NCT01142830

Brief 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

2.6 years

First QC Date

June 9, 2010

Last Update Submit

February 22, 2013

Conditions

Disruption or Dehiscence of Closure of Skull or Craniotomy

Keywords

CraniotomyPainChildren

Outcome Measures

Primary Outcomes (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)

    48 hs after surgery

Secondary Outcomes (3)

  • Analgesic Drugs

    48 hs after surgery

  • Complication of analgesic therapy

    48 hs after surgery

  • Methods of administration of analgesic drugs

    48 hs after surgery

Eligibility Criteria

Age1 Month - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ospedale Riuniti

Bergamo, Italy

Location

Policlinico Universitario

Catania, Italy

Location

Meyer Hospital

Florence, Italy

Location

Ospedale pediatrico Gaslini

Genova, Italy

Location

Istituto Nazionale Neurologico "Carlo Besta"

Milan, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

Policlinico Universitario Agostino Gemelli

Rome, Italy

Location

Ospedale Infantile Regina Margherita

Torino, Italy

Location

Related Publications (10)

  • 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.

    PMID: 15960721BACKGROUND

  • 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.

    PMID: 8799542BACKGROUND

  • 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.

    PMID: 14625709BACKGROUND

  • 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.

    PMID: 8837797BACKGROUND

  • 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.

    PMID: 16572646BACKGROUND

  • 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.

    PMID: 17410701BACKGROUND

  • 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.

    PMID: 11275389BACKGROUND

  • 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.

    PMID: 10667820BACKGROUND

  • 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.

    PMID: 14576554BACKGROUND

  • 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.

    PMID: 24467608DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pablo M. Ingelmo, MD

    San Gerardo Hospital

    PRINCIPAL INVESTIGATOR

  • Marta Somaini, MD

    San Gerardo Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Paediatric Anesthesia Coordinator

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 11, 2010

Study Start

March 1, 2009

Primary Completion

October 1, 2011

Study Completion

December 1, 2012

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

IT(8)