Retinopathy of PrematurityNCT01872871
The Efficacy of Paracetamol in Reducing Pain During Ophthalmological Examination for Retinopathy of Prematurity: a Prospective Randomised Trial
A study testing Paracetamol in people with Retinopathy of Prematurity, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants. Although, local anesthetics reduce pain to some extent, eye examination still remains as a painful procedure. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Paracetamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age below 32 weeks or birth weight below 1500 grams
Who cannot join
- congenital anomalies, necrotising enterocolitis, surgical problems
Trial locations and contacts
1 site in 1 country.
Serdar Beken contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr. Sami Ulus Childrens Hospital
Ankara, 06080
Serdar Beken, M.D, 00903123056449, serbeken@gmail.com
Serdar Beken, M.D
About this study
Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants. Although, local anesthetics reduce pain to some extent, eye examination still remains as a painful procedure. The investigators aimed to evaluate the effect of oral paracetamol combined with local anesthetics for pain relief during ophthalmological examination.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Paracetamol, Topical anaesthetic drop with placebo
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
paracetamol with local anesthetic eye drop versus placebo with local anesthetic eye drops
Topical anaesthetic drop with placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| local anasthetic drops | Placebo comparator | topical anaesthetic drop with placebo Receives: Drug: Topical anaesthetic drop with placebo |
| Paracetamol | Active comparator | Topical anaesthetic drop with Paracetamol Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing pain assessment score
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Sami Ulus Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Beken, Dr. Sami Ulus Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872871
- Sponsor's protocol ID
- B.10.4.İSM.4.06.68.49/231
- Other IDs
- B.10.4.İSM.4.06.68.49
- Status last verified
- Jun 2013
- First submitted
- 4 Jun 2013
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Allegaert K, Tibboel D, Naulaers G, Tison D, De Jonge A, Van Dijk M, Vanhole C, Devlieger H. Systematic evaluation of pain in neonates: effect on the number of intravenous analgesics prescribed. Eur J Clin Pharmacol. 2003 Jun;59(2):87-90. doi: 10.1007/s00228-003-0585-3. Epub 2003 Apr 4.
PubMed 12682806
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Paracetamol in Reducing Pain During Ophthalmological Examination for Retinopathy of Prematurity: a Prospective Randomised Trial
- ClinicalTrials.gov ID
- NCT01872871
- Acronym / sponsor ID
- B.10.4.İSM.4.06.68.49/231
- Conditions
- Retinopathy of Prematurity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dr. Sami Ulus Children's HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retinopathy of prematurity (ROP) is one of the major morbidity among preterm infants. Although, local anesthetics reduce pain to some extent, eye examination still remains as a painful procedure. The investigators aimed to evaluate the effect of oral paracetamol combined with local anesthetics for pain relief during ophthalmological examination.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local anasthetic drops | Placebo comparator | Drug: Topical anaesthetic drop with placebotopical anaesthetic drop with placebo |
| Paracetamol | Active comparator | Drug: ParacetamolTopical anaesthetic drop with Paracetamol |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- gestational age below 32 weeks or birth weight below 1500 grams
Key exclusion criteria (1 listed)
- congenital anomalies, necrotising enterocolitis, surgical problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamolparacetamol with local anesthetic eye drop versus placebo with local anesthetic eye drops | Drug | Paracetamol |
| Topical anaesthetic drop with placebo | Drug | local anasthetic drops |
Primary outcome
Reducing pain assessment score
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
- Background: PubMed 12682806Allegaert K, Tibboel D, Naulaers G, Tison D, De Jonge A, Van Dijk M, Vanhole C, Devlieger H. Systematic evaluation of pain in neonates: effect on the number of intravenous analgesics prescribed. Eur J Clin Pharmacol. 2003 Jun;59(2):87-90. doi: 10.1007/s00228-003-0585-3. Epub 2003 Apr 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serdar Beken contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol in people with Retinopathy of Prematurity, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serdar Beken, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing pain assessment score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01872871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2013.