Incidence of Pain After Craniotomy in Children (Brainpain)

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 .

Study Overview

• Status: Completed
• Conditions: Disruption or Dehiscence of Closure of Skull or Craniotomy

Detailed Description

Research in the adult population has evaluated incidence and severity of post-neurosurgical pain, and effectiveness of different post-neurosurgical analgesic regimens. Several small studies report the prevalence of some period of moderate to severe pain in the first 24 postoperative hours to be from 41 to 84 % of patients. In a prospective single academic medical institution study, adult patients treated with only acetaminophen and modest amounts of opioids on an as needed basis reported moderate to severe pain for the first 2 days after surgery. These findings have supported a growing consensus that perioperative pain associated with intracranial surgery may be more significant than initially appreciated. Factors that have been associated with increased pain after intracranial surgery include sex, younger age, surgical site, and surgical approach to the site. Pain may also be a significant factor in the quality of recovery from intracranial surgery. In contrast there are few studies describing the incidence or management of pain after neurosurgery in children.

• Study Type: Observational
• Enrollment (Actual): 218

Contacts and Locations

Study Locations

• Italy
  • Bergamo, Italy
    • Ospedale Riuniti
  • Catania, Italy
    • Policlinico Universitario
  • Firenze, Italy
    • Meyer Hospital
  • Genova, Italy
    • Ospedale Pediatrico Gaslini
  • Milano, Italy
    • Istituto Nazionale Neurologico "Carlo Besta"
  • Padova, Italy
    • Azienda Ospedaliera di Padova
  • Rome, Italy
    • Policlinico Universitario Agostino Gemelli
  • Torino, Italy
    • Ospedale Infantile Regina Margherita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

330 paediatric patients undergoing major craniotomy from the following Italian Hospitals: Policlinico Universitario Catania Ospedale Gaslini, Genova Ospedale Regina Margherita, Torino Ospedale Gemelli, Roma Ospedale Meyer, Firenze Ospedale Civile di Padova Ospedale Riuniti di Bergamo Ospedale San Gerardo di Monza

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: San Gerardo Hospital
• Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Royal Children's Hospital; Istituto Giannina Gaslini; University of Milano Bicocca; Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna; A.O. Ospedale Papa Giovanni XXIII; Policlinico Universitario, Catania; Ospedale Meyer; Ospedale Civile, Padova. Italy
• Investigators: Principal Investigator: Pablo M. Ingelmo, MD, San Gerardo Hospital; Study Chair: Marta Somaini, MD, San Gerardo Hospital

Publications and helpful links

General Publications

• 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. doi: 10.1097/00000542-200311000-00024.
• 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. doi: 10.3171/jns.2006.104.3.350.
• Quiney N, Cooper R, Stoneham M, Walters F. Pain after craniotomy. A time for reappraisal? Br J Neurosurg. 1996 Jun;10(3):295-9. doi: 10.1080/02688699650040179.
• 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. doi: 10.3171/jns.2007.106.2.210.
• de Gray LC, Matta BF. Acute and chronic pain following craniotomy: a review. Anaesthesia. 2005 Jul;60(7):693-704. doi: 10.1111/j.1365-2044.2005.03997.x.
• 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. doi: 10.1007/s00540-003-0182-8.
• 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. doi: 10.1097/00006123-199603000-00008.
• 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):317-322. doi: 10.1016/S0304-3959(00)00459-0.
• Koperer H, Deinsberger W, Jodicke A, Boker DK. Postoperative headache after the lateral suboccipital approach: craniotomy versus craniectomy. Minim Invasive Neurosurg. 1999 Dec;42(4):175-8. doi: 10.1055/s-2008-1053393.
• Bronco A, Pietrini D, Lamperti M, Somaini M, Tosi F, del Lungo LM, Zeimantz E, Tumolo M, Lampugnani E, Astuto M, Perna F, Zadra N, Meneghini L, Benucci V, Bussolin L, Scolari A, Savioli A, Locatelli BG, Prussiani V, Cazzaniga M, Mazzoleni F, Giussani C, Rota M, Ferland CE, Ingelmo PM. Incidence of pain after craniotomy in children. Paediatr Anaesth. 2014 Jul;24(7):781-7. doi: 10.1111/pan.12351. Epub 2014 Jan 28.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 9, 2010
• First Submitted That Met QC Criteria: June 10, 2010
• First Posted (Estimate): June 11, 2010

Study Record Updates

• Last Update Posted (Estimate): February 25, 2013
• Last Update Submitted That Met QC Criteria: February 22, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Pain; Children; Craniotomy
• Other Study ID Numbers: AR-HSG 01-2009