Pregabalin and Remifentanil - Analgesia and Ventilation

Pain Clinical Trial

Official title:

Pregabalin Has Additive Analgesic and Ventilatory Depressive Effects in Combination With Remifentanil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419405
• Other study ID #: 2011/1380-1
• Status: Completed
• Phase: Phase 4
• First received: June 30, 2011
• Last updated: September 11, 2014
• Start date: December 2011
• Est. completion date: March 2012

Study information

• Verified date: September 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Interventional

Clinical Trial Summary

In this experimental study on healthy volunteers we explored the effect of pregabalin alone and in combination with remifentanil on acute experimental pain and ventilatory function.

Description:

Pain during cold pressor test (CPT) was scored at all dose levels of remifentanil on a visual analogue scale (VAS 0-100 mm). Ventilatory function was measured by spirometry registering respiratory frequency (breaths/min), minute volume (L/min) and expiratory end-tidal carbon dioxide tension (mmHg).

Side effects such as nausea and sedation were registered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers,

• > 18 yrs < 55 yrs,

• negative pregnancy test

Exclusion Criteria:

• Pregnancy,

• nursing,

• known heart-, lung- or liver disease,

• kidney failure/peptic ulcers,

• use of liver enzyme-inducing medications,

• known allergy against the medications used in the trial,

• use of psychotropic drugs, analgesics or alcohol used the last 24 hours before the trial,

• body weight > 100 kg or 30% deviation from normal weight,

• participant in other studies during the last 2 months,

• individuals who do not master Norwegian language

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Pregabalin
hard capsule, 150 mg, 2 times, 2 days
• Remifentanil
50-90 min: TCI 0.6 ng/mL, 100-140 min: 1.2 ng/mL, 150-190 min: TCI 2.4 ng/mL
• sugar pill, saline infusion
hard capsule, 150 mg, 2 times, 2 days, saline infusion

Locations

Country	Name	City	State
Norway	Oslo Universitetssykehus, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain was caused by Cold Pressure Test	123 sec x 4	No
Secondary	Ventilatory function	Respiratory frequence (breath/min), tidal volume (mL), minute volume (L)and expiratory end-tidal carbon dioxide tension (mmHg)	10 min x 4	No
Secondary	Cognitive function	Cognitive function was tested using pc-tests like Cambridge Neuropsychological Test Automated Battery (CANTAB) and Stroop-test	4 min x 4	No