Post-operative PainPhase 3NCT00624455
How Does Gabapentin Affects Post-operative Tonsillectomy Pain?
A Phase 3 study testing Gabapentin in people with Post-operative Pain, run by University of British Columbia at 1 site in Canada.
Trial summary
Gabapentin is a medicine that has been used in adults (but not yet in children) to treat pain after surgery. In children it has been used for many years to treat other conditions and has been shown to be very safe. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2007to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Tonsillectomy
- Adenotonsillectomy
- ASA status 1 to 3
- Weight < 60 kg
- BMI < 30
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Single Preoperative Dose of Gabapentin Reduce Postoperative Tonsillectomy Pain and Subsequent Morphine Requirement in Children?
Gabapentin is a medicine that has been used in adults (but not yet in children) to treat pain after surgery. In children it has been used for many years to treat other conditions and has been shown to be very safe.
Removal of tonsils is a common operation with each child experiencing a similar pattern of pain; this makes it good for looking at the effect of pain relieving medicines. In our study each child will get the same operation and medicines, as they would have normally. Before the operation and in a random way, half will get gabapentin and half will get the same syrup but with no gabapentin. Afterwards we will record how much pain the children have and how much of our standard medicine is needed to make them comfortable. We expect both of these results to be lower in the half who received gabapentin. We will also record the amount and type of unwanted effects, both from the gabapentin and from any other pain relief medicines.
Read the detailed description
Tonsillectomy is one of the most commonly performed children's surgeries and produces a consistent pattern and intensity of pain in the recovery period. These qualities make this surgery ideal for the investigation of pain relieving medications. Adequate analgesia for tonsillectomy in the perioperative period presents a challenge to the anesthetist because opiates, which provide the most effective analgesia, are associated with a high incidence of nausea and vomiting, respiratory depression, and sedation. These effects make recovery from tonsillectomy particularly hazardous in children with Obstructive Sleep Apnea Syndrome (OSAS) (the primary indication for tonsillectomy or adenotonsillectomy) thus alternatives to opiates have been sought. Gabapentin is a drug with an extensive safety record in the treatment of children's seizures, and chronic pain syndromes. Recently studies have demonstrated new modes of action for this medication, both directly on pain and in increasing the efficacy of conventional opiate (morphine) pain relieving medications. As such it may have role in the relief of acute pain. We hypothesize that given preoperatively as a single dose; gabapentin will reduce postoperative pain and opiate requirement in children undergoing tonsillectomy. Randomization will follow a computer generated random pattern with 14 patients in each group (placebo or gabapentin). Pain and sedation will be recorded as will the incidence of vomiting, dizziness and pruritis. Pain will be assessed using the Coloured Analogue Scale and sedation with the University of Michigan Sedation Scale. The time to first oral intake of fluids will also be recorded. All recordings will be made at 5-minute intervals from time of extubation (time = 0) and will be made by an independent blinded recovery nurse. Subjects will stay in the PACU for a minimum of one hour from time zero, and will only be discharged to the Surgical Daycare Unit at a point after this when two successive pain measurements demonstrate a score of 3 or less. In the Surgical Daycare Unit pain assessment will continue at intervals of 30 minutes to a total time of 4 hours from time zero and will be recorded by a member of the research team blinded to nature of premedication. A telephone interview will be scheduled with the subject's parents at 24 hours from time zero.
- Conditions
- Post-operative Pain
- Being tested
- Gabapentin, Placebo
- Keywords
- Gabapentin, tonsillectomy, post-operative pain, morphine requirements, randomized double blind, adenotonsillectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
One dose of oral premedication of Gabapentin 10 mg kg-1 given at least 30 but not more than 90 minutes before surgery. Max dose is 600mg.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | One dose of oral premedication of Gabapentin 10 mg kg-1 given at least 30 but not more than 90 minutes before surgery. Max dose is 600mg. Receives: Drug: Gabapentin |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative morphine consumption at four hours (from the time of extubation)
Measured: 4 hours
Secondary outcomes (1)
Pain scores, presence of nausea/ vomiting, dizziness, sedation, satisfaction
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionDec 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Robert Purdy, MD, Principal investigator, University of British ColumbiaMark Ansermino, MD, Study director, University of British ColumbiaAndrew Morrison, MD, Study director, University of British ColumbiaHelen Hume-Smith, MD, Study director, University of British ColumbiaSimon Whyte, MD, Study director, University of British ColumbiaCarolyne Montgomery, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624455
- Sponsor's protocol ID
- H07-00265
- Status last verified
- Aug 2009
- First submitted
- 18 Feb 2008
- Last updated
- 18 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Single Preoperative Dose of Gabapentin Reduce Postoperative Tonsillectomy Pain and Subsequent Morphine Requirement in Children?
- ClinicalTrials.gov ID
- NCT00624455
- Acronym / sponsor ID
- H07-00265
- Conditions
- Post-operative Pain
- Keywords
- Gabapentin, tonsillectomy, post-operative pain, morphine requirements, randomized double blind, adenotonsillectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gabapentin is a medicine that has been used in adults (but not yet in children) to treat pain after surgery. In children it has been used for many years to treat other conditions and has been shown to be very safe.
Removal of tonsils is a common operation with each child experiencing a similar pattern of pain; this makes it good for looking at the effect of pain relieving medicines. In our study each child will get the same operation and medicines, as they would have normally. Before the operation and in a random way, half will get gabapentin and half will get the same syrup but with no gabapentin. Afterwards we will record how much pain the children have and how much of our standard medicine is needed to make them comfortable. We expect both of these results to be lower in the half who received gabapentin. We will also record the amount and type of unwanted effects, both from the gabapentin and from any other pain relief medicines.
Detailed description
Tonsillectomy is one of the most commonly performed children's surgeries and produces a consistent pattern and intensity of pain in the recovery period. These qualities make this surgery ideal for the investigation of pain relieving medications. Adequate analgesia for tonsillectomy in the perioperative period presents a challenge to the anesthetist because opiates, which provide the most effective analgesia, are associated with a high incidence of nausea and vomiting, respiratory depression, and sedation. These effects make recovery from tonsillectomy particularly hazardous in children with Obstructive Sleep Apnea Syndrome (OSAS) (the primary indication for tonsillectomy or adenotonsillectomy) thus alternatives to opiates have been sought. Gabapentin is a drug with an extensive safety record in the treatment of children's seizures, and chronic pain syndromes. Recently studies have demonstrated new modes of action for this medication, both directly on pain and in increasing the efficacy of conventional opiate (morphine) pain relieving medications. As such it may have role in the relief of acute pain. We hypothesize that given preoperatively as a single dose; gabapentin will reduce postoperative pain and opiate requirement in children undergoing tonsillectomy. Randomization will follow a computer generated random pattern with 14 patients in each group (placebo or gabapentin). Pain and sedation will be recorded as will the incidence of vomiting, dizziness and pruritis. Pain will be assessed using the Coloured Analogue Scale and sedation with the University of Michigan Sedation Scale. The time to first oral intake of fluids will also be recorded. All recordings will be made at 5-minute intervals from time of extubation (time = 0) and will be made by an independent blinded recovery nurse. Subjects will stay in the PACU for a minimum of one hour from time zero, and will only be discharged to the Surgical Daycare Unit at a point after this when two successive pain measurements demonstrate a score of 3 or less. In the Surgical Daycare Unit pain assessment will continue at intervals of 30 minutes to a total time of 4 hours from time zero and will be recorded by a member of the research team blinded to nature of premedication. A telephone interview will be scheduled with the subject's parents at 24 hours from time zero.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: GabapentinOne dose of oral premedication of Gabapentin 10 mg kg-1 given at least 30 but not more than 90 minutes before surgery. Max dose is 600mg. |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Tonsillectomy
- Adenotonsillectomy
- ASA status 1 to 3
- Weight < 60 kg
- BMI < 30
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinOne dose of oral premedication of Gabapentin 10 mg kg-1 given at least 30 but not more than 90 minutes before surgery. Max dose is 600mg. | Drug | 1 |
| PlaceboPlacebo | Drug | 2 |
Primary outcome
Total postoperative morphine consumption at four hours (from the time of extubation)
Time frame: 4 hours
1 secondary outcome
Pain scores, presence of nausea/ vomiting, dizziness, sedation, satisfaction
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Purdy, MD principal investigator
University of British Columbia
Mark Ansermino, MD study director
University of British Columbia
Andrew Morrison, MD study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin in people with Post-operative Pain, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total postoperative morphine consumption at four hours (from the time of extubation) (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2009.