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NCT03393702
Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin
Phase 4 trial testing Gabapentin in Pain, Postoperative in 104 participants. Completed in 3 December 2020.
30 December 2019
Quick facts
| Lead sponsor | National Institute for Tuberculosis and Lung Diseases, Poland |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 9 May 2017 |
| Primary completion | 30 December 2019 |
| Estimated completion | 3 December 2020 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Gabapentin (Gabapentin) — full drug profile →
- Placebo
Conditions studied
- Pain, Postoperative — all drugs for Pain, Postoperative →
- Surgery, Thoracic — all drugs for Surgery, Thoracic →
Sponsor
National Institute for Tuberculosis and Lung Diseases, Poland
Who can join
Adults 5 to 18, any sex, with Pain, Postoperative or Surgery, Thoracic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is performed in patients aged 5-18 years after thoracic surgery. The primary aim of this trial is to determine whether the use of gabapentin as a component of multimodal analgesic regiments reduces pain scores following thoracic surgery in pediatric patients. The secondary objective of the trial are to evaluate whether the use of gabapentin reduces postoperative anxiety scores and consumption of ropivacaine with fentanyl, decreases side-effects, and improves patient satisfaction.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Effects of Gabapentin on Post-Operative Pain and Anxiety, Morphine Consumption and Patient Satisfaction in Paediatric Patients Following the Ravitch Procedure-A Randomised, Double-Blind, Placebo-Controlled, Phase 4 Trial.
Fenikowski D, Tomaszek L, Mazurek H, Gawron D, et al · · 2022 · cited 7× · PMID 36012932 · DOI 10.3390/jcm11164695 -
Factors Related to Anxiety in Paediatric Patients and Their Parents before and after a Modified Ravitch Procedure-A Single-Centre Cohort Study.
Fenikowski D, Tomaszek L. · · 2022 · cited 3× · PMID 36554581 · DOI 10.3390/ijerph192416701 -
Intravenous Morphine Infusion versus Thoracic Epidural Infusion of Ropivacaine with Fentanyl after the Ravitch Procedure-A Single-Center Cohort Study.
Fenikowski D, Tomaszek L. · · 2022 · cited 3× · PMID 36141560 · DOI 10.3390/ijerph191811291 -
Maximum Pain at Rest in Pediatric Patients Undergoing Elective Thoracic Surgery and the Predictors of Moderate-to-Severe Pain-Secondary Data Analysis.
Tomaszek L, Fenikowski D, Cież-Piekarczyk N, Mędrzycka-Dąbrowska W. · · 2024 · cited 2× · PMID 38337538 · DOI 10.3390/jcm13030844
Verify or expand the search:
- PubMed search for NCT03393702
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Gabapentin
Trials testing the same drug.
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- NCT04613024 — Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty · EARLY_PHASE1 · withdrawn
- NCT07389551 — Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic · NA · completed
- NCT06992427 — High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Che · Phase 3 · recruiting
Other recruiting trials for Pain, Postoperative
Currently open trials in the same condition.
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- NCT06740214 — Analgesic Efficacy of Different Liposomal Bupivacaine Doses in the Adductor Canal Block for Total Knee Arthroplasty · Phase 3 · recruiting
- NCT07057557 — Aloe Vera vs Paraffin Tulle Dressings for Pain Management in Split Thickness Skin Graft Donor Sites · NA · recruiting
Other National Institute for Tuberculosis and Lung Diseases, Poland trials
Trials by the same sponsor.
- NCT05752708 — Perioperative Anxiety Risk Factors in Parents of Children Undergoing Thoracic Surgery · recruiting
- NCT06964074 — PEP and O-PEP Device for Nebulization in Cystic Fibrosis · NA · active not recruiting
- NCT04916834 — Impact of Severe Acute Respiratory Syndrome (SARS-CoV-2/COVID-19) Related Pneumonia on Lung Function and Structure. · unknown
- NCT04036721 — Coorticosteroid Regimen in Patients With Anti-PD-1/PD-L1 Induced Pneumonitis · Phase 4 · suspended
- NCT04509921 — Adjustment of Asthma Treatment in Children Based on an Indirect Hyperresponsiveness Test · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03393702 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute for Tuberculosis and Lung Diseases, Poland
- Last refreshed: 8 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03393702.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing