Pain, PostoperativePhase 4NCT03393702
Pain Control in Children and Adolescent After Thoracic Surgery: The Effect of Gabapentin
A Phase 4 study testing Gabapentin in people with Pain, Postoperative and Surgery, Thoracic, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Pain, Postoperative, Surgery, Thoracic
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 sitePoland
- Study dates
- 9 May 2017to 3 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 5 - 18 years of age;
- surgery: lateral thoracotomy or Ravitch procedure;
- ASA 1-3;
- postoperative analgesia: thoracic epidural analgesia or intravenous infusion of morphine.
Who cannot join
- allergy or sensitivity to gabapentin;
- history of chronic pain or daily analgesic use;
- diagnosed with psychiatric disorders;
- treated oncologically;
- with impaired verbal communication;
- the lack of postoperative chest drainage.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Institute for Tuberculosis and Lung Diseases, Pediatric Division
Rabka-Zdrój, Małopolska, 34-700
About this study
Official title: Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study
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.
Read the detailed description
The subjects are randomized to the Gabapentin or Placebo group. All patients receive preoperative gabapentin (15 mg/kg, treatment) or placebo, respectively and after surgery either gabapentin (7,5 mg/kg, treatment) or placebo 2 times per day for 3 days, respectively.
Patients are subjected to the same anaesthesia protocol. Postoperative analgesia are achieved with either continuous ropivacaine 0.2%/fentanyl 5.0 μg/ml infusion through a thoracic epidural catheter (N=40; Gabapentin n=20, Placebo n=20), or intravenous infusion of morphine (N=40; Gabapentin n=20, Placebo n=20). All patients receive acetaminophen and non-steroidal anti-inflammatory drugs, and metamizol as a "rescue drug"
The intravenous infusion of morphine grup was expanded on the basis of the bioethics commission's decision KB-125/2019 (N=64; Gabapentin n=32, Placebo n=32).
- Conditions
- Pain, Postoperative, Surgery, Thoracic
- Being tested
- Gabapentin, Placebo
- Keywords
- Postoperative pain, Anxiety, Postoperative Complications, Patient Satisfaction
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Postoperative Complications, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Gabapentin TEVA, capsules
- Patients in this arm of the study receive identical capsules, containing 15 mg/kg of oral gabapentin.
- Patients after surgery receive identical capsules, containing 7,5 mg/kg of oral gabapentin 2 times per day.
PlaceboDrug
- Patients in this arm of the study receive identical placebo capsules 1 hour before surgery.
- Patients after surgery receive identical placebo capsules 2 times per day.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | 1. Single dose preoperative gabapentin.
2. After surgery gabapentin 2 times per day for 3 days. Receives: Drug: Gabapentin |
| Placebo Control | Placebo comparator | 1. Single dose preoperative placebo control.
2. After surgery placebo 2 times per day for 3 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Measured: postoperative day: 0-3
Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Measured: postoperative day: 0-3
Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Measured: postoperative day: 0-3
Secondary outcomes (6)
Total ropivacaine/fentanyl consumption.
Measured: postoperative day: 0-3
Total morphine consumption.
Measured: postoperative day: 0-3
Anxiety intensity scores.
Patients rate their anxiety using State-Trait Anxiety Inventory.
Measured: before surgery, postoperative day 3
Side Effect Occurrence
Incidence and severity of nausea, vomiting, pruritis, sedation, dizziness, urinary retention, complication in relation to administering of the drugs to epidural space.
Measured: first 3 days after surgery
The number of doses of metamizol as a "rescue drug"
Measured: postoperative day: 0-3
Patient satisfaction.
Responses can range from 0 (very dissatisfied) to 10 (very satisfied).
Measured: first 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start9 May 2017
- Primary completion30 Dec 2019
- Study completion3 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucyna Tomaszek, PhD, RN, National Institute for Tuberculosis and Lung Diseases, Poland
- Investigators
- Lucyna Tomaszek, PhD, Study director, National Institute for Tuberculosis and Lung Diseases, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393702
- Sponsor's protocol ID
- 10.11
- Status last verified
- Aug 2021
- First submitted
- 28 Dec 2017
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.
PubMed 20418301Mayell A, Srinivasan I, Campbell F, Peliowski A. Analgesic effects of gabapentin after scoliosis surgery in children: a randomized controlled trial. Paediatr Anaesth. 2014 Dec;24(12):1239-44. doi: 10.1111/pan.12524. Epub 2014 Sep 17.
PubMed 25230144Tomaszek L, Fenikowski D, Maciejewski P, Komotajtys H, Gawron D. Perioperative Gabapentin in Pediatric Thoracic Surgery Patients-Randomized, Placebo-Controlled, Phase 4 Trial. Pain Med. 2020 Aug 1;21(8):1562-1571. doi: 10.1093/pm/pnz207.
PubMed 31596461Fenikowski D, Tomaszek L. Factors Related to Anxiety in Paediatric Patients and Their Parents before and after a Modified Ravitch Procedure-A Single-Centre Cohort Study. Int J Environ Res Public Health. 2022 Dec 12;19(24):16701. doi: 10.3390/ijerph192416701.
PubMed 36554581
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study
- ClinicalTrials.gov ID
- NCT03393702
- Acronym / sponsor ID
- 10.11
- Conditions
- Pain, Postoperative, Surgery, Thoracic
- Keywords
- Postoperative pain, Anxiety, Postoperative Complications, Patient Satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, PolandUniversity, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The subjects are randomized to the Gabapentin or Placebo group. All patients receive preoperative gabapentin (15 mg/kg, treatment) or placebo, respectively and after surgery either gabapentin (7,5 mg/kg, treatment) or placebo 2 times per day for 3 days, respectively.
Patients are subjected to the same anaesthesia protocol. Postoperative analgesia are achieved with either continuous ropivacaine 0.2%/fentanyl 5.0 μg/ml infusion through a thoracic epidural catheter (N=40; Gabapentin n=20, Placebo n=20), or intravenous infusion of morphine (N=40; Gabapentin n=20, Placebo n=20). All patients receive acetaminophen and non-steroidal anti-inflammatory drugs, and metamizol as a "rescue drug"
The intravenous infusion of morphine grup was expanded on the basis of the bioethics commission's decision KB-125/2019 (N=64; Gabapentin n=32, Placebo n=32).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: Gabapentin1. Single dose preoperative gabapentin. 2. After surgery gabapentin 2 times per day for 3 days. |
| Placebo Control | Placebo comparator | Drug: Placebo1. Single dose preoperative placebo control. 2. After surgery placebo 2 times per day for 3 days. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 5 - 18 years of age;
- surgery: lateral thoracotomy or Ravitch procedure;
- ASA 1-3;
- postoperative analgesia: thoracic epidural analgesia or intravenous infusion of morphine.
Key exclusion criteria (6 listed)
- allergy or sensitivity to gabapentin;
- history of chronic pain or daily analgesic use;
- diagnosed with psychiatric disorders;
- treated oncologically;
- with impaired verbal communication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinAlso: Gabapentin TEVA, capsules1. Patients in this arm of the study receive identical capsules, containing 15 mg/kg of oral gabapentin. 2. Patients after surgery receive identical capsules, containing 7,5 mg/kg of oral gabapentin 2 times per day. | Drug | Gabapentin |
| Placebo1. Patients in this arm of the study receive identical placebo capsules 1 hour before surgery. 2. Patients after surgery receive identical placebo capsules 2 times per day. | Drug | Placebo Control |
Primary outcome
Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Time frame: postoperative day: 0-3
Pain intensity scores during deep breathing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Time frame: postoperative day: 0-3
Pain intensity scores during coughing (FLACC for patients <7 y.o., NRS for patients >7 y.o.)
Time frame: postoperative day: 0-3
6 secondary outcomes
Total ropivacaine/fentanyl consumption.
Time frame: postoperative day: 0-3
Total morphine consumption.
Time frame: postoperative day: 0-3
Anxiety intensity scores.
Time frame: before surgery, postoperative day 3
Side Effect Occurrence
Time frame: first 3 days after surgery
The number of doses of metamizol as a "rescue drug"
Time frame: postoperative day: 0-3
Patient satisfaction.
Time frame: first 3 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Background: PubMed 20418301Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.
- Background: PubMed 25230144Mayell A, Srinivasan I, Campbell F, Peliowski A. Analgesic effects of gabapentin after scoliosis surgery in children: a randomized controlled trial. Paediatr Anaesth. 2014 Dec;24(12):1239-44. doi: 10.1111/pan.12524. Epub 2014 Sep 17.
- Background: PubMed 31596461Tomaszek L, Fenikowski D, Maciejewski P, Komotajtys H, Gawron D. Perioperative Gabapentin in Pediatric Thoracic Surgery Patients-Randomized, Placebo-Controlled, Phase 4 Trial. Pain Med. 2020 Aug 1;21(8):1562-1571. doi: 10.1093/pm/pnz207.
- Derived from this study: PubMed 36554581Fenikowski D, Tomaszek L. Factors Related to Anxiety in Paediatric Patients and Their Parents before and after a Modified Ravitch Procedure-A Single-Centre Cohort Study. Int J Environ Res Public Health. 2022 Dec 12;19(24):16701. doi: 10.3390/ijerph192416701.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucyna Tomaszek, PhD study director
National Institute for Tuberculosis and Lung Diseases, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin in people with Pain, Postoperative and Surgery, Thoracic, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity scores at rest (FLACC for patients <7 y.o., NRS for patients >7 y.o.) (time frame: postoperative day: 0-3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03393702, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.