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Inhaled Nebulised S(+)-Ketamine for Postoperative Analgesia

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ClinicalTrials.gov Identifier: NCT02397356
Recruitment Status : Withdrawn (Lack of study personnel)
First Posted : March 24, 2015
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

Brief Summary:

Ketamine has been administrated via the intravenous, intramuscular, subcutaneous, rectal, oral, transdermal, intranasal, sublingual, transmucosal, epidural, intrathecal, and intra-articular routes. Pharmacokinetic properties of inhaled ketamine have not been studied officially, but one of the investigators researchers has tested nebulized ketamine on himself with repeated painful stimulus and monitoring applied. Based on this experiment, analgesic effect is roughly estimated to begin in 3 minutes.Ketamine has been used successfully to treat acute pain in intranasal form. The primary purpose of this study is to evaluate whether nebulised S(+)-ketamine carries potential as a an analgesic bypassing first pass metabolism and without the need for intravenous access. Secondary aim is to assess the duration of analgesia obtained by nebulized S-ketamine. Thirdly, the aim is to evaluate whether inhaled nebulized ketamine decreases the need for rescue analgesia during PACU care. The subjects are recruited among patients coming in for a surgical intervention (orthopedic, gastrointestinal, plastic or urologic surgery) and needing further observation in postoperative care unit (PACU).

It was calculated that sample size of 8 subjects per group would be required to achieve statistical power of 80% and detect a difference of 3 units in NRS-values with standard deviation of 2 units and type I error of 5%. To prepare for possible dropouts, total of 20 subjects will be recruited (10 in each group).

Patients will receive either nebulized placebo (i.e. saline) or ketamine (Ketanest-S) when they require pain alleviation in the PACU. Dosage of ketamine is 1 mg/kg. Patients will be randomized into two groups so that other group's first inhalation contains ketamine and second inhalation placebo and in the opposite order.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Ketamine first AB Drug: Placebo first BA Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Inhaled Nebulised S(+)-Ketamine for Postoperative Analgesia
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine first AB
Patients in this group will first receive a dose of ketamine in the nebulised form when they ask for pain relief. The second time they ask for pain relief, they will receive physiological salt in the nebulised form.
Drug: Ketamine first AB
Nebulised ketamine 1mg/kg
Other Name: S(+)-ketamine

Drug: Placebo first BA
Nebulised saline 1-2ml
Other Names:
  • NaCl
  • Saline

Active Comparator: Placebo first BA
Patients in this group will first receive physiological salt in the nebulised form form when they ask for pain relief. The second time they ask for pain relief, they will receive a dose of ketamine in the nebulised.
Drug: Ketamine first AB
Nebulised ketamine 1mg/kg
Other Name: S(+)-ketamine

Drug: Placebo first BA
Nebulised saline 1-2ml
Other Names:
  • NaCl
  • Saline




Primary Outcome Measures :
  1. Potential of S(+)-ketamine as an analgesic in the nebulised form [ Time Frame: 3 minutes ]
    TIme measured for the second request of analgesia. 3 minutes is the anticipated duration of analgesia achieved by nebulised s-ketamine.


Secondary Outcome Measures :
  1. Duration of analgesia [ Time Frame: 10 minutes ]
    Duration of analgesia will be assessed by pin prick and will be measured in minutes and stopped when the NRS to pin prick equals base level measurement.

  2. Duration of need for PACU care [ Time Frame: 3 hours ]
    When the patient is qualified for returning to the ward, the time is marked.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male
  • 18-65 years of age
  • PACU care after general anesthesia

Exclusion Criteria:

  • female
  • asthma
  • COPD
  • diabetes mellitus
  • unstable angina pectoris
  • high intracranial pressure
  • elevated intraocular pressure
  • neurosurgery
  • epidural or spinal analgesia
  • history of long-term pain state
  • poor co-operation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397356


Locations
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Finland
Tampere University Hospital
Tampere, Finland, 3351
Sponsors and Collaborators
Tampere University Hospital
Investigators
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Principal Investigator: Antti Kämäräinen, MD, PhD Pirkanmaa District Hospital, Department of Emergency Medicine

Publications:
Christensen K, Rogers E, Green GA, et al. Safety and efficacy of intranasal ketamine for acute postoperative pain. Acute Pain. 2007;9(4):183-192.
European Medicines Agency. Guideline for good clinical practice 2002. www.ema.com.eu. Accessed 8/1, 2012.

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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02397356     History of Changes
Other Study ID Numbers: R14066M
2014-000837-22 ( EudraCT Number )
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tampere University Hospital:
ketamine
Additional relevant MeSH terms:
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Ketamine
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action