Pregabalin and Remifentanil - Analgesia and Ventilation

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01419405

Enrollment

Registered

2011-08-18

Start date

2011-12-31

Completion date

2012-03-31

Last updated

2014-09-12

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

Conditions

Pain

Keywords

analgesia, acute experimental pain, cold pressor test, pregabalin, remifentanil

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.

Interventions

DRUGPregabalin

hard capsule, 150 mg, 2 times, 2 days

DRUGRemifentanil

50-90 min: TCI 0.6 ng/mL, 100-140 min: 1.2 ng/mL, 150-190 min: TCI 2.4 ng/mL

DRUGsugar pill, saline infusion

hard capsule, 150 mg, 2 times, 2 days, saline infusion

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pain intensity	123 sec x 4	Pain was caused by Cold Pressure Test

Secondary

Measure	Time frame	Description
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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026