The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery - Full Text View

Sponsor:	Glostrup University Hospital, Copenhagen
Information provided by:	Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:	NCT00236223

Purpose

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.

Condition	Intervention	Phase
Pain, Postoperative	Drug: Gabapentin + dexamethasone + ketamine Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Dizziness and Vertigo Nausea and Vomiting Surgery

Drug Information available for: Dexamethasone Dexamethasone acetate Gabapentin Doxiproct plus Ketamine hydrochloride Dexamethasone Sodium Phosphate Ketamine

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain score (VAS)= at rest and at mobilisation. [ Time Frame: 0-24h ] [ Designated as safety issue: No ]
Postoperative Nausea and vomiting. [ Time Frame: 0-24h ] [ Designated as safety issue: No ]
Dizziness [ Time Frame: 0-24h ] [ Designated as safety issue: No ]
Sedation [ Time Frame: 0-24h ] [ Designated as safety issue: No ]
Nightmare and hallucinations. [ Time Frame: 0-24h ] [ Designated as safety issue: No ]
All measurements are taken at 2,4 and 24 h postoperatively. [ Time Frame: 0-24h ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	October 2005
Study Completion Date:	May 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Gabapentin + dexamethasone + ketamine Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg
2: Placebo Comparator	Drug: Placebo Matching placebo

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

Ages Eligible for Study:	55 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236223

Locations

Denmark
Operations og Anæstesiologisk afd. Y, KAS Glostrup
Glostrup, Denmark, 2600
Anæstesiafdelingen, Herning Centralsygehus
Herning, Denmark, 7400

Sponsors and Collaborators

Glostrup University Hospital, Copenhagen

Investigators

Principal Investigator:

Ole Mathiesen, MD

Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark

More Information

No publications provided

Responsible Party:	Dept of anaesthesiology ( Ole Mathiesen )
Study ID Numbers:	SM2-05
Study First Received:	October 7, 2005
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00236223 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics; Denmark: Danish Medicines Agency; Denmark: Danish Dataprotection Agency

Keywords provided by Glostrup University Hospital, Copenhagen:

Primary hip replacement
Gabapentin
Dexamethasone
Ketamine
Multimodal postoperative analgesia.

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Antineoplastic Agents
Gabapentin
Physiological Effects of Drugs
Psychotropic Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Calcium Channel Blockers
Antiparkinson Agents
Antiemetics
Anesthetics
Pain

Excitatory Amino Acid Agents
Hormones
Membrane Transport Modulators
Signs and Symptoms
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Ketamine
Analgesics
Dexamethasone acetate
Pain, Postoperative
Excitatory Amino Acid Antagonists
Anesthetics, Intravenous
Tranquilizing Agents
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on February 08, 2010