NCT02625753

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

November 29, 2015

Last Update Submit

December 9, 2015

Conditions

Myopia

Keywords

photorefractive keratectomypainanalgesiaopioid

Outcome Measures

Primary Outcomes (1)

  • Pain measured by visual-analog scale 24hour after PRK

    24hour

Study Arms (2)

Codeine plus paracetamol

ACTIVE COMPARATOR

Codeine plus paracetamol every 6 hours for 72 hours after photorefractive keratectomy.

Drug: CodeineDrug: paracetamol

placebo

PLACEBO COMPARATOR

Placebo every 6 hours for 72 hours after photorefractive keratectomy.

Drug: placebo

Interventions

CodeineDRUG

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

Also known as: 3-methylmorphine
Codeine plus paracetamol
paracetamolDRUG

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

Also known as: acetaminophen
Codeine plus paracetamol
placeboDRUG

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

placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de São Paulo (USP) - Refractive surgery department

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (2)

  • Pereira VBP, Torriceli AAM, Garcia R, Bechara SJ, Alves MR. Codeine plus acetaminophen improve sleep quality, daily activity level, and food intake in the early postoperative period after photorefractive keratectomy: a secondary analysis. Arq Bras Oftalmol. 2021 Jan-Feb;84(1):45-50. doi: 10.5935/0004-2749.20210008.

    PMID: 33470341DERIVED

  • Pereira VBP, Garcia R, Torricelli AAM, Mukai A, Bechara SJ. Codeine Plus Acetaminophen for Pain After Photorefractive Keratectomy: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial. Cornea. 2017 Oct;36(10):1206-1212. doi: 10.1097/ICO.0000000000001328.

    PMID: 28820793DERIVED

MeSH Terms

Conditions

MyopiaPainAgnosia

Interventions

CodeineAcetaminophen

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Samir Bechara, MD

    Universidade de São Paulo - USP

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 29, 2015

First Posted

December 9, 2015

Study Start

November 1, 2014

Primary Completion

June 1, 2015

Study Completion

October 1, 2015

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

BR(1)