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Disruption or Dehiscence of Closure of Skull or CraniotomyBrainpainNCT01142830

Incidence of Pain After Craniotomy in Children

An observational study of Disruption or Dehiscence of Closure of Skull or Craniotomy, run by San Gerardo Hospital at 8 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 . Read more about this study

Who is it for?
Ages 1 month to 10 years
How many people
218 participants
Where
8 sitesItaly
Study dates
Mar 2009to Dec 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 10 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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

Who cannot join

  • Emergency surgery for multiple trauma.
  • Children requiring muscular relaxants during the postoperative period
  • Children whose parents (or legal tutors) denied their own consensus

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Italy8 sites

  • Ospedale Riuniti

    Bergamo

  • Policlinico Universitario

    Catania

  • Meyer Hospital

    Florence

  • Ospedale pediatrico Gaslini

    Genova

  • Istituto Nazionale Neurologico "Carlo Besta"

    Milan

  • Azienda Ospedaliera di Padova

    Padova

  • Policlinico Universitario Agostino Gemelli

    Rome

  • Ospedale Infantile Regina Margherita

    Torino

Other trials in Italy

About this study

Official 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 .

Read the 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.

Keywords
Craniotomy, Pain, Children
Medical subject headings
Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 48 hs after surgery

Secondary outcomes (3)

  1. 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

    Measured: 48 hs after surgery

  2. 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

    Measured: 48 hs after surgery

  3. 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.)

    Measured: 48 hs after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2010 (estimated)
  2. Study startMar 2009
  3. Primary completionOct 2011
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01142830
Sponsor's protocol ID
AR-HSG 01-2009
Acronym
Brainpain
Status last verified
Feb 2013
First submitted
9 Jun 2010
Last updated
25 Feb 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15960721

  • 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.

    PubMed 8799542

  • 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.

    PubMed 14625709

  • 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.

    PubMed 8837797

  • 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.

    PubMed 16572646

  • 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.

    PubMed 17410701

  • 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.

    PubMed 11275389

  • 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.

    PubMed 10667820

  • 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.

    PubMed 14576554

  • 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.

    PubMed 24467608

Questions about this trial

What is this clinical trial studying?

An observational study of Disruption or Dehiscence of Closure of Skull or Craniotomy, run by San Gerardo Hospital at 8 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain (time frame: 48 hs after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01142830, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013.

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