Pediatric Ketamine Study for Pain Management
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| ClinicalTrials.gov Identifier: NCT02388321 |
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Recruitment Status :
Terminated
(Patients meeting inclusion criteria was low, and PI went to another institution.)
First Posted : March 17, 2015
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain | Drug: Ketamine Drug: Fentanyl | Phase 4 |
Intranasal (IN) delivery of analgesic agents provides rapid and convenient drug administration without the need for needles. In children, the placement of an intravenous line often increases anxiety and pain, requires nursing time, and can be very difficult to achieve, so the IN route is particularly advantageous. IN delivery of fentanyl has become increasingly more common in pain management for children in many settings, including pre-hospital and emergency department (ED) settings. Over the past decade, many studies have demonstrated that intranasal fentanyl is as effective as intravenous morphine to treat acute moderate to severe pain. Intranasal fentanyl has become standard of care in some pediatric EDs with the advantage of avoiding intravenous line placement. However, adverse effects attributed to IN fentanyl are similar to those of other opioid analgesics: hypotension, sedation, and occasionally respiratory depression. Ketamine is a noncompetitive N-methyl D-aspartate (NMDA) receptor antagonist that blocks the release of the excitatory neurotransmitter glutamate and provides anesthesia, amnesia, and analgesia by decreasing central sensitization and "wind-up" phenomenon. Due to its high lipid solubility, ketamine rapidly crosses the blood-brain barrier, provides rapid onset of action (peak concentration at 1 minute after intravenous push) and rapid recovery to baseline (duration of action 5-15 minutes after intravenous push). At sub-dissociative doses, either used as an adjunct to opioid analgesics or as a solo agent, ketamine provides effective analgesia while preserving airway patency, ventilation, and cardiovascular stability.
Ketamine has been less studied for pain management, however it has been safely used via different routes of administration in children. Studies dating back to 1990's use ketamine at doses as high as 6 mg/kg intranasally in children for pre-medication prior to surgery or for sedation with little or no reported adverse effects. A hospital in Australia is currently conducting a clinical trial comparing IN fentanyl 1.5 ug/kg to IN ketamine 1mg/kg for the treatment of pain caused by isolated musculoskeletal injury. The intention of our study is similar to this, however the investigators will not limit the patients to those with only musculoskeletal pain and a more simplified pain scale will be used.
To assess pain, the investigators will use the standard pain scale that is currently used in our Pediatric ED in order to minimize the need to re-train any of our staff with a different pain scale. The scale incorporates the Numerical rating scale (0-10 scale; NRS) and the Wong-Baker faces pain scale (6 faces corresponding to 0,2,4,6,8,10; WBS). While prior studies have used different pain scales, primarily the visual analog scale (VAS), the scales that the investigator currently use have been validated in children in 2009.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 22 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison of Sub-dissociative Dose Intranasal Ketamine to Intranasal Fentanyl for Treatment of Moderate to Severe Pain in Pediatric Patients Presenting to the Emergency Department: a Prospective, Randomized, Double-blind Study |
| Actual Study Start Date : | May 1, 2015 |
| Actual Primary Completion Date : | December 31, 2016 |
| Actual Study Completion Date : | October 14, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ketamine
intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
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Drug: Ketamine
intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department. |
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Active Comparator: Fentanyl
intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
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Drug: Fentanyl
intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
Other Name: Fetanyl |
- Pain Score at 30 Minutes [ Time Frame: 30 minutes ]An 11 point Likert Visual Analog Scale with 0 being no pain, 5 being moderate pain and 10 being very severe pain was verbally administered to the patient at 30 minutes post administration of analgesia.
- Adverse Events at 30 Minutes [ Time Frame: 30 minutes ]The patient were asked at 30 minutes post administration of analgesia if they experienced any side effects like nausea, vomiting, headache etc.
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| Ages Eligible for Study: | 3 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children aged 3-17,
- weighing less than 50kg
- present to the pediatric ED with moderate-severe acute pain (defined as pain greater than or equal to 6/10).
- Treating physician determines the patient to require opioid analgesia.
Exclusion Criteria:
- Children with facial trauma or any abnormal nasal anatomy;
- developmentally delayed children;
- children with head trauma/increased intracranial pressure (ICP);
- children with known allergy to fentanyl or ketamine;
- children who are unable to provide pain scale assessment;
- children with chronic pain of greater than 4 weeks;
- Pregnant females;
- and children with a Glasgow Coma Scale (GCS)<15.
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): NCT02388321
| United States, New York | |
| Maimonides Medical Center | |
| Brooklyn, New York, United States, 11219 | |
| Principal Investigator: | Sabina Zavolkovskaya, MD | Maimonides Medical Center | |
| Study Director: | Sergey Motov, MD | Maimonides Medical Center | |
| Study Chair: | John Marshall, MD | Maimonides Medical Center |
| Responsible Party: | Antonios Likourezos, Research Manager, Maimonides Medical Center |
| ClinicalTrials.gov Identifier: | NCT02388321 |
| Other Study ID Numbers: |
2014-11-20-MMC |
| First Posted: | March 17, 2015 Key Record Dates |
| Results First Posted: | May 8, 2018 |
| Last Update Posted: | May 8, 2018 |
| Last Verified: | October 2017 |
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Analgesia pediatrics pain management |
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Fentanyl Ketamine 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 Analgesics, Opioid Narcotics Adjuvants, Anesthesia |