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Completed

NCT Number: NCT00785863

Modulation of Remifentanil-induced Postinfusion Hyperalgesia

In addition to alleviate pain there is growing evidence that µ-opioids enhance pain. This problem is known as opioid induced hyperalgesia(OIH).The NMDA receptor is involved in opioid induced hyperalgesia it may be possible to block OIH by cyclooxygenase inhibitors. This has been demonstrated with parecoxib, a COX-II inhibitor, in a experimental pain model.Both COX-1 and COX-2 are expressed in the spinal cord. It would be of interest to investigate whether a COX-1 preferring inhibitor like ketorolac also can reduce opioid induced hyperalgesic in this experimental pain model.

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Key information

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Ullevaal University Hospital

Oslo, 0407, Norway

About this study

Remifentanil is an fast acting opioid which has become very popular to use during surgery.

There are studies, both experimental 1-3 and clinical 4;5, which indicate that remifentanil after end of infusion trigger enhanced pain experience and enhanced opioid consumption postoperatively.

Therefore it is important to look at possibilities to block this enhanced pain experience (opioid induced hyperalgesia - OIH). Ketamin has demonstrated to block this effect 5;6 through the NMDA receptor. Unfortunately ketamin has some seriously side-effects like hallucinations, and is therefore not suitable in ordenary clinical use.

Recently, it has been demonstrated that parecoxib (a COX-2 inhibitor) can prevent remifentanil-induced postinfusion hyperalgesia in a study on healthy volunteers.7 COX-2 inhibitors have some disadvantages because of the longterm adverse effects like cardiac arrest. Therefore it would be of interest to look at a COX-1 preferring NSAID, like ketorolac, to see if also non-selective NSAIDs can partly block remifentanil-induced postinfusion hyperalgesia.

To investigate this and to provoke pain and secondary hyperalgesia we use an intradermal electrical pain model which is well established.1;7-9 Detailed description of this model look at reference 7. H0 : Parecoxib prevents remifentanil postinfusion secondary hyperalgesi. Ketorolac does not prevent remifentanil postinfusion secondary hyperalgesi HA : Parecoxib and ketorolac prevent remifentanil postinfusion secondary hyperalgesi.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

  • Allergy to the drugs used in the study

Treatment and study plan

Placebo

Other

Placebo IV before placebo infusion

Remifentanil

Drug

placebo IV and remifentanil infusion

Other names: Ultiva

Ketorolac and remifentanil

Drug

Ketorolac IV and remifentanil infusion

Other names: Toradol

Parecoxib and remifentanil

Drug

Parecoxib IV and remifentanil infusion

Other names: Dynastat

Primary outcomes

  1. H0 : Parecoxib prevents remifentanil postinfusion secondary hyperalgesi. Ketorolac does not prevent remifentanil postinfusion secondary hyperalgesi.

    Time frame: during the study

Secondary outcomes

  1. HA : Parecoxib and ketorolac prevent remifentanil postinfusion secondary hyperalgesi.

    Time frame: During the study

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Collaborators

  • Rikshospitalet University Hospital
  • University of Oslo

Registry information

Official study title

Modulation of Remifentanil-induced Analgesia and Postinfusion Hyperalgesia by Parecoxib or Ketorolac in Humans

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 5, 2008
Registry last updated
Jul 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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