Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy
Conditions
Keywords
pediatric pain, post operative pain, opioids, emergence agitation, preoperative anxiety, pharmacogenomics
Brief summary
The typical post-operative course for children following surgical removal of their tonsils and adenoids can be challenging, especially for pain control. First line medications for pain include intravenous and enteral narcotics, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) or N-methyl-D-aspartate (NMDA) antagonists but their effects appear to be short-lived. Gabapentin has been shown in adult studies to tone down the body's response to pain and decreases opioid use post-operatively. The purpose of this study is to see if a single preoperative dose will reduce post-operative pain scores and the amount of analgesic used.
Detailed description
This is a randomized, double blind, placebo-controlled trial to study the effect of a preoperative oral dose of gabapentin on postoperative analgesic requirements and subjective pain levels in children undergoing tonsillectomy with adenoidectomy. Investigators will also look for a limited set of genotypic variations to explain any difference between individuals or groups in their response to the medication. Additionally, investigators will document potential adverse effects including excessive sedation, respiratory issues, surgical bleeding and emergence agitation/delirium. Investigators hypothesize that gabapentin will reduce opioid analgesic requirements and pain scores up to 36 hours post adenotonsillectomy without increased adverse effects such as emergence delirium, respiratory complications or bleeding. The clinical effect may depend on the individual's pharmacogenetic profile to look for a specific set of genetic polymorphisms that relate to the metabolism and effect of the study drug, gabapentin, and opioid analgesic pain medications.
Interventions
DRUGGabapentin
The active comparator, Gabapentin, is a structural analog of g-aminobutyric acid which has anticonvulsant properties. This study is a prospective randomized double-blinded trial examining the effectiveness of a single dose of liquid Gabapentin given 60 minutes prior to surgery for pain management in pediatric tonsillectomy/adenoidectomy pediatric patients.
DRUGliquid placebo
Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* scheduled for outpatient tonsillectomy and adenoidectomy * \< 60 Kg, between 5th and 95th percentile for weight * ability to self-report pain * complete pain diary with assistance from parent or guardian
Exclusion criteria
* require pre-anesthesia medication for anxiety * require interpreter for verbal or written communication * Obstructive sleep apnea significant enough to not qualify for outpatient surgery per surgeon * ongoing oxygen dependence, pulmonary hypertension * elevated risk of regurgitation * history of seizures * currently taking psychoactive medications or having a psychiatric condition requiring medications * chronic pain disorders requiring medications * renal disease * developmental or cognitive disabilities * history of adverse reactions to components of liquid gabapentin or placebo
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Oral Analgesia Consumption | Up to 36 hours | Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-report Pain Score at Rest | Up to 36 hours | Self-report pain scores at rest, using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0.5 to 36 hours post op. |
| Self-report Pain Score When Swallowing | Up to 36 hours | Self-report pain scores when swallowing using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0 to 36 hours post op. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo group | 18 |
| Gabapentin Gabapentin | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Placebo | Total | Gabapentin |
|---|---|---|---|
| Age, Customized Median age (years) | 8.0 years | 8.0 years | 8.0 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 35 Participants | 18 Participants |
| Region of Enrollment United States | 18 participants | 36 participants | 18 participants |
| Sex: Female, Male Female | 12 Participants | 26 Participants | 14 Participants |
| Sex: Female, Male Male | 6 Participants | 10 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 3 / 18 | 9 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Total Oral Analgesia Consumption
Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively.
Time frame: Up to 36 hours
Population: Healthy children aged 5 - 16 years old.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 24h | 0.200 cumulative hydrocodone (mg/kg) | Standard Deviation 0.107 |
| Placebo Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 1h | 0.121 cumulative hydrocodone (mg/kg) | Standard Deviation 0.067 |
| Placebo Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 4h | 0.135 cumulative hydrocodone (mg/kg) | Standard Deviation 0.06 |
| Placebo Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 0.5h | 0.107 cumulative hydrocodone (mg/kg) | Standard Deviation 0.077 |
| Placebo Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 12h | 0.171 cumulative hydrocodone (mg/kg) | Standard Deviation 0.079 |
| Placebo Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 0h | 0.079 cumulative hydrocodone (mg/kg) | Standard Deviation 0.077 |
| Placebo Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 1.5h | 0.127 cumulative hydrocodone (mg/kg) | Standard Deviation 0.06 |
| Placebo Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 8h | 0.157 cumulative hydrocodone (mg/kg) | Standard Deviation 0.067 |
| Placebo Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 36h | 0.228 cumulative hydrocodone (mg/kg) | Standard Deviation 0.106 |
| Gabapentin Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 8h | 0.132 cumulative hydrocodone (mg/kg) | Standard Deviation 0.086 |
| Gabapentin Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 36h | 0.224 cumulative hydrocodone (mg/kg) | Standard Deviation 0.165 |
| Gabapentin Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 24h | 0.193 cumulative hydrocodone (mg/kg) | Standard Deviation 0.148 |
| Gabapentin Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 12h | 0.165 cumulative hydrocodone (mg/kg) | Standard Deviation 0.116 |
| Gabapentin Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 4h | 0.109 cumulative hydrocodone (mg/kg) | Standard Deviation 0.066 |
| Gabapentin Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 1.5h | 0.087 cumulative hydrocodone (mg/kg) | Standard Deviation 0.066 |
| Gabapentin Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 1h | 0.087 cumulative hydrocodone (mg/kg) | Standard Deviation 0.066 |
| Gabapentin Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 0.5h | 0.068 cumulative hydrocodone (mg/kg) | Standard Deviation 0.046 |
| Gabapentin Group | Total Oral Analgesia Consumption | cumulative hydrocodone (mg/kg) at 0h | 0.011 cumulative hydrocodone (mg/kg) | Standard Deviation 0.033 |
Secondary
Self-report Pain Score at Rest
Self-report pain scores at rest, using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0.5 to 36 hours post op.
Time frame: Up to 36 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Group | Self-report Pain Score at Rest | 0.5 hours | 5.33 score on a scale | Standard Deviation 2.94 |
| Placebo Group | Self-report Pain Score at Rest | 1.0 hours | 4.33 score on a scale | Standard Deviation 2.74 |
| Placebo Group | Self-report Pain Score at Rest | 1.5 hours | 4.00 score on a scale | Standard Deviation 2.45 |
| Placebo Group | Self-report Pain Score at Rest | 4 hours | 3.46 score on a scale | Standard Deviation 2.7 |
| Placebo Group | Self-report Pain Score at Rest | 8 hours | 3.91 score on a scale | Standard Deviation 2.57 |
| Placebo Group | Self-report Pain Score at Rest | 12 hours | 2.69 score on a scale | Standard Deviation 2.34 |
| Placebo Group | Self-report Pain Score at Rest | 24 hours | 3.04 score on a scale | Standard Deviation 2.32 |
| Placebo Group | Self-report Pain Score at Rest | 36 hours | 1.95 score on a scale | Standard Deviation 1.74 |
| Gabapentin Group | Self-report Pain Score at Rest | 36 hours | 4.00 score on a scale | Standard Deviation 1.07 |
| Gabapentin Group | Self-report Pain Score at Rest | 0.5 hours | 5.08 score on a scale | Standard Deviation 2.71 |
| Gabapentin Group | Self-report Pain Score at Rest | 8 hours | 2.71 score on a scale | Standard Deviation 1.93 |
| Gabapentin Group | Self-report Pain Score at Rest | 1.0 hours | 5.80 score on a scale | Standard Deviation 4.02 |
| Gabapentin Group | Self-report Pain Score at Rest | 24 hours | 4.61 score on a scale | Standard Deviation 2.96 |
| Gabapentin Group | Self-report Pain Score at Rest | 1.5 hours | 3.60 score on a scale | Standard Deviation 3.3 |
| Gabapentin Group | Self-report Pain Score at Rest | 12 hours | 4.20 score on a scale | Standard Deviation 2.35 |
| Gabapentin Group | Self-report Pain Score at Rest | 4 hours | 3.00 score on a scale | Standard Deviation 2.28 |
Secondary
Self-report Pain Score When Swallowing
Self-report pain scores when swallowing using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0 to 36 hours post op.
Time frame: Up to 36 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Group | Self-report Pain Score When Swallowing | 0.5 Hours | 6.47 score on a scale | Standard Deviation 3.16 |
| Placebo Group | Self-report Pain Score When Swallowing | 8 Hours | 5.30 score on a scale | Standard Deviation 2.67 |
| Placebo Group | Self-report Pain Score When Swallowing | 1.5 Hours | 5.40 score on a scale | Standard Deviation 3.71 |
| Placebo Group | Self-report Pain Score When Swallowing | 12 Hours | 3.86 score on a scale | Standard Deviation 2.27 |
| Placebo Group | Self-report Pain Score When Swallowing | 24 Hours | 5.46 score on a scale | Standard Deviation 2.88 |
| Placebo Group | Self-report Pain Score When Swallowing | 1 Hours | 4.78 score on a scale | Standard Deviation 2.95 |
| Placebo Group | Self-report Pain Score When Swallowing | 36 Hours | 3.70 score on a scale | Standard Deviation 2.41 |
| Placebo Group | Self-report Pain Score When Swallowing | 4 Hours | 4.30 score on a scale | Standard Deviation 1.64 |
| Gabapentin Group | Self-report Pain Score When Swallowing | 36 Hours | 5.13 score on a scale | Standard Deviation 2.47 |
| Gabapentin Group | Self-report Pain Score When Swallowing | 0.5 Hours | 5.42 score on a scale | Standard Deviation 3.37 |
| Gabapentin Group | Self-report Pain Score When Swallowing | 1 Hours | 6.00 score on a scale | Standard Deviation 3.65 |
| Gabapentin Group | Self-report Pain Score When Swallowing | 1.5 Hours | 5.50 score on a scale | Standard Deviation 2.99 |
| Gabapentin Group | Self-report Pain Score When Swallowing | 4 Hours | 4.27 score on a scale | Standard Deviation 3.44 |
| Gabapentin Group | Self-report Pain Score When Swallowing | 8 Hours | 4.00 score on a scale | Standard Deviation 2.18 |
| Gabapentin Group | Self-report Pain Score When Swallowing | 24 Hours | 5.65 score on a scale | Standard Deviation 3.64 |
| Gabapentin Group | Self-report Pain Score When Swallowing | 12 Hours | 4.80 score on a scale | Standard Deviation 2.86 |