StrabismusPhase 2NCT06689943
Pain After Strabismus Surgery
A Phase 2 study testing Tylenol in people with Strabismus, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
At Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's), the current practice is to prescribe children with oral Tylenol as needed every 4-6 hours post strabismus surgery. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Strabismus
- What is being tested?
- Tylenol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Dec 2030
- Phase
- Phase 2
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 4-12 years old
- Children receiving single muscle, bilateral horizontal strabismus surgery (that is, children who are having only one horizontal eye muscle in each eye operated on) at Lurie Children's hospital in Chicago, IL
- ASA classification 1 or 2. Note: ASA is a physical status classification system (scale of 1-6) created by the American Society of Anesthesiologists to describe patients prior to surgery. ASA 1 or 2 means the patient is either healthy or has mild systemic disease prior to surgery.
Who cannot join
- ASA classification 3 or higher (patient has severe systemic disease or worse)
- Contraindication to toradol (anesthesia)
- Contraindication to acetaminophen
- Previous strabismus surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Pain After Strabismus Surgery: Post-Operative Outcomes Using Courses of Acetaminophen in Children
At Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's), the current practice is to prescribe children with oral Tylenol as needed every 4-6 hours post strabismus surgery. Prescribing Tylenol "as needed" leaves more room for error for parents to be under-dosing their children, which can lead to avoidable pain. This study aims to figure out if children ages 4-12 years old will feel significantly less pain and discomfort when given regimented Tylenol every 6 hours for 48 hours after strabismus surgery (eye muscle surgery) compared to controls whose parents are instructed to give Tylenol every 4-6 hours as needed for 48 hours after surgery. To date, there have been no studies comparing patient outcomes between those taking Tylenol regimen and those receiving Tylenol as needed after pediatric surgery.
Read the detailed description
Main hypothesis:
Children ages 4-12 years will feel significantly less pain and discomfort when given regimented Tylenol every 6 hours for 48 hours after strabismus surgery (surgery to correct misaligned eyes) compared to controls whose parents are instructed to give Tylenol every 4-6 hours as needed for 48 hours after surgery.
Primary Objective At Lurie Children's, the current standard practice is for patients to be prescribed oral acetaminophen as needed every 4-6 hours after strabismus surgery. However, making the acetaminophen "as needed" leaves room for error for parents to be underdosing their children and, thus, leads to increased pain felt by these pediatric patients. To date, there have been no studies comparing patient satisfaction outcomes between a group taking a course of scheduled acetaminophen every 6 hours and to a group instructed to take as needed. The investigators plan to study the differences between these two groups by using the Parent's Post-operative Pain Measure (PPPM) questionnaire to survey parents and the Faces Pain Scale-Revised to survey children at their post-operative appointment.
- Conditions
- Strabismus
- Being tested
- Tylenol
- Keywords
- pain, strabismus surgery
- Medical subject headings
- Strabismus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TylenolDrug
Also called acetaminophen
Tylenol for children
| Study group | Role | What they receive |
|---|---|---|
| Tylenol as needed | Active comparator | Tylenol prescribed to be taken as needed for pain management for 48 hours after surgery Receives: Drug: Tylenol |
| Tylenol every 6hrs | Experimental | Tylenol prescribed to be taken very 6 hours for pain management for 48 hours after surgery Receives: Drug: Tylenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent reported Pain score using the Parent's Post-operative Pain Measure
Pain score reported by parent validated questionnaire- Scale from 0 to 29, 0 is no pain and 29 is the worst pain.
Measured: From enrollment to 1 day after surgery
Child reported pain score using the Faces Pain Scale- Revised
Child reported pain using Faces Pain Scale revised questionnaire. Scale from 0 to 5; 0 is no pain and 5 is the worst pain.
Measured: 2-4 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Why it stopped: The protocol needs to be changed before enrolling
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrabismusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hawke H. Yoon, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689943
- Sponsor's protocol ID
- 2024-7067
- Status last verified
- Jul 2026
- First submitted
- 13 Nov 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Walther-Larsen S, Aagaard GB, Friis SM, Petersen T, Moller-Sonnergaard J, Romsing J. Structured intervention for management of pain following day surgery in children. Paediatr Anaesth. 2016 Feb;26(2):151-7. doi: 10.1111/pan.12811. Epub 2015 Nov 12.
PubMed 26559643Vons KM, Bijker JB, Verwijs EW, Majoor MH, de Graaff JC. Postoperative pain during the first week after adenoidectomy and guillotine adenotonsillectomy in children. Paediatr Anaesth. 2014 May;24(5):476-82. doi: 10.1111/pan.12383. Epub 2014 Mar 20.
PubMed 24646093Ghai B, Makkar JK, Wig J. Postoperative pain assessment in preverbal children and children with cognitive impairment. Paediatr Anaesth. 2008 Jun;18(6):462-77. doi: 10.1111/j.1460-9592.2008.02433.x. Epub 2008 Mar 18.
PubMed 18363630de Azevedo CB, Carenzi LR, de Queiroz DL, Anselmo-Lima WT, Valera FC, Tamashiro E. Clinical utility of PPPM and FPS-R to quantify post-tonsillectomy pain in children. Int J Pediatr Otorhinolaryngol. 2014 Feb;78(2):296-9. doi: 10.1016/j.ijporl.2013.11.027. Epub 2013 Dec 1.
PubMed 24370467Chambers CT, Reid GJ, McGrath PJ, Finley GA. Development and preliminary validation of a postoperative pain measure for parents. Pain. 1996 Dec;68(2-3):307-13. doi: 10.1016/s0304-3959(96)03209-5.
PubMed 9121819Chambers CT, Finley AG, McGrath PJ, Walsh TM. The parents' postoperative pain measure: replication and extension to 2-6-year-old children. Pain. 2003 Oct;105(3):437-443. doi: 10.1016/S0304-3959(03)00256-2.
PubMed 14527704
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain After Strabismus Surgery: Post-Operative Outcomes Using Courses of Acetaminophen in Children
- ClinicalTrials.gov ID
- NCT06689943
- Acronym / sponsor ID
- 2024-7067
- Conditions
- Strabismus
- Keywords
- pain, strabismus surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The protocol needs to be changed before enrolling
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Nov 2024 (actual)
- 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.
At Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's), the current practice is to prescribe children with oral Tylenol as needed every 4-6 hours post strabismus surgery. Prescribing Tylenol "as needed" leaves more room for error for parents to be under-dosing their children, which can lead to avoidable pain. This study aims to figure out if children ages 4-12 years old will feel significantly less pain and discomfort when given regimented Tylenol every 6 hours for 48 hours after strabismus surgery (eye muscle surgery) compared to controls whose parents are instructed to give Tylenol every 4-6 hours as needed for 48 hours after surgery. To date, there have been no studies comparing patient outcomes between those taking Tylenol regimen and those receiving Tylenol as needed after pediatric surgery.
Detailed description
Main hypothesis:
Children ages 4-12 years will feel significantly less pain and discomfort when given regimented Tylenol every 6 hours for 48 hours after strabismus surgery (surgery to correct misaligned eyes) compared to controls whose parents are instructed to give Tylenol every 4-6 hours as needed for 48 hours after surgery.
Primary Objective At Lurie Children's, the current standard practice is for patients to be prescribed oral acetaminophen as needed every 4-6 hours after strabismus surgery. However, making the acetaminophen "as needed" leaves room for error for parents to be underdosing their children and, thus, leads to increased pain felt by these pediatric patients. To date, there have been no studies comparing patient satisfaction outcomes between a group taking a course of scheduled acetaminophen every 6 hours and to a group instructed to take as needed. The investigators plan to study the differences between these two groups by using the Parent's Post-operative Pain Measure (PPPM) questionnaire to survey parents and the Faces Pain Scale-Revised to survey children at their post-operative appointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tylenol as needed | Active comparator | Drug: TylenolTylenol prescribed to be taken as needed for pain management for 48 hours after surgery |
| Tylenol every 6hrs | Experimental | Drug: TylenolTylenol prescribed to be taken very 6 hours for pain management for 48 hours after surgery |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 4-12 years old
- Children receiving single muscle, bilateral horizontal strabismus surgery (that is, children who are having only one horizontal eye muscle in each eye operated on) at Lurie Children's hospital in Chicago, IL
- ASA classification 1 or 2. Note: ASA is a physical status classification system (scale of 1-6) created by the American Society of Anesthesiologists to describe patients prior to surgery. ASA 1 or 2 means the patient is either healthy or has mild systemic disease prior to surgery.
Key exclusion criteria (4 listed)
- ASA classification 3 or higher (patient has severe systemic disease or worse)
- Contraindication to toradol (anesthesia)
- Contraindication to acetaminophen
- Previous strabismus surgery
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 |
|---|---|---|
| TylenolAlso: acetaminophenTylenol for children | Drug | Tylenol as needed, Tylenol every 6hrs |
Primary outcome
Parent reported Pain score using the Parent's Post-operative Pain Measure
Time frame: From enrollment to 1 day after surgery
Pain score reported by parent validated questionnaire- Scale from 0 to 29, 0 is no pain and 29 is the worst pain.
Child reported pain score using the Faces Pain Scale- Revised
Time frame: 2-4 days after surgery
Child reported pain using Faces Pain Scale revised questionnaire. Scale from 0 to 5; 0 is no pain and 5 is the worst pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 26559643Walther-Larsen S, Aagaard GB, Friis SM, Petersen T, Moller-Sonnergaard J, Romsing J. Structured intervention for management of pain following day surgery in children. Paediatr Anaesth. 2016 Feb;26(2):151-7. doi: 10.1111/pan.12811. Epub 2015 Nov 12.
- Background: PubMed 24646093Vons KM, Bijker JB, Verwijs EW, Majoor MH, de Graaff JC. Postoperative pain during the first week after adenoidectomy and guillotine adenotonsillectomy in children. Paediatr Anaesth. 2014 May;24(5):476-82. doi: 10.1111/pan.12383. Epub 2014 Mar 20.
- Background: PubMed 18363630Ghai B, Makkar JK, Wig J. Postoperative pain assessment in preverbal children and children with cognitive impairment. Paediatr Anaesth. 2008 Jun;18(6):462-77. doi: 10.1111/j.1460-9592.2008.02433.x. Epub 2008 Mar 18.
- Background: PubMed 24370467de Azevedo CB, Carenzi LR, de Queiroz DL, Anselmo-Lima WT, Valera FC, Tamashiro E. Clinical utility of PPPM and FPS-R to quantify post-tonsillectomy pain in children. Int J Pediatr Otorhinolaryngol. 2014 Feb;78(2):296-9. doi: 10.1016/j.ijporl.2013.11.027. Epub 2013 Dec 1.
- Background: PubMed 9121819Chambers CT, Reid GJ, McGrath PJ, Finley GA. Development and preliminary validation of a postoperative pain measure for parents. Pain. 1996 Dec;68(2-3):307-13. doi: 10.1016/s0304-3959(96)03209-5.
- Background: PubMed 14527704Chambers CT, Finley AG, McGrath PJ, Walsh TM. The parents' postoperative pain measure: replication and extension to 2-6-year-old children. Pain. 2003 Oct;105(3):437-443. doi: 10.1016/S0304-3959(03)00256-2.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tylenol in people with Strabismus, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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 3 inclusion and 4 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: paused, as of the sponsor's last update on 30 Jul 2026. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent reported Pain score using the Parent's Post-operative Pain Measure (time frame: From enrollment to 1 day after surgery). The study lists 2 primary outcomes in all. 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 NCT06689943, which also lists 6 linked publications.
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 30 Jul 2026.