Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents
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| ClinicalTrials.gov Identifier: NCT00312260 |
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Recruitment Status :
Completed
First Posted : April 7, 2006
Last Update Posted : October 20, 2020
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Sponsor:
The Hospital for Sick Children
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Stephen Brown, The Hospital for Sick Children
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Brief Summary:
The objective of the study is to compare the efficacy of gabapentin and amitriptyline for treating neuropathic pain in children in a randomized controlled trial.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain | Drug: Gabapentin Drug: Amitriptyline | Phase 3 |
Clinical experience and case reports suggest that both amitriptyline and gabapentin are effective treatments for neuropathic pain in children; however we do not know which drug is more effective for specific pain conditions or for specific children. This study will be the first prospective, randomized double-blind controlled trial directly comparing gabapentin and amitriptyline for the treatment of neuropathic pain in a paediatric population. We will also study the time course for pain reduction and evaluate changes in children's physical function, mood, and sleep. This information is needed to determine which drug is better for which children and which pain conditions.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 34 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Controlled Trial Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents |
| Study Start Date : | April 2006 |
| Actual Primary Completion Date : | May 2010 |
| Actual Study Completion Date : | March 2, 2017 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: Gabapentin
Gabapentin will be prescribed at 900mg/d (300mg tid). A dose escalation schedule will be followed: one pill taken at night (~2000h) for the first 3 days, one pill at night and one pill in the morning (~0800h) for the second 3 days and finally, one pill at night, one in the morning and one mid-afternoon (~1400h) for the reminder of the trial. |
| Active Comparator: 2 |
Drug: Amitriptyline
Amitriptyline will be prescribed at a dose of 10mg (qhs). A dose escalation schedule will be followed: one pill taken at night (~2000h) for the first 3 days, one pill at night and one pill in the morning (~0800h) for the second 3 days and finally, one pill at night, one in the morning and one mid-afternoon (~1400h) for the reminder of the trial. |
Primary Outcome Measures :
- change in child's pain intensity score [ Time Frame: 6 weeks ]
Secondary Outcome Measures :
- change in child's pain-related disability ratings [ Time Frame: 6 weeks ]
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| Ages Eligible for Study: | 8 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 8 - 17 years of age
- Diagnosis of neuropathic pain
Exclusion Criteria:
- Additional health problems
- Lactose intolerant
- Unable to swallow size 0 gelatin capsules
- Pregnant
- Unable to speak English
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): NCT00312260
Locations
| Canada, Ontario | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Investigators
| Principal Investigator: | Stephen Brown, MD | The Hospital for Sick Children, Toronto Canada |
| Responsible Party: | Stephen Brown, Staff Anesthesiologist, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT00312260 |
| Other Study ID Numbers: |
1000008259 |
| First Posted: | April 7, 2006 Key Record Dates |
| Last Update Posted: | October 20, 2020 |
| Last Verified: | October 2020 |
Keywords provided by Stephen Brown, The Hospital for Sick Children:
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Pain Analgesia Gabapentin Amitriptyline Pediatrics |
Additional relevant MeSH terms:
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Amitriptyline Amitriptyline, perphenazine drug combination Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Anti-Anxiety Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antimanic Agents Antidepressive Agents, Tricyclic Antidepressive Agents Analgesics, Non-Narcotic Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Adrenergic Agents |