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NCT03393702

Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin

Completed Phase 4 Last updated 8 September 2021
What this trial tests

Phase 4 trial testing Gabapentin in Pain, Postoperative in 104 participants. Completed in 3 December 2020.

Timeline
9 May 2017
Primary endpoint
30 December 2019
3 December 2020

Quick facts

Lead sponsorNational Institute for Tuberculosis and Lung Diseases, Poland
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment104
Start date9 May 2017
Primary completion30 December 2019
Estimated completion3 December 2020
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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:

Other trials of Gabapentin

Trials testing the same drug.

Other recruiting trials for Pain, Postoperative

Currently open trials in the same condition.

Other National Institute for Tuberculosis and Lung Diseases, Poland trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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