<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/NCT01672112</url>
  </required_header>
  <id_info>
    <org_study_id>2011/02076</org_study_id>
    <nct_id>NCT01672112</nct_id>
  </id_info>
  <brief_title>Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain</brief_title>
  <official_title>Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tan Tock Seng Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tan Tock Seng Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The efficacy of codeine is dependent on its demethylation to morphine. This extent of&#xD;
      demethylation has wide inter-individual variability, making codeine's efficacy as a analgesic&#xD;
      variable. Oxycodone is a semi-synthetic opioid and is a weak agonist on mu opioid receptors.&#xD;
&#xD;
      Codeine has been the mainstay of analgesia for patients after craniotomy for many years.&#xD;
      Traditionally, craniotomies were not thought to be very painful procedures, hence the use of&#xD;
      codeine, a moderately potent opioid (when compared to morphine).&#xD;
&#xD;
      However, in recent years, it has been found that up to 70% of post-craniotomy patients have&#xD;
      moderate to severe pain and codeine did not provide adequate analgesic relief. Many studies&#xD;
      have compared codeine to other drugs such as PCA morphine, fentanyl and tramadol, and&#xD;
      patients on these stronger opioids generally had lower pain scores and better satisfaction.&#xD;
&#xD;
      No study has been conducted to determine the efficacy of analgesia of oral oxycodone to oral&#xD;
      codeine.&#xD;
&#xD;
      Hence, the hypothesis is that oxycodone is more effective than codeine in providing pain&#xD;
      relief in post-craniotomy patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">January 2015</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the difference in the mean pain VAS scores in the oxycodone and codeine groups at 24hr.</measure>
    <time_frame>24hr post-op.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To look at the incidence of adverse events in the oxycodone and codeine groups.</measure>
    <time_frame>Up to 72hrs post-op.</time_frame>
    <description>To compare the incidence of excessive sedation, respiratory depression and GCS; to compare the pain VAS scores at 48 and 72hrs post-op; to compare the mean satisfaction scores at 24 and 72hrs post-op.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Postcraniotomy Pain</condition>
  <arm_group>
    <arm_group_label>Codeine</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Oral Codeine 60mg 6hrly/prn</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxycodone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral Oxycodone 5mg 6hrly/prn</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>Oral Oxycodone 5mg 6hrly/prn</description>
    <arm_group_label>Oxycodone</arm_group_label>
    <other_name>Oxynorm Immediate Release</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Codeine</intervention_name>
    <description>Oral Codeine 60mg 6hrly/prn</description>
    <arm_group_label>Codeine</arm_group_label>
    <other_name>Codeine Phosphate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 21-70 years of age&#xD;
&#xD;
          -  Planned elective craniotomy&#xD;
&#xD;
          -  ASA 1-3&#xD;
&#xD;
          -  GCS 15 pre and post-op&#xD;
&#xD;
          -  Able to understand and use the visual analogue scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with GCS &lt; 15 pre and/or post-op.&#xD;
&#xD;
          -  Patients who are unable to quantify pain according to VAS scale.&#xD;
&#xD;
          -  Patients who will be left intubated post-op.&#xD;
&#xD;
          -  Contraindications and/or allergies to any of the trial drugs.&#xD;
&#xD;
          -  Patients with renal and/or hepatic impairment.&#xD;
&#xD;
          -  Patients with decreased respiratory reserves.&#xD;
&#xD;
          -  Patients with post-op cognitive dysfunction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tan Tock Seng Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>308433</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>May 13, 2015</last_update_submitted>
  <last_update_submitted_qc>May 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tan Tock Seng Hospital</investigator_affiliation>
    <investigator_full_name>Lim Pei-Pei Mandy</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <keyword>analgesic efficacy</keyword>
  <keyword>oral codeine</keyword>
  <keyword>oral oxycodone</keyword>
  <keyword>postcraniotomy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxycodone</mesh_term>
    <mesh_term>Codeine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01672112
org study id: 2011/02076
nct id: NCT01672112
lead sponsor: 
has dmc: Yes
The efficacy of codeine is dependent on its demethylation to morphine. This extent of
      demethylation has wide inter-individual variability, making codeine's efficacy as a analgesic
      variable. Oxycodone is a semi-synthetic opioid and is a weak agonist on mu opioid receptors.

      Codeine has been the mainstay of analgesia for patients after craniotomy for many years.
      Traditionally, craniotomies were not thought to be very painful procedures, hence the use of
      codeine, a moderately potent opioid (when compared to morphine).

      However, in recent years, it has been found that up to 70% of post-craniotomy patients have
      moderate to severe pain and codeine did not provide adequate analgesic relief. Many studies
      have compared codeine to other drugs such as PCA morphine, fentanyl and tramadol, and
      patients on these stronger opioids generally had lower pain scores and better satisfaction.

      No study has been conducted to determine the efficacy of analgesia of oral oxycodone to oral
      codeine.

      Hence, the hypothesis is that oxycodone is more effective than codeine in providing pain
      relief in post-craniotomy patients.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: To determine the difference in the mean pain VAS scores in the oxycodone and codeine groups at 24hr.
time frame: 24hr post-op.
measure: To look at the incidence of adverse events in the oxycodone and codeine groups.
time frame: Up to 72hrs post-op.
description: To compare the incidence of excessive sedation, respiratory depression and GCS; to compare the pain VAS scores at 48 and 72hrs post-op; to compare the mean satisfaction scores at 24 and 72hrs post-op.
arm group label: Codeine
arm group type: Other
description: Oral Codeine 60mg 6hrly/prn
arm group label: Oxycodone
arm group type: Active Comparator
description: Oral Oxycodone 5mg 6hrly/prn
intervention type: Drug
intervention name: Oxycodone
description: Oral Oxycodone 5mg 6hrly/prn
arm group label: Oxycodone
other name: Oxynorm Immediate Release
intervention type: Drug
intervention name: Codeine
description: Oral Codeine 60mg 6hrly/prn
arm group label: Codeine
other name: Codeine Phosphate
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Tan Tock Seng Hospital
investigator full name: Lim Pei-Pei Mandy
investigator title: Consultant
mesh term: Oxycodone
mesh term: Codeine