessed by registration of adverse effects. The most important adverse effects of morphine are sedation and nausea. These effects will be most closely monitored, three times a day when pain en morphine consumption are reported too. Sedation is scored on a sedation scale (0 - 2). Nausea is reported being present or absent. Besides, use of anti-emetics is reported. Above, other adverse reactions including postoperative bleeding, constipation and gastrointestinal complaints are registered. | — |
Countries
Netherlands
Outcome results
None listed