Effect of paracetamol, low dose Ketamin, paracetamol, NSaid and dexametason on pain and opioid requirements in patients scheduled for primary total hip replacement

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002517-20-DK

Enrollment

Registered

2005-07-11

Start date

2005-08-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient scheduled for primary total hip replacement need postoperativ pain treatment. Morphine has side-effects: nause, vomiting, sedation and dizziness. These sideeffects are of course unpleasent for the patient and sometimes prolongs there stay in the hospital.

Interventions

Trade Name: Gabapentin Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Ketamin Pharmaceutical Form: Intravenous

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients scheduled for a total hip replacement - age between 55 and 85 - given there imformed concent - ASA 1-3 - BMI between 18 and 35 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients who - are unable to cooperate - does not speak and understand danish - has allergy for the drugs used in the trial - drug or alkohol abuse - epilepsi - medecaly treated diabetes - know kidney disease - daily use of analgesia - apart from NSAID, COX2 and paracetamol - treatment with anitidepressive

Design outcomes

Primary

Measure	Time frame
Main Objective: To improve the postoperative pain treatment, who have had done a total hip replacement, by using a new combination of secondary analgesics, and thereby hopefully minimizing there nedd for morphine postoperatively;Secondary Objective: To see if the well-known analgesic effect of gabapentin, ketamin, toradol and paracetamol can act synergistically in patients how have had done a total hip replacement.;Primary end point(s): The total amount og morphine needed postoperativly from 0-4 hours, and from 0-24 hours, administrated by patient controlled pain treatment.	—

Measure

Time frame

Main Objective: To improve the postoperative pain treatment, who have had done a total hip replacement, by using a new combination of secondary analgesics, and thereby hopefully minimizing there nedd for morphine postoperatively;Secondary Objective: To see if the well-known analgesic effect of gabapentin, ketamin, toradol and paracetamol can act synergistically in patients how have had done a total hip replacement.;Primary end point(s): The total amount og morphine needed postoperativly from 0-4 hours, and from 0-24 hours, administrated by patient controlled pain treatment.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026