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Postoperative Pain in Scheduled Craniotomy

D

Dr. Negrin University Hospital

Status

Completed

Conditions

Craniotomy
Adverse Effect
Pain, Postoperative
Anxiety

Treatments

Drug: Metamizole

Study type

Observational

Funder types

Other

Identifiers

NCT04720248
Craneo-Negrín

Details and patient eligibility

About

Postoperative pain after craniotomy is frequent, with moderate-severe intensity. The fear to the side effects of opioids (nausea and vomiting and sedation), and NSAIDs (bleeding) makes it difficult to obtain adequate analgesic control in these patients. Preoperative anxiety may be associated with a poorer postoperative analgesic control, hindering the adequate postoperative evolution and increasing hospital stay and adverse effects. In this observational study, the investigators aimed to assess the postoperative analgesic management in patients undergoing scheduled craniotomy following routine clinical practice and to relate preoperative anxiety with the postoperative analgesic evaluation in this population.

Full description

Postoperative pain after craniotomy is frequent, with moderate-severe intensity. The fear to the side effects of opioids (nausea and vomiting and sedation), and NSAIDs (bleeding) makes it difficult to obtain adequate analgesic control in these patients. On the other hand, preoperative anxiety may be associated with a poorer postoperative analgesic control and hinder the adequate postoperative evolution. The main outcome is to assess the postoperative analgesic management in patients undergoing to craniotomy. Secondary objectives are to evaluate the appearance of postoperative side effects related to the analgesics and to assess the relationship between preoperative anxiety and postoperative pain

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients over 18 years old undergoing scheduled form for supratentorial craniotomy.
  • Signed informed consent.

Exclusion criteria

  • Mini Mental State Examination with a score less than or equal to 24 points.
  • Patients suffering from disabilities.
  • Patients who can not collaborate in the postoperative clinical assessment.
  • Patients who can not be assessed during the postoperative period by the Acute Pain Unit.

Trial design

73 participants in 2 patient groups

Metamizol postoperatively
Description:
Patients submitted to scheduled craniotomy receiving metamizol as analgesic medication postoperatively
Treatment:
Drug: Metamizole
Paracetamol or other analgesics postoperatively
Description:
Patients submitted to scheduled craniotomy receiving paracetamol or other drugs as analgesic medication postoperatively

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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