An interventional study of Gabapentin and liquid placebo in Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 5 Years to 16 Years. Per ClinicalTrials.gov, last updated 2021-01-15.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 36 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
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Exclusion Criteria:
gabapentin, 20 mg/kg, single dose, 60 min prior to surgery
Drug: Gabapentin
subjects randomized to the liquid placebo arm will receive a single dose elixir of 0.4 mL/kg given 60 min prior to surgery
Drug: liquid placebo
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.
Also known as: Neurontin
Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg.
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
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
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
| Milestone | Placebo Group | Gabapentin Group |
|---|---|---|
| Started | 18 | 18 |
| Completed | 18 | 18 |
| Not completed | 0 | 0 |
Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively.
| cumulative hydrocodone (mg/kg) | Placebo Group | Gabapentin Group |
|---|---|---|
| cumulative hydrocodone (mg/kg) at 36h | 0.228 ± 0.106 | 0.224 ± 0.165 |
| cumulative hydrocodone (mg/kg) at 24h | 0.200 ± 0.107 | 0.193 ± 0.148 |
| cumulative hydrocodone (mg/kg) at 12h | 0.171 ± 0.079 | 0.165 ± 0.116 |
| cumulative hydrocodone (mg/kg) at 8h | 0.157 ± 0.067 | 0.132 ± 0.086 |
| cumulative hydrocodone (mg/kg) at 4h | 0.135 ± 0.060 | 0.109 ± 0.066 |
| cumulative hydrocodone (mg/kg) at 1.5h | 0.127 ± 0.060 | 0.087 ± 0.066 |
| cumulative hydrocodone (mg/kg) at 1h | 0.121 ± 0.067 | 0.087 ± 0.066 |
| cumulative hydrocodone (mg/kg) at 0.5h | 0.107 ± 0.077 | 0.068 ± 0.046 |
| cumulative hydrocodone (mg/kg) at 0h | 0.079 ± 0.077 | 0.011 ± 0.033 |
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.
| score on a scale | Gabapentin Group | Placebo Group |
|---|---|---|
| 0.5 hours | 5.33 ± 2.94 | 5.08 ± 2.71 |
| 1.0 hours | 4.33 ± 2.74 | 5.80 ± 4.02 |
| 1.5 hours | 4.00 ± 2.45 | 3.60 ± 3.30 |
| 4 hours | 3.46 ± 2.70 | 3.00 ± 2.28 |
| 8 hours | 3.91 ± 2.57 | 2.71 ± 1.93 |
| 12 hours | 2.69 ± 2.34 | 4.20 ± 2.35 |
| 24 hours | 3.04 ± 2.32 | 4.61 ± 2.96 |
| 36 hours | 1.95 ± 1.74 | 4.00 ± 1.07 |
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.
| score on a scale | Gabapentin Group | Placebo Group |
|---|---|---|
| 0.5 Hours | 6.47 ± 3.16 | 5.42 ± 3.37 |
| 1 Hours | 4.78 ± 2.95 | 6.00 ± 3.65 |
| 1.5 Hours | 5.40 ± 3.71 | 5.50 ± 2.99 |
| 4 Hours | 4.30 ± 1.64 | 4.27 ± 3.44 |
| 8 Hours | 5.30 ± 2.67 | 4.00 ± 2.18 |
| 12 Hours | 3.86 ± 2.27 | 4.80 ± 2.86 |
| 24 Hours | 5.46 ± 2.88 | 5.65 ± 3.64 |
| 36 Hours | 3.70 ± 2.41 | 5.13 ± 2.47 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/18 (0%) | 0/18 (0%) | 3/18 (16.7%) |
| Gabapentin | 0/18 (0%) | 0/18 (0%) | 9/18 (50%) |
| Event | Placebo | Gabapentin |
|---|---|---|
| Unplanned admission post tonsillectomySurgical and medical procedures | 1/18 | 7/18 |
| DizzinessNervous system disorders | 0/18 | 2/18 |
| NauseaGastrointestinal disorders | 2/18 | 2/18 |
| Age, Customized(years) | Placebo | Gabapentin | Total |
|---|---|---|---|
| Median age (years) | 8.0 (5 to 14) | 8.0 (5 to 15) | 8.0 (5 to 15) |
| Sex: Female, Male(Participants) | Placebo | Gabapentin | Total |
|---|---|---|---|
| Female | 12 | 14 | 26 |
| Male | 6 | 4 | 10 |
| Race (NIH/OMB)(Participants) | Placebo | Gabapentin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 17 | 18 | 35 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | Gabapentin | Total |
|---|---|---|---|
| United States | 18 | 18 | 36 |
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University of Colorado, Denver