Disruption or Dehiscence of Closure of Skull or Craniotomy Clinical Trial
— BrainpainOfficial title:
Prospective Multicenter Cohort Study Evaluating Incidence and Intensity of Postoperative Pain in Pediatric Patients After Craniotomy
The primary objective is to assess the incidence and severity of pain after major craniotomy
in paediatric patients (from 1 month to 10 years of age).
The secondary objective is to determine factors associated with significant pain following
paediatric neurosurgery .
| Status | Completed |
| Enrollment | 218 |
| Est. completion date | December 2012 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Month to 10 Years |
| Eligibility |
Inclusion Criteria: - Male and Female children from 1 month to 10 years Of age - American Society of Anaesthesiologists Classification (ASA) I-III - Scheduled for supratentorial or infratentorial craniotomy - Admission to an Intensive Care Unit, Neurosurgery ward or paediatric ward of one of the hospitals included - Children whose parents (or legal tutors) have given their informed written consent Exclusion Criteria: - Emergency surgery for multiple trauma. - Children requiring muscular relaxants during the postoperative period - Children whose parents (or legal tutors) denied their own consensus |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Italy | Ospedale Riuniti | Bergamo | |
| Italy | Policlinico Universitario | Catania | |
| Italy | Meyer Hospital | Firenze | |
| Italy | Ospedale pediatrico Gaslini | Genova | |
| Italy | Istituto Nazionale Neurologico "Carlo Besta" | Milano | |
| Italy | Azienda Ospedaliera di Padova | Padova | |
| Italy | Policlinico Universitario Agostino Gemelli | Rome | |
| Italy | Ospedale Infantile Regina Margherita | Torino |
| Lead Sponsor | Collaborator |
|---|---|
| San Gerardo Hospital | A.O. Ospedale Papa Giovanni XXIII, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna, Istituto Giannina Gaslini, Ospedale Civile, Padova. Italy, Ospedale Meyer, Policlinico Universitario Agostino Gemelli, Policlinico Universitario, Catania. Italy, Royal Children's Hospital, University of Milano Bicocca |
Italy,
De Benedittis G, Lorenzetti A, Migliore M, Spagnoli D, Tiberio F, Villani RM. Postoperative pain in neurosurgery: a pilot study in brain surgery. Neurosurgery. 1996 Mar;38(3):466-9; discussion 469-70. — View Citation
de Gray LC, Matta BF. Acute and chronic pain following craniotomy: a review. Anaesthesia. 2005 Jul;60(7):693-704. Review. — View Citation
Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. — View Citation
Irefin SA, Schubert A, Bloomfield EL, DeBoer GE, Mascha EJ, Ebrahim ZY. The effect of craniotomy location on postoperative pain and nausea. J Anesth. 2003;17(4):227-31. — View Citation
Jensen MP, Smith DG, Ehde DM, Robinsin LR. Pain site and the effects of amputation pain: further clarification of the meaning of mild, moderate, and severe pain. Pain. 2001 Apr;91(3):317-22. — View Citation
Klimek M, Ubben JF, Ammann J, Borner U, Klein J, Verbrugge SJ. Pain in neurosurgically treated patients: a prospective observational study. J Neurosurg. 2006 Mar;104(3):350-9. — View Citation
Koperer H, Deinsberger W, Jödicke A, Böker DK. Postoperative headache after the lateral suboccipital approach: craniotomy versus craniectomy. Minim Invasive Neurosurg. 1999 Dec;42(4):175-8. — View Citation
Leslie K, Troedel S, Irwin K, Pearce F, Ugoni A, Gillies R, Pemberton E, Dharmage S. Quality of recovery from anesthesia in neurosurgical patients. Anesthesiology. 2003 Nov;99(5):1158-65. — View Citation
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postoperative Pain | Pain at rest and in activity will be evaluated using one or more of the following instruments: FLACC scale for non ventilated children from 1month to 6 years of age or non ventilated children of all ages not could not be evaluated with the Numeric Rating Scale (NRS) (a =4 score is considered pain) Numeric Rating Scale (NRS) for non ventilated children from 7 to 10 years of age (a = 4 score is considered pain) COMFORT scale for ventilated children from 1month to 10 years of age (a = 27 score is considered distress) |
48 hs after surgery | No |
| Secondary | Analgesic Drugs | 1. Type and dose of analgesic therapy used including intra operative administration Local anesthetic infiltration (dose and time related to surgery) Scalp block (dose and time related to surgery) Paracetamol NSAID Weak opioids (i.e. codeine, tramadol) Strong opioids (i.e. morphine, fentanyl) Other drugs including ketamine, clonidine |
48 hs after surgery | No |
| Secondary | Complication of analgesic therapy | Complications that might be associated with analgesic therapy and could conceivably affect recovery from intracranial surgery, such as postoperative nausea and vomiting, excessive sedation, and respiratory depression will be considered and registered in the collecting data form | 48 hs after surgery | No |
| Secondary | Methods of administration of analgesic drugs | Continuous infusion PCA: Patients Controlled Analgesia Nurse controlled analgesia IV intermittent bolus Enteral intermittent: Oral, rectal Other (transdermal, etc.) |
48 hs after surgery | No |