Postoperative Pain
Conditions
Keywords
Gabapentin, Pediatric Spinal Fusion, Narcotic Use
Brief 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. 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
Interventions
DRUGGabapentin
oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge
DRUGPlacebo
DRUGMorphine
Administered as needed
Sponsors
Children's Hospital and Health System Foundation, Wisconsin
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* ASA 1-2, Idiopathic Scoliosis
Exclusion criteria
* ASA 3 or greater * Neuromuscular scoliosis * On narcotics baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Morphine Consumed (mg/kg/hr) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Ondansetron Doses Administered for Nausea | First 10 days after surgery | The number of doses of Ondansetron given for nausea to participants in both groups. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin/Morphine Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. \*Both groups received Morphine as needed. | 32 |
| Placebo/Morphine Placebo Comparator - group received placebo 3 times daily. \*Both groups received Morphine as needed. | 31 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Gabapentin/Morphine | Placebo/Morphine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 32 Participants | 31 Participants | 63 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.8 years STANDARD_DEVIATION 2.1 | 14.2 years STANDARD_DEVIATION 1.8 | 14.5 years STANDARD_DEVIATION 2 |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 |
Outcome results
Primary
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.
Time frame: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin/Morphine | Amount of Morphine Consumed (mg/kg/hr) | 0.064 mg/kg/h | Standard Deviation 0.031 |
| Placebo/Morphine | Amount of Morphine Consumed (mg/kg/hr) | 0.044 mg/kg/h | Standard Deviation 0.017 |
Primary
Amount of Morphine Consumed (mg/kg/hr)
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin/Morphine | Amount of Morphine Consumed (mg/kg/hr) | 0.055 mg/kg/h | Standard Deviation 0.017 |
| Placebo/Morphine | Amount of Morphine Consumed (mg/kg/hr) | 0.046 mg/kg/h | Standard Deviation 0.016 |
Primary
Amount of Morphine Consumed (mg/kg/hr)
Time frame: Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin/Morphine | Amount of Morphine Consumed (mg/kg/hr) | 0.047 mg/kg/h | Standard Deviation 0.019 |
| Placebo/Morphine | Amount of Morphine Consumed (mg/kg/hr) | 0.036 mg/kg/h | Standard Deviation 0.016 |
Secondary
Number of Ondansetron Doses Administered for Nausea
The number of doses of Ondansetron given for nausea to participants in both groups.
Time frame: First 10 days after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gabapentin/Morphine | Number of Ondansetron Doses Administered for Nausea | 2.0 doses of medication administered |
| Placebo/Morphine | Number of Ondansetron Doses Administered for Nausea | 2.0 doses of medication administered |