Postoperative PainNCT00793910
Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy
A study testing Gabapentin in people with Postoperative Pain, run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of an oral medication called gabapentin in reducing pain after Photorefractive Keratectomy (PRK) eye surgery and to assess the frequency of use of rescue medication interventions, defined as non-steroidal anti-inflammatory (NSAID) eye drops and oral narcotic… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative 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
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to understand and provide informed consent to participate in this study and complete follow-up visits.
- Planned Photorefractive keratectomy (PRK) at the WRAMC Center for Refractive Surgery.
- Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- Access to transportation to meet follow-up requirements.
Who cannot join
- Any reason to be excluded for PRK.
- Female subjects who are pregnant, breast feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not].
- Patients with known allergy, sensitivity or inappropriate responsiveness to Gabapentin or any of the medications used in the post-operative course.
- Patients with known depressed renal function.
- Any physical or mental impairment that would preclude participation in any of the examinations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
Official title: Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy: A Randomized, Double-masked, Single Center, Placebo-controlled Clinical Trial
The purpose of this study is to determine the effectiveness of an oral medication called gabapentin in reducing pain after Photorefractive Keratectomy (PRK) eye surgery and to assess the frequency of use of rescue medication interventions, defined as non-steroidal anti-inflammatory (NSAID) eye drops and oral narcotic medication.
- Conditions
- Postoperative Pain
- Being tested
- Gabapentin, placebo
- Keywords
- Gabapentin, PRK, pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Gabapentin 300 mg taken by mouth thrice daily for 7 days
placeboDrug
placebo (sugar pill) taken by mouth thrice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | oral medication Receives: Drug: Gabapentin |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Pain
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Measured: 2 hours postoperatively
Level of Pain
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Measured: day 1 postoperatively
Level of Pain
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Measured: 3 days postoperatively
Level of Pain
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Measured: 4 days postoperatively
Secondary outcomes (1)
Occurence of Use of Rescue Medication
Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured
Measured: 2 hours to 4 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Samantha B. Rodgers, MD, Fort Belvoir Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793910
- Sponsor's protocol ID
- WRAMC WU# 08-6960
- Status last verified
- Jul 2014
- First submitted
- 18 Nov 2008
- Last updated
- 16 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy: A Randomized, Double-masked, Single Center, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00793910
- Acronym / sponsor ID
- WRAMC WU# 08-6960
- Conditions
- Postoperative Pain
- Keywords
- Gabapentin, PRK, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Posted 7 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of an oral medication called gabapentin in reducing pain after Photorefractive Keratectomy (PRK) eye surgery and to assess the frequency of use of rescue medication interventions, defined as non-steroidal anti-inflammatory (NSAID) eye drops and oral narcotic medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: Gabapentinoral medication |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to understand and provide informed consent to participate in this study and complete follow-up visits.
- Planned Photorefractive keratectomy (PRK) at the WRAMC Center for Refractive Surgery.
- Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- Access to transportation to meet follow-up requirements.
Key exclusion criteria (5 listed)
- Any reason to be excluded for PRK.
- Female subjects who are pregnant, breast feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not].
- Patients with known allergy, sensitivity or inappropriate responsiveness to Gabapentin or any of the medications used in the post-operative course.
- Patients with known depressed renal function.
- Any physical or mental impairment that would preclude participation in any of the examinations.
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 |
|---|---|---|
| GabapentinGabapentin 300 mg taken by mouth thrice daily for 7 days | Drug | Gabapentin |
| placeboplacebo (sugar pill) taken by mouth thrice daily for 7 days | Drug | placebo |
Primary outcome
Level of Pain
Time frame: 2 hours postoperatively
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Level of Pain
Time frame: day 1 postoperatively
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Level of Pain
Time frame: 3 days postoperatively
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
Level of Pain
Time frame: 4 days postoperatively
level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain)
1 secondary outcome
Occurence of Use of Rescue Medication
Time frame: 2 hours to 4 days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin in people with Postoperative Pain, run by Walter Reed Army Medical Center at 1 site in United States.
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 4 inclusion and 5 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 16 Jul 2014. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Level of Pain (time frame: 2 hours postoperatively). The study lists 4 primary outcomes in all. 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 16 Jul 2014.