<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03005483</url>
  </required_header>
  <id_info>
    <org_study_id>HOSPITALIAS</org_study_id>
    <nct_id>NCT03005483</nct_id>
  </id_info>
  <brief_title>Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery</brief_title>
  <official_title>Placebo Controlled, Randomized,Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Infantil Albert Sabin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fortaleza University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Infantil Albert Sabin</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral&#xD;
      10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in&#xD;
      children from 3 months to 16 years submitted unilateral limb surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral&#xD;
      10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in&#xD;
      children from 3 months to 16 years submitted unilateral limb surgery. The children were&#xD;
      divided into 2 groups: the gabapentin group (GG) was administered gabapentin 1 to 2 hours&#xD;
      before procedure (N-40) and the placebo group (GP) was administered placebo 1 to 2 hours&#xD;
      before surgery (N-44). Both groups were subjected to the same general anesthesia protocol,&#xD;
      opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received&#xD;
      dipyrone and rescue analgesic used was morphine into 2/2h. The variables studied were age,&#xD;
      gender, weight, type of surgery, hemodynamics, postoperative pain and morphine consumption .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduce the pain intensity using the Face Pain Scale</measure>
    <time_frame>24 hour</time_frame>
    <description>Subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%.The evaluation times were: 1 hour, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours after surgery. The time elapsed was recorded, from the end of the surgery to the first use of morphine. The parents and the patients themselves were instructed to request analgesic at any time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduce the opioid consumption through 24 hours postoperative observation</measure>
    <time_frame>24 hour</time_frame>
    <description>Subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received dipyrone and rescue analgesic used was administered morphine 50mcg / kg (maximum dose of 2mg) up to 2 / 2h when Face´s Scales reached 5 points.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Orthopedic Disorder</condition>
  <arm_group>
    <arm_group_label>Gabapentin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gabapentin 10 mg/kg in children submitted unilateral limb surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo in children submitted unilateral limb surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>Orthopedic Surgery was applied for the treatment of osseous disorders</description>
    <arm_group_label>Gabapentin</arm_group_label>
    <other_name>Orthopedic Surgery</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Orthopedic Surgery was applied for the treatment of osseous disorders</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Children between 3 months and 16 years who were previously healthy submitted to unilateral&#xD;
        lower limb surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Children cardiac, pulmonary, renal and neurological diseases and allergy and refusal of&#xD;
        parents, caregivers and patients to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Josenília Gomes, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Fortaleza University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Infantil Albert Sabin</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceara</state>
        <zip>60410794</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>20418301</PMID>
  </reference>
  <reference>
    <citation>Mayell 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.</citation>
    <PMID>25230144</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 28, 2016</last_update_submitted>
  <last_update_submitted_qc>December 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Infantil Albert Sabin</investigator_affiliation>
    <investigator_full_name>washington aspilicueta pinto filho</investigator_full_name>
    <investigator_title>Medical Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>GABAPENTIN POSTOPERATIVE PAIN CHILD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gabapentin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03005483
org study id: HOSPITALIAS
nct id: NCT03005483
lead sponsor: 
collaborator: 
has dmc: Yes
This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral
      10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in
      children from 3 months to 16 years submitted unilateral limb surgery.
This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral
      10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in
      children from 3 months to 16 years submitted unilateral limb surgery. The children were
      divided into 2 groups: the gabapentin group (GG) was administered gabapentin 1 to 2 hours
      before procedure (N-40) and the placebo group (GP) was administered placebo 1 to 2 hours
      before surgery (N-44). Both groups were subjected to the same general anesthesia protocol,
      opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received
      dipyrone and rescue analgesic used was morphine into 2/2h. The variables studied were age,
      gender, weight, type of surgery, hemodynamics, postoperative pain and morphine consumption .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Reduce the pain intensity using the Face Pain Scale
time frame: 24 hour
description: Subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%.The evaluation times were: 1 hour, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours after surgery. The time elapsed was recorded, from the end of the surgery to the first use of morphine. The parents and the patients themselves were instructed to request analgesic at any time.
measure: Reduce the opioid consumption through 24 hours postoperative observation
time frame: 24 hour
description: Subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received dipyrone and rescue analgesic used was administered morphine 50mcg / kg (maximum dose of 2mg) up to 2 / 2h when Face´s Scales reached 5 points.
arm group label: Gabapentin
arm group type: Experimental
description: Gabapentin 10 mg/kg in children submitted unilateral limb surgery
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo in children submitted unilateral limb surgery
intervention type: Drug
intervention name: Gabapentin
description: Orthopedic Surgery was applied for the treatment of osseous disorders
arm group label: Gabapentin
other name: Orthopedic Surgery
intervention type: Other
intervention name: Placebo
description: Orthopedic Surgery was applied for the treatment of osseous disorders
arm group label: Placebo
criteria: 
gender: All
minimum age: 3 Months
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Josenília Gomes, PhD
role: Study Chair
affiliation: Fortaleza University
facility: 
country: Brazil
citation: 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.
PMID: 20418301
citation: Mayell 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.
PMID: 25230144
responsible party type: Principal Investigator
investigator affiliation: Hospital Infantil Albert Sabin
investigator full name: washington aspilicueta pinto filho
investigator title: Medical Anesthesiologist
mesh term: Musculoskeletal Diseases
mesh term: Pain, Postoperative
mesh term: Gabapentin
sharing ipd: No