Skip to main content
OpenTrials
Completed

NCT Number: NCT00209495

Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients

Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Operations og Anæstesiologisk afd. Y, KAS Glostrup, Glostrup Municipality, Copenhagen, Denmark

Loading trial locations.

About this study

Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated. Primary outcome is 24 hours morphine usage.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women scheduled for abdominal hysterectomy, between the age of 18 and 75, ASA 1-2
  • BMI between 18-32.

Exclusion criteria

Patients who:

  • Are unable to cooperate
  • Has cancer ovarian
  • Does not speak Danish
  • Has allergy for drugs used in the trial
  • Has drug and medicine abuse
  • Epilepsy
  • Diabetes treated with medicine
  • Chronic pain condition
  • Daily use of antacids or analgesic
  • Known kidney disease
  • Use of antidepressive

Treatment and study plan

Pregabalin; Dexamethasone

Drug

Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

Primary outcomes

  1. The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA)

    Time frame: 0 - 24h

Secondary outcomes

  1. Pain Score (VAS) at rest and at mobilisation.

    Time frame: 0 - 24h

  2. Postoperative nausea and vomiting.

    Time frame: 0 - 24h

  3. Sedation.

    Time frame: 0 - 24h

  4. Dizziness.

    Time frame: 0 - 24h

  5. All measurements are taken at 2, 4 and 24 h postoperatively.

    Time frame: 0 - 24h

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Abdominal Hysterectomy.

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Feb 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.