Ketamine Analgesia in Third Molar Surgery

  • STATUS
    Recruiting
  • End date
    Dec 24, 2023
  • participants needed
    165
  • sponsor
    Dalarna County Council, Sweden
Updated on 24 January 2021
anesthesia
analgesics
analgesia
morphine
postoperative pain
ketamine
opioid
pain relief
local anesthesia
midazolam
local anesthetics
drug test
acute pain
pain relieving

Summary

BACKGROUND AND PURPOSE Outpatient surgery (day case surgery) is increasing. When the patients go home on the same day, this demands safe pain relief. A reduction of morphine (opioid) use is sought because of side effects and the dependency risk. An effective alternative to opioids is ketamine, which lacks the side effects of opioids but provides powerful analgesic effects.

METHOD At the start of surgery, Ketamine or placebo will be given in a vein to evaluate if the acute pain decreases significantly. Inflammation is known to cause pain. By measuring different proteins in the blood, the investigators want to understand how inflammation links to the pain. Wisdom tooth surgery provides significant post-operative pain and is a widely accepted pain model in drug studies. Patients referred for wisdom tooth surgery are asked to participate in the study. For statistical certainty, in total 165 persons will be enrolled to three groups. Two with active drug (different dose) and one placebo. Everyone gets local anesthesia. The completion of the study will be done in four years. The Ethics Review Board has approved the study.

CLINICAL RELEVANCE Effective pain relief after daily surgical procedures is important for patients safety and reducing the risk of long-term pain. It is also ethically necessary for the continued expansion of day case surgery. New knowledge of the mechanisms of pain increases the opportunities for individual and safe pain relief. Day case surgery is performed in all operating specialties, this might affects many patients nationally and internationally.

Details
Condition Postoperative, Pain, Post-Surgical Pain, Pain (Pediatric), Pain, Postoperative pain, Acute Pain Service, Post-Surgical Pain, Pain (Pediatric), ache
Treatment Sodium Chloride 0.9% Inj, S-ketamine
Clinical Study IdentifierNCT04459377
SponsorDalarna County Council, Sweden
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy or mild well-compensated systemic disease (ASA I & II)
- <45 years
-100 kg body weight

Exclusion Criteria

Medication drugs: analgesics, hypnotics (the last week before surgery), thyroid hormones, psychoactive drugs or monoamine oxidase inhibitors (MAO inhibitors)
Hypertension [> 150/95 mmHg in screening study]
Heart failure
Psychosis
Epilepsy
Hyperthyreosis
Myasthenia gravis
Glaucoma
Verified sleep apnea
Diabetes (insulin treated)
Porphyria
Pregnancy
Breast-feeding
Blood transmitted infections, such as HIV and hepatitis B and C
Known hypersensitivity to midazolam, ketamine, ibuprofen, or local anesthetics
Inability to obtain the requisite written or oral information
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