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

Pain, Postoperative Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00209495
• Other study ID #: SM1-04
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 28, 2008
• Start date: June 2005
• Est. completion date: February 2008

Study information

• Verified date: February 2008
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Pregabalin; Dexamethasone
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

Locations

Country	Name	City	State
Denmark	Operations og Anæstesiologisk afd. Y, KAS Glostrup	Glostrup	Copenhagen
Denmark	Herning Centralsygehus	Herning

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA)		0 - 24h	No
Secondary	Pain Score (VAS) at rest and at mobilisation.		0 - 24h	No
Secondary	Postoperative nausea and vomiting.		0 - 24h	No
Secondary	Sedation.		0 - 24h	No
Secondary	Dizziness.		0 - 24h	No
Secondary	All measurements are taken at 2, 4 and 24 h postoperatively.		0 - 24h	No