Assessing the effectiveness and safety of parecoxib compared to placebo in pain relief children undergoing scoliosis surgery
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Spinal fusion is the most widely performed and painful surgery for idiopathic
scoliosis in children and adolescents. Currently, next to paracetamol, high
doses of opioids are necessary for pain relief, resulting in adverse events
like nausea and sedation.
Non-steroidal anti-inflammatory drugs (NSAIDs) could be an opioid sparing
option for analgesic treatment. Concerns related to increased postoperative
bleeding have limited their use. A cyclooxygenase (COX)-2 inhibitor does not
have this disadvantage.
Intravenous administration is preferred because of postoperative nausea. A
candidate for postoperative analgesia would be the intravenously administered
COX-2 selective parecoxib. No study has been performed yet for the indication
postoperative pain after scoliosis surgery in children. Therefore, a study is
performed to establish the effectiveness and safety of the parenterally given,
selective COX-2 inhibitor parecoxib in analgesia after scoliosis surgery.
Study objective
Assessing the effectiveness and safety of parecoxib compared to placebo in pain
relief children undergoing scoliosis surgery
Study design
A randomised double blinded placebo controlled trial
Intervention
Intervention: Parecoxib sodium (Dynastat®) intravenous injections, twice daily
on the day of surgery and the first postoperative day.
Study burden and risks
Effectiveness and safety of parecoxib have not been studied yet in this
population. Therefore, risks associated with participation in this study cannot
adequately be estimated. However, based on results from studies in adults,
benefits are expected to override risks.
No extra blood samples are needed for this trial. The measurements, recorded
during the study, are protocol-guided and already general practice in this
hospital. No extra tests are necessary. A possible increased risk of bleeding
will be closely monitored. Other adverse events or other risks are not
expected.
Hengstdal 3
6522JV Nijmegen
NL
Hengstdal 3
6522JV Nijmegen
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-023844-34-NL |
| CCMO | NL33293.091.10 |