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Analgesic

Tylenol every 6hrs for Strabismus

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
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to 1 day after surgery
Awards & highlights
No Placebo-Only Group

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. 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.

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

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%
Urinary tract infection
25%
Fever
25%
Dizziness
25%
Hypoalbuminemia
25%
Abdominal pain
25%
Lipase increased
25%
Pain
25%
Urinary incontinence
25%
Urinary retention
25%
Creatinine increased
25%
Constipation
25%
Upper respiratory infection
17%
Nasal congestion
17%
Blurred vision
17%
Proteinuria
17%
Hyperkalemia
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%
Nausea
17%
Serum amylase increased
17%
Muscle weakness lower limb
17%
Urinary frequency
8%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
8%
Infections and infestations - Other, Herpes simplex reactivation
8%
Injury, poisoning and procedural complications - Other, Abrasions left hand
8%
Surgical and medical procedures - Other, Bilateral stent placements
8%
Surgical and medical procedures - Other, rt nephro-ureterostomy tube exchange
8%
Nystagmus
8%
Hypermagnesemia
8%
Blood and lymphatic system disorders - Other, Thrombocytopenia
8%
General disorders and administration site conditions - Other, retching, gagging
8%
Skin and subcutaneous tissue disorders - Other, Right groin incision disorder
8%
Skin and subcutaneous tissue disorders - Other, skin rash eyes area and hands
8%
Blood bilirubin increased
8%
Conjunctivitis
8%
Gastrointestinal disorders - Other, degenerative teeth 22&27
8%
Eye disorders - Other, Blepharitis
8%
Colitis
8%
Dehydration
8%
Non-cardiac chest pain
8%
CPK increased
8%
Breast pain
8%
Jejunal obstruction
8%
Adrenal insufficiency
8%
Skin infection
8%
Photophobia
8%
Injury, poisoning and procedural complications - Other, Mild head injury (hit his head)
8%
Skin and subcutaneous tissue disorders - Other, specify
8%
Generalized muscle weakness
8%
Cystitis noninfective
8%
Hypomagnesemia
8%
Nervous system disorders - Other, lightness - positional standing up
8%
Myocarditis
8%
Kidney infection
8%
Hypernatremia
8%
Hypothyroidism
8%
Pruritus
8%
Urinary tract obstruction
8%
Chest pain - cardiac
8%
Blood and lymphatic system disorders - Other, Amylase increased
8%
General disorders and administration site conditions - Other, sweating intermittent
8%
Vomiting
8%
Respiratory, thoracic and mediastinal disorders - Other, shortness of breath
8%
Surgical and medical procedures - Other, Ultrasound guided percutaneous drain for findings of left
8%
Dyspnea
8%
Hypertension
8%
Gastrointestinal disorders - Other, Polydipsia
8%
Respiratory, thoracic and mediastinal disorders - Other, Cold symptoms
8%
GGT increased
8%
Vestibular disorder
8%
Hematuria
8%
Hypoglycemia
8%
Surgical and medical procedures - Other, Esophagogastroduodenoscopy
8%
Hypotension
8%
Glaucoma
8%
Gynecomastia
8%
Hypoxia
8%
Infections and infestations - Other, Viral Infection
8%
Memory impairment
8%
Mucositis oral
8%
Pain in extremity
8%
Platelet count decreased
8%
Sinus bradycardia
8%
Tooth infection
8%
Renal and urinary disorders - Other, UTI
8%
Surgical and medical procedures - Other, BL ureteral stent exchanges- Annual
8%
Flank pain
8%
Surgical and medical procedures - Other, Positive Cologuard test
8%
Hyperthyroidism
8%
Myositis
8%
Bruising
8%
Dry skin
8%
Metabolism and nutrition disorders - Other, Poor appetite
8%
Surgical and medical procedures - Other, left percutaneous nephrostomy
8%
Back pain
8%
Duodenal obstruction
8%
Lung infection
8%
Confusion
8%
Dry eye
8%
Flu like symptoms
8%
Sinus tachycardia
8%
Weight loss
8%
Renal and urinary disorders - Other, Pyelonephritis
8%
Cataract
8%
Surgical and medical procedures - Other, Small bowel resection
8%
Uveitis
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
265 Previous Clinical Trials
5,182,622 Total Patients Enrolled
~53 spots leftby Dec 2028
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