Gabapentin for Postoperative Pain in Children

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of California, Davis

Must not be taking: Opioids

Disqualifiers: Renal failure, Seizures, Chronic pain, Autism, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether gabapentin can reduce the need for strong painkillers, like morphine, in children after chest surgery. Researchers compare gabapentin to a placebo (a non-active treatment) to determine its effectiveness in lessening pain without relying on narcotics. Children who have undergone chest surgery and expect to stay in the hospital for at least two days might be suitable for this study. The goal is to find safer ways to manage pain in children after surgery. As a Phase 2/3 trial, this research measures gabapentin's effectiveness in an initial group and represents the final step before FDA approval, offering a chance to contribute to safer pain management for children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used opioids in the last 30 days or if you have a history of seizures requiring treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that gabapentin is generally safe for children when used to manage pain. In past studies, gabapentin reduced the need for pain medicine after surgery, leading to less use of strong painkillers like opioids. Some common side effects, such as anxiety and nausea, were reported, but they occurred infrequently. Overall, children tolerate the treatment well. Gabapentin has proven safe in various situations, but its effectiveness can depend on the type of pain being treated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for postoperative pain?

Gabapentin is unique for postoperative pain management in children because it targets neuropathic pain pathways that typical treatments, like opioids and acetaminophen, do not specifically address. Unlike standard options, gabapentin can reduce the need for opioids, which are associated with higher risks of side effects and dependency. Researchers are excited because gabapentin offers a potentially safer and more effective way to manage pain without the complications of traditional painkillers.

What evidence suggests that gabapentin might be an effective treatment for postoperative pain in children?

Research has shown that gabapentin can reduce pain and the need for strong painkillers, like opioids, after surgery in children. In several studies, children who took gabapentin after surgery required fewer opioids and experienced less pain compared to those who did not take it. One study found that children taking gabapentin needed strong painkillers for almost a full day less after surgery. Another study demonstrated that taking gabapentin for three days significantly lowered pain levels. In this trial, some participants will receive gabapentin to evaluate its effectiveness in managing postoperative pain, while others will receive a placebo for comparison. These findings suggest gabapentin may help manage pain and reduce the need for stronger pain medications in children after surgery. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children from newborns up to under 18 years old who are undergoing thoracic surgery and will stay in the hospital for at least 48 hours. They must be born after a full-term pregnancy (at least 38 weeks). Children with autism, kidney failure, current participation in another study, opioid use within the last month, chronic pain treatment, active seizure disorders or those unable to take oral medication cannot join.

Inclusion Criteria

I am scheduled for a chest surgery that is not related to my heart.

I am under 18 years old.

I have had surgery in my chest area.

Exclusion Criteria

Pregnancy

I have used opioids in the last 30 days.

Participation in another clinical study presently or within the last 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive gabapentin or placebo perioperatively and postoperatively to assess its impact on opioid use and pain management

7 days

Daily monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on opioid use, pain scores, and potential adverse effects

7 days post-operative or until discharge

What Are the Treatments Tested in This Trial?

Interventions

• Gabapentin
• Placebo

Trial Overview The trial is testing whether gabapentin can reduce the need for opioid painkillers after thoracic surgery in children. Participants will either receive gabapentin or a placebo during and after their operation to compare how much narcotic medication they'll need post-surgery.

How Is the Trial Designed?

Group I: Gabapentin Treatment Active Control 1 Intervention

Given at a dose of 10mg/kg (max 600mg) perioperatively (immediately prior to surgery) followed by 3mg/kg/dose TID with first dose to be given starting at 8 hours post perioperative dose.

Group II: Control Group Placebo Group 1 Intervention

Given placebo which coincides with the active treatment group

Gabapentin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Neurontin for:

• Postherpetic neuralgia
• Partial-onset seizures

Approved in European Union as Gabapentin for:

• Peripheral neuropathic pain
• Partial-onset seizures

Approved in Canada as Gabapentin for:

• Postherpetic neuralgia
• Partial-onset seizures

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

The GAP study is a multicentre, double-blind, randomized controlled trial designed to evaluate the effectiveness and safety of gabapentin as an adjunct to standard pain management in patients undergoing major surgery, involving patients aged 18 and over.

The primary outcome of the study is the length of hospital stay after surgery, with secondary outcomes including pain levels, opioid use, adverse events, and quality of life, providing a comprehensive assessment of gabapentin's impact on postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study). Baos, S., Rogers, CA., Abbadi, R., et al.[2021]

Gabapentin, administered at 10 mg/kg before surgery, significantly reduced postoperative pain intensity in children undergoing unilateral limb surgery, particularly noted at 4 and 8 hours post-surgery.

The use of gabapentin also led to increased sedation during the operation, reduced postoperative agitation, and lessened the hemodynamic response during intubation, indicating its potential benefits in pediatric anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Gabapentin on Postoperative Pain of Orthopedic Surgery of Lower Limb by Sciatic and Femoral Blockage in Children: A Clinical Trial. Pinto Filho, WA., Silveira, LHJ., Vale, ML., et al.[2022]

In a study of outpatient orthopedic surgery patients, the addition of gabapentin to a post-operative pain management plan significantly reduced the percentage of patients requesting narcotic refills from 22.8% to 9.0% within three weeks after surgery (P = 0.006).

Despite the reduction in narcotic use, gabapentin did not negatively impact pain control, as measured by Visual Analogue Scale and Single Assessment Numerical Evaluation scores, indicating it can be safely integrated into post-operative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the addition of post-operative gabapentin reduce the use of narcotics after orthopedic surgery? Giakas, JA., Israel, HA., Ali, AH., et al.[2023]

Gabapentin significantly reduced the amount of postoperative opioids needed by children undergoing appendectomy, with the gabapentin group requiring only 0.034 mg morphine equivalents/kg compared to 0.106 mg in the non-gabapentin group.

Despite the reduction in opioid use, gabapentin did not lead to differences in pain scores or rates of emergency department revisits and readmissions, indicating it may be a safe option for postoperative pain management in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of gabapentin as a postoperative analgesic in children undergoing appendectomy. Baxter, KJ., Hafling, J., Sterner, J., et al.[2020]

A meta-analysis of 9 randomized controlled trials found that preoperative gabapentin significantly reduces both acute and chronic postoperative pain following breast cancer surgery, as measured by visual analog scale (VAS) scores.

Gabapentin also decreases total morphine consumption and the incidence of nausea after surgery, suggesting it can enhance pain management and reduce opioid use in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of gabapentin in reducing pain intensity and morphine consumption after breast cancer surgery: A meta-analysis. Jiang, Y., Li, J., Lin, H., et al.[2022]

Gabapentin 250 mg was found to be statistically more effective than placebo in providing at least 50% pain relief in established acute postoperative pain, with a relative benefit of 2.5 and a number-needed-to-treat of 11.

Despite showing some efficacy, gabapentin's clinical value as a standalone treatment for acute postoperative pain is limited compared to commonly used analgesics, and it was associated with similar rates of adverse events as placebo, with no serious side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single dose oral gabapentin for established acute postoperative pain in adults. Straube, S., Derry, S., Moore, RA., et al.[2023]

A systematic review of studies on nonopioid analgesics for pediatric postoperative pain found that medications like acetaminophen, NSAIDs, dexamethasone, ketamine, clonidine, and dexmedetomidine can help reduce pain and lower opioid use in children after surgery.

However, the evidence is limited, and there is a lack of studies on other potential nonopioid treatments like gabapentin and magnesium, indicating a need for more research to better understand their effectiveness in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for the Efficacy of Systemic Opioid-Sparing Analgesics in Pediatric Surgical Populations: A Systematic Review. Zhu, A., Benzon, HA., Anderson, TA.[2022]

In a study of 29,467 children undergoing appendectomy for perforated appendicitis, those who received gabapentin showed a significant reduction in postoperative opioid use, with 0.65 fewer days of opioid consumption compared to those who did not receive it.

Gabapentin administration was also associated with a shorter hospital stay, averaging 0.69 fewer days, suggesting it may be an effective part of multimodal pain management strategies in pediatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gabapentin is Associated With Decreased Postoperative Opioid Use and Length of Stay After Appendectomy in Children With Perforated Appendicitis: A Propensity Score-Matched Analysis. Lascano, D., Zamora, AK., Mahdi, E., et al.[2023]

In two randomized controlled trials involving patients undergoing total hip or knee arthroplasty, the addition of gabapentin to a multimodal pain management regimen did not significantly reduce morphine consumption compared to a control group, with a mean effect size estimate of 1.0 (P=0.73).

The findings suggest that gabapentin may not be an effective strategy for improving postoperative pain management in total joint replacement surgeries, highlighting the need for further research to enhance pain relief for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reanalysis of morphine consumption from two randomized controlled trials of gabapentin using longitudinal statistical methods. Zhang, S., Paul, J., Nantha-Aree, M., et al.[2022]

The GAPP-2 study is a randomized, double-blind, placebo-controlled trial involving 66 children aged 3 months to 18 years, aimed at evaluating the efficacy and safety of gabapentin as an add-on to morphine for treating severe chronic neuropathic or mixed pain over a 12-week period.

The primary goal is to determine if gabapentin can significantly reduce pain scores compared to placebo, potentially leading to better pain management strategies for children, while also confirming the appropriate pediatric dosing for gabapentin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial. de Leeuw, TG., Mangiarini, L., Lundin, R., et al.[2020]

In a study of 120 children undergoing adenotonsillectomy, the combination of gabapentin and dexamethasone significantly reduced post-operative pain scores compared to a placebo, especially at 4, 6, and 8 hours after surgery.

The use of gabapentin premedication with dexamethasone not only prolonged the time to first analgesia but also decreased the total amount of pethidine required post-operatively, with no significant adverse effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of gabapentin and dexamethasone alone or in combination for pain control after adenotonsillectomy in children. Amin, SM.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10464522/

Perioperative Gabapentin Usage in Pediatric Patients Of the studies assessing postoperative pain, 6/11 studies saw a decrease in postoperative pain in at least one period for the gabapentin group.

2. publications.aap.org publications.aap.org/hospitalpediatrics/article/14/1/e57/196219/Safety-and-Efficacy-of-Gabapentin-for-Pain-in

Safety and Efficacy of Gabapentin for Pain in Pediatric ... Opioid consumption was the primary outcome of this study, with secondary outcomes including pain score and adverse effects. Researchers found ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03005483

Gabapentin as Adjuvant for Postoperative Pain in Pediatric ... Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022346823001951

Gabapentin is Associated With Decreased Postoperative ... On adjusted analysis, children receiving gabapentin had 0.65 fewer days of postoperative total opioid use (95% CI: −1.09, −0.21) and spent 0.69 fewer days in ...

5. link.springer.com link.springer.com/article/10.1007/s44254-023-00024-4

Perioperative use of gabapentinoids in pediatric patients al demonstrated that a three-day perioperative gabapentin regimen reduces both acute post-operative pain scores (2.5 ± 2.8 vs. 6.0 ± 2.4, P < ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9836387/

Perioperative Indications for Gabapentinoids in Pediatrics Outcomes explored in the context of using gabapentinoids perioperatively in children are variable and include acute complications of pain, anxiety, nausea and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10771856/

Gabapentin is Associated With Decreased Postoperative ... On adjusted analysis, children receiving gabapentin had 0.65 fewer days of postoperative total opioid use (95% CI: −1.09, −0.21) and spent 0.69 fewer days in ...

8. clinicalpainadvisor.com clinicalpainadvisor.com/news/gabapentin-is-safe-for-pediatric-pain-but-efficacy-depends-on-pain-etiology/

Gabapentin Is Safe for Pediatric Pain but Efficacy Depends ... Gabapentin is safe to use as a multimodal analgesic agent in various pediatric patient populations, but its efficacy likely depends on the cause of pain.