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

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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Codeine plus paracetamol
Codeine plus paracetamol every 6 hours for 72 hours after photorefractive keratectomy.
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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.
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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 |
- Pain measured by visual-analog scale 24hour after PRK [ Time Frame: 24hour ]

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

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
Brazil | |
Universidade de São Paulo (USP) - Refractive surgery department | |
São Paulo, Brazil, 05403-900 |
Study Director: | Samir Bechara, MD | Universidade de São Paulo - USP |
Responsible Party: | Vinicius Borges Porfirio Pereira, MD, University of Sao Paulo General Hospital |
ClinicalTrials.gov Identifier: | NCT02625753 |
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 |
photorefractive keratectomy pain analgesia opioid |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Acetaminophen Codeine 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 |