Postoperative PainNCT00726999
Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion
A study testing Gabapentin and Morphine in people with Postoperative Pain, run by Medical College of Wisconsin.
Trial summary
Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine and placebo group with similar pills, also PCA morphine. Read more about this study
- Who is it for?
- Ages 9 to 18 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Gabapentin and Morphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to May 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 9 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA 1-2, Idiopathic Scoliosis
Who cannot join
- ASA 3 or greater
- Neuromuscular scoliosis
- On narcotics baseline
About this study
Official title: Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients
Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine and placebo group with similar pills, also PCA morphine. The goal is to measure morphine usage and incidence of morphine side effects (pruritis, days foley, days to first stool, sedation, pain scores, PCA use).
Read the detailed description
Healthy, American Society of Anesthesia (ASA) 1-2 Idiopathic Scoliosis patients for spinal fusion.
Blinded, drug only known by hospital pharmacist. Study group 1- Gabapentin 15mg/kg with premed, 5/kg TID for 5 days of discharge, standard PCA morphine with dose and basal Study Group 2- Capsules resembling neurontin, with standard PCA morphine
No remifentanil, clonidine, ketamine
N=60 First patient enrolled 6/06 Last patient enrolled 7/15/08
- Conditions
- Postoperative Pain
- Being tested
- Gabapentin, Placebo, Morphine
- Keywords
- Gabapentin, Pediatric Spinal Fusion, Narcotic Use
- 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
Also called Neurontin
oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge
PlaceboDrug
MorphineDrug
Administered as needed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Gabapentin Receives: Drug: Gabapentin; Drug: Morphine |
| 2 | Placebo comparator | Placebo Comparator -- pill matched in appearance to gabapentin Receives: Drug: Placebo; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Morphine Consumed (mg/kg/hr)
Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.
Measured: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)
Amount of Morphine Consumed (mg/kg/hr)
Measured: Day 1
Amount of Morphine Consumed (mg/kg/hr)
Measured: Day 2
Secondary outcomes (1)
Number of Ondansetron Doses Administered for Nausea
The number of doses of Ondansetron given for nausea to participants in both groups.
Measured: First 10 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJun 2006
- Primary completionJul 2008
- Study completionMay 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Responsible party
- Principal investigator, Lynn Rusy, Medical College of Wisconsin
- Investigators
- Lynn M Rusy, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726999
- Sponsor's protocol ID
- 06/71,GC 138
- Status last verified
- Mar 2019
- First submitted
- 30 Jul 2008
- Last updated
- 3 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients
- ClinicalTrials.gov ID
- NCT00726999
- Acronym / sponsor ID
- 06/71,GC 138
- Conditions
- Postoperative Pain
- Keywords
- Gabapentin, Pediatric Spinal Fusion, Narcotic Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin
- Study start
- Jun 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Posted 30 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine and placebo group with similar pills, also PCA morphine. The goal is to measure morphine usage and incidence of morphine side effects (pruritis, days foley, days to first stool, sedation, pain scores, PCA use).
Detailed description
Healthy, American Society of Anesthesia (ASA) 1-2 Idiopathic Scoliosis patients for spinal fusion.
Blinded, drug only known by hospital pharmacist. Study group 1- Gabapentin 15mg/kg with premed, 5/kg TID for 5 days of discharge, standard PCA morphine with dose and basal Study Group 2- Capsules resembling neurontin, with standard PCA morphine
No remifentanil, clonidine, ketamine
N=60 First patient enrolled 6/06 Last patient enrolled 7/15/08
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Gabapentin, Drug: MorphineGabapentin |
| 2 | Placebo comparator | Drug: Placebo, Drug: MorphinePlacebo Comparator -- pill matched in appearance to gabapentin |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- ASA 1-2, Idiopathic Scoliosis
Key exclusion criteria (3 listed)
- ASA 3 or greater
- Neuromuscular scoliosis
- On narcotics baseline
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 |
|---|---|---|
| GabapentinAlso: Neurontinoral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge | Drug | 1 |
| Placebo | Drug | 2 |
| MorphineAdministered as needed | Drug | 1, 2 |
Primary outcome
Amount of Morphine Consumed (mg/kg/hr)
Time frame: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)
Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour.
Amount of Morphine Consumed (mg/kg/hr)
Time frame: Day 1
Amount of Morphine Consumed (mg/kg/hr)
Time frame: Day 2
1 secondary outcome
Number of Ondansetron Doses Administered for Nausea
Time frame: First 10 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- 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.
Lynn M Rusy, MD principal investigator
Medical College of Wisconsin
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin and Morphine in people with Postoperative Pain, run by Medical College of Wisconsin.
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 1 inclusion and 3 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 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 30 Dec 2010). 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?
Amount of Morphine Consumed (mg/kg/hr) (time frame: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)). The study lists 3 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 3 Apr 2019.