Skip to main content
Clinical Trials/NCT00236223
NCT00236223
Terminated
Phase 4

The Effect of Gabapentin, Low Dose Ketamine, Paracetamol, NSAID and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Primary Total Hip Replacement

Glostrup University Hospital, Copenhagen2 sites in 1 country48 target enrollmentOctober 2005

Overview

Phase
Phase 4
Intervention
Gabapentin + dexamethasone + ketamine
Conditions
Pain, Postoperative
Sponsor
Glostrup University Hospital, Copenhagen
Enrollment
48
Locations
2
Primary Endpoint
The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a patient controlled pain treatment.(PCA)
Status
Terminated
Last Updated
17 years ago

Overview

Brief Summary

Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are 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.

Detailed Description

The effect on postoperative pain of the combination of preoperative gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15mg/kg versus placebo is investigated on patients having a hip alloplastic operation.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
May 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Glostrup University Hospital, Copenhagen

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for primary total hip replacement,
  • Between 55 and 85 years of age,
  • ASA 1-3 and BMI between 18 and 35.

Exclusion Criteria

  • Patients who are:
  • Unable to cooperate
  • Does not speak Danish
  • Has allergy for drugs used in the trial
  • Drug or alcohol abuse
  • Medically treated diabetes
  • Known kidney disease
  • Daily use of analgetics
  • Apart from NSAID
  • Paracetamol or COX2 inhibitors

Arms & Interventions

1

Intervention: Gabapentin + dexamethasone + ketamine

2

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: 0-24h

Secondary Outcomes

  • Pain score (VAS)= at rest and at mobilisation.(0-24h)
  • Postoperative Nausea and vomiting.(0-24h)
  • Dizziness(0-24h)
  • Sedation(0-24h)
  • Nightmare and hallucinations.(0-24h)
  • All measurements are taken at 2,4 and 24 h postoperatively.(0-24h)

Study Sites (2)

Loading locations...

Similar Trials