The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery
Information source: Glostrup University Hospital,Copenhagen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Gabapentin + dexamethasone + ketamine (Drug); Placebo (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Glostrup University Hospital,Copenhagen Official(s) and/or principal investigator(s):
Ole Mathiesen, MD, Principal Investigator, Affiliation: Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
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.
Clinical Details
Official title: The Effect of Gabapentin, Low Dose Ketamine, Paracetamol, NSAID and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Primary Total Hip Replacement
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a patient controlled pain treatment.(PCA)
Secondary outcome: Pain score (VAS)= at rest and at mobilisation.Postoperative Nausea and vomiting. Dizziness Sedation Nightmare and hallucinations. All measurements are taken at 2,4 and 24 h postoperatively.
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.
Eligibility
Minimum age: 55 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
- Epilepsy
- Medically treated diabetes
- Known kidney disease
- Daily use of analgetics
- Apart from NSAID
- Paracetamol or COX2 inhibitors
- Are treated with a antidepressive.
Locations and Contacts
Operations og Anæstesiologisk afd. Y, KAS Glostrup, Glostrup 2600, Denmark
Anæstesiafdelingen, Herning Centralsygehus, Herning 7400, Denmark
Additional Information
Starting date: October 2005
Ending date: May 2008
Last updated: May 14, 2008
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