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

Trial Summary

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.

What data supports the effectiveness of the drug gabapentin for postoperative pain in children?

Research in adults shows gabapentin can help with pain after surgery, and studies suggest it might reduce the need for strong painkillers like morphine. However, there is limited direct evidence for its use in children after surgery. ^{1 2 3 4 5}

Is gabapentin safe for use in children for postoperative pain?

Gabapentin is often used off-label for pain management in children, and studies have looked at its safety when used with other pain medications like morphine. While it is generally considered safe, its use in children for postoperative pain is still being studied to ensure there are no unexpected side effects. ^{1 2 6 7 8}

How is the drug gabapentin unique for treating postoperative pain in children?

Gabapentin is unique because it is used off-label as an opioid-sparing medication, meaning it can reduce the need for stronger painkillers like morphine after surgery. It is also being studied in a new liquid form specifically for children, which could make it easier to administer. ^{6 8 9 10 11}

What is the purpose of this trial?

The primary objective of this study is to determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after thoracic surgery. We hypothesize that patients who are given gabapentin will need fewer morphine equivalents postoperatively than those who were not given gabapentin

Eligibility Criteria

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 under 18 years old.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Does the addition of post-operative gabapentin reduce the use of narcotics after orthopedic surgery? [2023]

2. England 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). [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Evidence for the Efficacy of Systemic Opioid-Sparing Analgesics in Pediatric Surgical Populations: A Systematic Review. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Reanalysis of morphine consumption from two randomized controlled trials of gabapentin using longitudinal statistical methods. [2022]

5. Netherlands 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. [2022]

6. England 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. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The efficacy of gabapentin in reducing pain intensity and morphine consumption after breast cancer surgery: A meta-analysis. [2022]

8. United States 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Single dose oral gabapentin for established acute postoperative pain in adults. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of gabapentin as a postoperative analgesic in children undergoing appendectomy. [2020]

11. India pubmed.ncbi.nlm.nih.gov

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