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Trial record 16 of 74 for:    Codeine AND Acetaminophen

Codeine Plus Paracetamol Versus Placebo for PRK Post-operative Pain

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ClinicalTrials.gov Identifier: NCT02625753
Recruitment Status : Completed
First Posted : December 9, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Vinicius Borges Porfirio Pereira, University of Sao Paulo General Hospital

Brief Summary:
Compare the use of codeine/paracetamol against placebo for pain control after cornea photorefractive keratectomy (PRK).

Condition or disease Intervention/treatment Phase
Myopia Drug: Codeine Drug: paracetamol Drug: placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Study of Codeine Plus Paracetamol Versus Placebo for PRK Post-operative Pain
Study Start Date : November 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Codeine

Arm Intervention/treatment
Active Comparator: Codeine plus paracetamol
Codeine plus paracetamol every 6 hours for 72 hours after photorefractive keratectomy.
Drug: Codeine
Patients submitted to photorefractive keratectomy received codeine 50mg plus paracetamol 500mg every 6h for 72h after the procedure
Other Name: 3-methylmorphine

Drug: paracetamol
Patients submitted to photorefractive keratectomy received codeine 50mg plus paracetamol 500mg every 6h for 72h after the procedure
Other Name: acetaminophen

Placebo Comparator: placebo
Placebo every 6 hours for 72 hours after photorefractive keratectomy.
Drug: placebo
Patients submmitted to photorefractive keratectomy received placebo, in the form of a pill of similar appearance to the comparator, every 6h for 72h after the




Primary Outcome Measures :
  1. Pain measured by visual-analog scale 24hour after PRK [ Time Frame: 24hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • older than 20 years
  • spherical component between -1.00 and -5.00, with or without astigmatism
  • cylindrical component up to 1.5D
  • spherical anisometropia of less than or equal to 0.75D,
  • cylindrical anisometropia of less than or equal to 0.5D,
  • stable refraction errors (maximal variation of 0.5D in the spherical or cylindrical component during 1 year)
  • amenable to follow-up for at least seven (7) days.

Exclusion Criteria:

  • presence of active disease of allergic, inflammatory or infectious nature, in the ocular surface or its attachments
  • previous ocular history (pathology, surgery or ocular trauma)
  • best corrected visual acuity less than 20/25)
  • autoimmune disease, or immunosuppression or Diabetes Mellitus
  • pregnancy or lactation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625753


Locations
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Brazil
Universidade de São Paulo (USP) - Refractive surgery department
São Paulo, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Director: Samir Bechara, MD Universidade de São Paulo - USP

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vinicius Borges Porfirio Pereira, MD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02625753     History of Changes
Other Study ID Numbers: CAAE : 37084214.3.0000.0068
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by Vinicius Borges Porfirio Pereira, University of Sao Paulo General Hospital:
photorefractive keratectomy
pain
analgesia
opioid
Additional relevant MeSH terms:
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Acetaminophen
Codeine
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents