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Analgesic

Tylenol for Pain After Crossed Eyes Surgery

Phase 2
Waitlist Available
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ASA classification 1 or 2 (healthy or mild systemic disease)
Children receiving single muscle, bilateral horizontal strabismus surgery at Lurie Children's hospital in Chicago, IL
Must not have
Previous strabismus surgery
Contraindication to acetaminophen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to 1 day after surgery
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if children ages 4-12 will have less pain after eye muscle surgery when given Tylenol every 6 hours for 48 hours compared to those given Tylenol

Who is the study for?
This trial is for children aged 4-12 who have undergone strabismus surgery at Lurie Children's Hospital. The study is designed to see if a regular schedule of Tylenol reduces pain better than giving it 'as needed'. Specific eligibility criteria are not provided, but typically would include good health status and no allergies to Tylenol.
What is being tested?
The study tests whether taking Tylenol on a fixed schedule (every 6 hours) for two days after eye muscle surgery leads to less pain compared to when it's given based on parents' judgment of their child's pain levels ('as needed').
What are the potential side effects?
Tylenol is generally safe but can cause side effects like nausea, stomach pain, loss of appetite, itching, rash or headache. Overdosing can lead to severe liver damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am generally healthy or have a mild health condition.
Select...
My child is having eye muscle surgery for crossed eyes at Lurie Children's Hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery for crossed eyes before.
Select...
I cannot take acetaminophen due to health reasons.
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I have a severe systemic disease.
Select...
I cannot take toradol due to an adverse reaction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to 1 day after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 1 day after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Child reported pain score using the Faces Pain Scale- Revised
Parent reported Pain score using the Parent's Post-operative Pain Measure

Side effects data

From 2023 Phase 1 & 2 trial • 24 Patients • NCT02933255
100%
Injection site reaction
58%
Fatigue
50%
Hyperglycemia
42%
Alanine aminotransferase increased
42%
Aspartate aminotransferase increased
33%
Anemia
33%
Cough
33%
Headache
33%
Myalgia
33%
Rash acneiform
33%
Fall
33%
Hypophosphatemia
25%
Fever
25%
Dizziness
25%
Hypoalbuminemia
25%
Abdominal pain
25%
Lipase increased
25%
Pain
25%
Urinary incontinence
25%
Urinary retention
25%
Urinary tract infection
25%
Constipation
25%
Creatinine increased
25%
Upper respiratory infection
17%
Blurred vision
17%
Hyperkalemia
17%
Nausea
17%
Proteinuria
17%
Anorexia
17%
Diarrhea
17%
Gait disturbance
17%
Rash maculo-papular
17%
Edema limbs
17%
Insomnia
17%
Lymphocyte count decreased
17%
Alkaline phosphatase increased
17%
Muscle weakness lower limb
17%
Serum amylase increased
17%
Urinary frequency
17%
Nasal congestion
8%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
8%
Skin and subcutaneous tissue disorders - Other, skin rash eyes area and hands
8%
Surgical and medical procedures - Other, Ultrasound guided percutaneous drain for findings of left
8%
Jejunal obstruction
8%
Sinus bradycardia
8%
General disorders and administration site conditions - Other, retching, gagging
8%
General disorders and administration site conditions - Other, sweating intermittent
8%
Dyspnea
8%
Nystagmus
8%
Surgical and medical procedures - Other, left percutaneous nephrostomy
8%
CPK increased
8%
Blood and lymphatic system disorders - Other, Thrombocytopenia
8%
Hypoglycemia
8%
Injury, poisoning and procedural complications - Other, Abrasions left hand
8%
Injury, poisoning and procedural complications - Other, Mild head injury (hit his head)
8%
Metabolism and nutrition disorders - Other, Poor appetite
8%
Blood bilirubin increased
8%
Conjunctivitis
8%
Skin and subcutaneous tissue disorders - Other, specify
8%
Surgical and medical procedures - Other, BL ureteral stent exchanges- Annual
8%
Hypermagnesemia
8%
Surgical and medical procedures - Other, rt nephro-ureterostomy tube exchange
8%
Surgical and medical procedures - Other, Positive Cologuard test
8%
Eye disorders - Other, Blepharitis
8%
Dehydration
8%
Non-cardiac chest pain
8%
Tooth infection
8%
Colitis
8%
Breast pain
8%
Adrenal insufficiency
8%
Skin infection
8%
Photophobia
8%
Infections and infestations - Other, Herpes simplex reactivation
8%
Generalized muscle weakness
8%
Cystitis noninfective
8%
Hypomagnesemia
8%
Myocarditis
8%
Kidney infection
8%
Hypernatremia
8%
Hypothyroidism
8%
Pruritus
8%
Urinary tract obstruction
8%
Chest pain - cardiac
8%
Dry skin
8%
Vomiting
8%
Nervous system disorders - Other, lightness - positional standing up
8%
Renal and urinary disorders - Other, Pyelonephritis
8%
Flu like symptoms
8%
Respiratory, thoracic and mediastinal disorders - Other, Cold symptoms
8%
Hypertension
8%
GGT increased
8%
Vestibular disorder
8%
Hematuria
8%
Hypotension
8%
Glaucoma
8%
Gynecomastia
8%
Hypoxia
8%
Memory impairment
8%
Mucositis oral
8%
Renal and urinary disorders - Other, UTI
8%
Myositis
8%
Respiratory, thoracic and mediastinal disorders - Other, shortness of breath
8%
Gastrointestinal disorders - Other, Polydipsia
8%
Infections and infestations - Other, Viral Infection
8%
Pain in extremity
8%
Surgical and medical procedures - Other, Bilateral stent placements
8%
Hyperthyroidism
8%
Back pain
8%
Duodenal obstruction
8%
Lung infection
8%
Confusion
8%
Dry eye
8%
Sinus tachycardia
8%
Weight loss
8%
Bruising
8%
Flank pain
8%
Blood and lymphatic system disorders - Other, Amylase increased
8%
Gastrointestinal disorders - Other, degenerative teeth 22&27
8%
Platelet count decreased
8%
Cataract
8%
Surgical and medical procedures - Other, Small bowel resection
8%
Uveitis
8%
Skin and subcutaneous tissue disorders - Other, Right groin incision disorder
8%
Surgical and medical procedures - Other, Esophagogastroduodenoscopy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lead-in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Cohort
Neoadjuvant Cohort

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tylenol every 6hrsExperimental Treatment1 Intervention
Tylenol prescribed to be taken very 6 hours for pain management for 48 hours after surgery
Group II: Tylenol as neededActive Control1 Intervention
Tylenol prescribed to be taken as needed for pain management for 48 hours after surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tylenol
2019
Completed Phase 4
~520

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
273 Previous Clinical Trials
5,185,493 Total Patients Enrolled
~53 spots leftby Dec 2028
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