Pregabalin and Remifentanil - Analgesia and Ventilation

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: sugar pill, saline infusion; Drug: Pregabalin; Drug: Remifentanil

• Registration Number: NCT01419405
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-06-30
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-18
• Study Start: 2011-12
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-11
• Last Update Posted: 2014-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo/placebo	sugar pill, saline infusion	-
Pregabalin/placebo	Pregabalin	-
placebo/remifentanil	Remifentanil	-
Pregabalin/Remifentanil	Pregabalin	-
Pregabalin/Remifentanil	Remifentanil	-

Primary Outcome Measures

Name	Time	Method
Pain intensity	123 sec x 4	Pain was caused by Cold Pressure Test

Secondary Outcome Measures

Name	Time	Method
Ventilatory function	10 min x 4	Respiratory frequence (breath/min), tidal volume (mL), minute volume (L)and expiratory end-tidal carbon dioxide tension (mmHg)
Cognitive function	4 min x 4	Cognitive function was tested using pc-tests like Cambridge Neuropsychological Test Automated Battery (CANTAB) and Stroop-test

Trial Locations

Locations (1)

Oslo Universitetssykehus, Rikshospitalet; 🇳🇴 Oslo, Norway