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NCT Number: NCT04459377

Ketamine Analgesia in Third Molar Surgery

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 patient´s 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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Signs and Symptoms

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Käkkirurgiska kliniken, Falu lasarett

Falun, Dalarna County, 79182, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy or mild well-compensated systemic disease (ASA I & II)
  • 18- <45 years
  • 50-100 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

Treatment and study plan

S-ketamine

Drug

Patients are randomized to three groups. Randomization in blocks of six patients stratified by sex. A list of serial numbers and randomized group affiliation is produced which is open to the pharmacy's manufacturing staff and closed to the staff of the trial. The pharmacy prepares filled syringes with investigation drug in accordance with randomized group affiliation.

All groups are sedated with midazolam intravenously to a defined end point. A syringe pump with volume accuracy ± 2% injects the test drug (P, K1 or K2). One infusion set is coupled between the syringe and a three-way connection, which in turn is connected to a peripheral venous catheter (PVK). This PVK is also used for blood sampling. Blood is sampled at two occasions. Directly preoperatively and two hours after surgery. The third molar is surgically removed.

Sodium Chloride 0.9% Inj

Drug

Patients are randomized to three groups. Randomization in blocks of six patients stratified by sex. A list of serial numbers and randomized group affiliation is produced which is open to the pharmacy's manufacturing staff and closed to the staff of the trial. The pharmacy prepares filled syringes with investigation drug in accordance with randomized group affiliation.

All groups are sedated with midazolam intravenously to a defined end point. A syringe pump with volume accuracy ± 2% injects the test drug (P, K1 or K2). One infusion set is coupled between the syringe and a three-way connection, which in turn is connected to a peripheral venous catheter (PVK). This PVK is also used for blood sampling. Blood is sampled at two occasions. Directly preoperatively and two hours after surgery. The third molar is surgically removed.

Primary outcomes

  1. Pain (VAS)

    Time frame: 4 hours postoperatively

    Postoperative pain measured by Visual analog scale (VAS). From minimum 0mm to maximum 100mm. 0mm is no pain and 100mm is worst pain imaginable. Changes in Visual Analog Scale value from preoperatively to 4 hours postoperatively

Secondary outcomes

  1. Safety (Oxygen saturation)

    Time frame: Up to 2 hours.

    Change in oxygen saturation measured by pulseoximeter %. Intra individually and between the groups. From start to completion of the ketamine infusion.

Sponsors and collaborators

Lead sponsor

Dalarna County Council, Sweden

Other

Collaborators

  • Center for Clinical Research Dalarna, Sweden
  • Uppsala University

Registry information

Official study title

An Analysis of Ketamine Analgesia in Third Molar Surgery -Effects, Safety and Influence on Inflammatory Biomarkers in Plasma

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2020
Registry last updated
Oct 12, 2022

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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