The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery | RxWiki

The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery

Overview[ - collapse ][ - ]

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	Pain, Postoperative
Intervention	Drug: Gabapentin + dexamethasone + ketamine Drug: Placebo
Phase	Phase 4
Sponsor	Glostrup University Hospital, Copenhagen
Responsible Party	Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier	NCT00236223
First Received	October 7, 2005
Last Updated	May 14, 2008
Last verified	May 2008

Tracking Information[ + expand ][ + ]

First Received Date	October 7, 2005
Last Updated Date	May 14, 2008
Start Date	October 2005
Estimated Primary Completion Date	May 2008
Current 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]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery
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
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Pain, Postoperative
Intervention	Drug: Gabapentin + dexamethasone + ketamine Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg Other Names: Anti-hyperalgesics Postoperative pain Drug: Placebo Matching placebo
Study Arm (s)	Experimental: 1 Placebo Comparator: 2

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	48
Estimated Completion Date	May 2008
Estimated Primary Completion Date	April 2008
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 - Epilepsy - Medically treated diabetes - Known kidney disease - Daily use of analgetics - Apart from NSAID - Paracetamol or COX2 inhibitors - Are treated with a antidepressive.
Gender	Both
Ages	55 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Denmark

Administrative Information[ + expand ][ + ]

NCT Number	NCT00236223
Other Study ID Numbers	SM2-05
Has Data Monitoring Committee	Yes
Information Provided By	Glostrup University Hospital, Copenhagen
Study Sponsor	Glostrup University Hospital, Copenhagen
Collaborators	Not Provided
Investigators	Principal Investigator: Ole Mathiesen, MD Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
Verification Date	May 2008

Locations[ + expand ][ + ]