Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy
NCT ID: NCT03625011
Last Updated: 2019-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2018-07-31
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preoperative Gabapentin for Post-tonsillectomy Pain in Children
NCT01707420
How Does Gabapentin Affects Post-operative Tonsillectomy Pain?
NCT00624455
Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen
NCT02076893
Pain Management in Pediatric Adenotonsillectomy
NCT05928520
Post-operative Pain Control After Pediatric Adenotonsillectomy
NCT02296840
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo Group
Participants will be randomized to either Control Group or Gabapentin Group
Gabapentin
This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T/As. Patients will be receiving either one gabapentin dose (15mg/kg up to 600mg) or placebo preoperatively. Both control and test group will receive the standard narcotic regimen intraoperatively.
Gabapentin Group
Participants will be randomized to either Control Group or Gabapentin Group
Gabapentin
This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T/As. Patients will be receiving either one gabapentin dose (15mg/kg up to 600mg) or placebo preoperatively. Both control and test group will receive the standard narcotic regimen intraoperatively.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gabapentin
This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T/As. Patients will be receiving either one gabapentin dose (15mg/kg up to 600mg) or placebo preoperatively. Both control and test group will receive the standard narcotic regimen intraoperatively.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ASA class 1 or 2
* elective Tonsillectomy/Adenoidectomy
* outpatient setting.
Exclusion Criteria
* history of renal insufficiency, chronic pain
* allergy to gabapentin
* history of developmental delay
3 Years
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Children's Healthcare of Atlanta
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Margaret Gettis
Nurse Scientist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christina Calamaro, PhD, CPNP-PC
Role: STUDY_CHAIR
Institutional Review Board
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Amani S, Abedinzadeh MR. Effects of Oral Gabapentin, Local Bupivacaine and Intravenous Pethidine on Post Tonsillectomy Pain. Iran J Otorhinolaryngol. 2015 Sep;27(82):343-8.
Amin SM. Evaluation of gabapentin and dexamethasone alone or in combination for pain control after adenotonsillectomy in children. Saudi J Anaesth. 2014 Jul;8(3):317-22. doi: 10.4103/1658-354X.136417.
Amin SM, Amr YM. Comparison between preemptive gabapentin and paracetamol for pain control after adenotonsillectomy in children. Anesth Essays Res. 2011 Jul-Dec;5(2):167-70. doi: 10.4103/0259-1162.94758.
Hwang SH, Park IJ, Cho YJ, Jeong YM, Kang JM. The efficacy of gabapentin/pregabalin in improving pain after tonsillectomy: A meta-analysis. Laryngoscope. 2016 Feb;126(2):357-66. doi: 10.1002/lary.25636. Epub 2015 Sep 25.
Knipper E, Banta-Green CJ, Jimenez N. Opioid use disorder and misuse: A review of the epidemiology and medical implications for pediatric anesthesiologists. Paediatr Anaesth. 2017 Nov;27(11):1070-1076. doi: 10.1111/pan.13225.
Mohamed, M.H., Al-Sercy, H. (2014). Preoperative gabapentin decreases the incidence of postoperative vomiting and analgesic requirements after pediatric adenotonsillectomy. The Egyptian Journal of Otolaryngology. 225-228.
Thiels CA, Anderson SS, Ubl DS, Hanson KT, Bergquist WJ, Gray RJ, Gazelka HM, Cima RR, Habermann EB. Wide Variation and Overprescription of Opioids After Elective Surgery. Ann Surg. 2017 Oct;266(4):564-573. doi: 10.1097/SLA.0000000000002365.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB 18-052
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.