anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Rocuronium
Trial phase: Not Applicable
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Rocuronium dose 0.4 mg/kg
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesia (ASA) physical status class I or II.
Body mass index between 18 and 35 kg m-2.
No use of psychotropic or neuropsychiatric medications.
A airway assessment with no indication of a difficult intubation including a class I or II Mallampati airway and a mandible-to-hyoid distance of greater than three fingerbreadths.
Age between 18-75 years.

Exclusion Criteria:

Does not meet inclusion criteria.
Intervention: Rocuronium
Trial phase: Not Applicable
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Rocuronium dose 0.6 mg/kg
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesia (ASA) physical status class I or II.
Body mass index between 18 and 35 kg m-2.
No use of psychotropic or neuropsychiatric medications.
A airway assessment with no indication of a difficult intubation including a class I or II Mallampati airway and a mandible-to-hyoid distance of greater than three fingerbreadths.
Age between 18-75 years.

Exclusion Criteria:

Does not meet inclusion criteria.
Intervention: Loteprednol etabonate/tobramycin
Trial phase: Phase 4
SMILES: CCOC(=O)OC1(C(=O)OCCl)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C.NCC1OC(OC2C(N)CC(N)C(OC3OC(CO)C(O)C(N)C3O)C2O)C(N)CC1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling). Tobramycin is an antibiotic.

Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female
At least 18 years of age
Has not worn contact lenses, except for bandage contact lens or rigid gas permeable lens, for at least 2 weeks prior to the study and agrees to not wear contact lenses during study
Patient is in generally good & stable overall health
Minimum corneal fluorescein staining of 4 in at least one eye
OSDI score >22
The patient must have a diagnosis of posterior blepharitis
A negative urine pregnancy test result for women of childbearing potential
Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
Normal lid position and closure
Ability to understand and provide informed consent to participate in this study
Willingness to follow study instructions and likely to complete all required visits

Exclusion Criteria:

History of Stevens-Johnson syndrome or ocular pemphigoid
History of eyelid surgery
Intra-ocular surgery or ocular laser surgery within 3 months
History of microbial keratitis, including herpes
Active ocular allergies
Corneal epithelial defect > 1mm2
Any change in use of topical anti-inflammatories, such as steroids, Restasis, or NSAID within the past 2 weeks
Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the past two weeks
Use of isotretinoin (Accutane) within the past 6 months
Pregnant or lactating women
Signs of current infection, including fever and current treatment with antibiotics
Active liver, renal, or hematologic disease
The use of any other investigational drug
Individuals with a known history of glaucoma, individuals with IOP >22 Hg in either eye and individuals with a known family history of glaucoma in primary (first degree) relatives (ie. mother, father, sibling or child)
Intervention: Amiodarone
Trial phase: Phase 4
ATC code: C01BD01
SMILES: CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: standard dose amiodarone

amiodarone: standard dose amiodarone
Eligibility criteria:
Inclusion Criteria:

new onset afib

Exclusion Criteria:

hemodynamically unstable
Intervention: Tetracycline
Trial phase: Phase 2
ATC code: A01AB13 | A02BD02 | A02BD08 | D06AA04 | J01AA07 | J01AA20 | J01RA08 | S01AA09 | S02AA08 | S03AA02
SMILES: [H][C@]12C[C@@]3([H])[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]3(O)C(O)=C1C(=O)c1c(O)cccc1[C@@]2(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: No adverse events were reported in any subjects who were taking minocycline. All subjects underwent monthly blood tests to monitor alanine transaminase and blood urea nitrogen levels.
Eligibility criteria:
Inclusion Criteria:

Cognitively normal elderly subjects between the ages of 55-90 and patients aged 55 - 90 years who have mild cognitive impairment (MCI) or clinically defined Alzheimer's disease.

Exclusion Criteria:

Any person with medical devices such as cardiac pacemakers/defibrillators or neuro-implants as they are contra-indications for MRI/MRS exam.
Since the effects of MRI are unknown to the fetus or unborn child, any person who is or may be pregnant will be excluded from the study.
History of known allergy or intolerance to minocycline or any other tetracycline
Impaired renal function (plasma Creatinine) or blood urea nitrogen (BUN) levels exceeds twice normal upper limit which can result in higher serum levels of tetracycline, azotemia, hyperphosphatemia and acidosis.
Intervention: Nacom
Trial phase: Not Applicable
SMILES: CC(Cc1ccc(O)c(O)c1)(NN)C(=O)O.NC(Cc1ccc(O)c(O)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Sinemet CR

Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year
Eligibility criteria:
Inclusion Criteria:

idiopathic Parkinson's disease meeting United Kingdom (UK) brain bank criteria
De Novo
Hoehn&Yahr staging (H&Y) I-II

Exclusion Criteria:

Atypical Parkinsonism
Pregnant or breast-feeding women
those with abnormal Liver/kidney function
those participating other clinical trials within 30 days before being enrolled for this trial.
Intervention: Aclidinium Bromide
Trial phase: Phase 3
ATC code: R03AL05
SMILES: O=C(OC1C[N+]2(CCCOc3ccccc3)CCC1CC2)C(O)(c1cccs1)c1cccs1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Adult male and female patients aged ≥ 40 with stable moderate to severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).
Post-salbutamol Forced Expiratory Volume in one second(FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) < 70%.
Current or ex-smokers of ≥ 10 pack-years
Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value

Exclusion Criteria:

History or current diagnosis of asthma
Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Patients with an oxygen saturation < 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1.
Contra-indications of cardiopulmonary exercise testing.
Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.
Intervention: Vemurafenib
Trial phase: Phase 2
ATC code: G01AE10 | L01EC01 | L01XE15
SMILES: CCCS(=O)(=O)Nc1ccc(F)c(C(=O)c2c[nH]c3ncc(-c4ccc(Cl)cc4)cc23)c1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.

Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.
Eligibility criteria:
Inclusion Criteria:

Age >18 years old.
Histologic proof of melanoma reviewed and confirmed by MSKCC.
A confirmed EBRAFV600E or KBRAFV600K mutation.
Stage IV melanoma, or advanced stage III not curable by surgery. Patients with active CNS metastases will be allowed on the study.
Measurable disease by RECIST v1.1.
ECOG performance status 3 or 4. The basis for the grading of performance is strict; there must be clear justification of the performance status grade (e.g. patient is confined to bed > 50% of time, or cannot carry out ADLs, or is otherwise disabled by burden of disease such as requiring supplemental O2).
Patients must be able to swallow pills
Adequate hematologic, hepatic and renal function as defined by the following:
Absolute Neutrophil Count ≥ 1.0 x 109/L
Hemoglobin ≥8.0g/dL, occasional transfusions are acceptable as vemurafenib does not have significant hematologic toxicities.
Total bilirubin ≤2.0x the upper limit of normal, ≤3.0x the upper limit of normal if the patient has Gilbert's Syndrome.
Alkaline phosphatase ≤2.0x the upper limit of normal.
AST and ALT ≤2.0x the upper limit of normal.
Serum creatinine ≤ 1.5x the upper limit of normal.

Exclusion Criteria:

Uveal melanoma as primary.
Concurrent chemotherapy, immunotherapy, or radiotherapy.
Prior treatment with a RAF inhibitor. Other prior chemotherapy, immunotherapy, or radiotherapy will be allowed including prior treatment with a MEK inhibitor Patients must have had complete recovery from any adverse events or toxicities of prior cancer-directed therapies.
Pregnant or lactating women.
A second active malignancy. Prior malignancy will be allowed as long as the patient is known to be free of disease for at least 2 years. Patients with indolent B-cell malignancies will not be eligible.
QTc interval > 500 msec.
Intervention: Dalcetrapib
Trial phase: Phase 1
SMILES: CCC(CC)CC1(C(=O)Nc2ccccc2SC(=O)C(C)C)CCCCC1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: dalcetrapib: Single oral radiolabeled dose
Eligibility criteria:
Inclusion Criteria:

Healthy male subjects, 45 to 65 years of age inclusive
Body mass index (BMI) between 18 and 32 kg/m2 inclusive

Exclusion Criteria:

Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the subject
Clinically significant abnormal laboratory values
Infrequent bowel movements (e.g. less than one movement per 24 h on average)
An intent to father children within 3 months of dosing
Any external or internal radiotherapy with open (nuclear medicine) or sealed sources (brachy therapy)
External irradiation (radiological examination) or internal radiation (diagnostic nuclear medicine procedure) within one year before study drug dosing; dental radiography and plain X-rays of the extremities are allowed before dosing
Intervention: Metformin
Trial phase: Phase 3
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 219
Group description: Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily

Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group
Eligibility criteria:
Inclusion Criteria:

Type 1 Diabetes for five years or more*
Age 40 years or above
7.0 =< HbA1c <10.0% (53 - 86 mmol/mol)

AND 3 or more of the following ten CardioVascular Disease (CVD) risk factors:

BMI >27 kg/m^2
Current HbA1c >8.0% (64 mmol/mol)
Known CVD/peripheral vascular disease
Current smoker
Estimated glomerular filtration rate (eGFR) <90 ml/min per 1.73 m^3
Confirmed micro- or macroalbuminuria [according to local assays and reference ranges]
Hypertension (BP >=140/90 millimeters of mercury (mmHg) or established on antihypertensive treatment)
Dyslipidaemia [total cholesterol >=5.0 mmol/L (200 mg/dL);OR HDL cholesterol <1.20 mmol/L (46mg/dL) [MEN]; OR <1.30 mmol/L (50 mg/dL) [WOMEN]; or triglycerides >=1.7 mmol/L (150mg/dL); or established on lipid-lowering treatment)]
Strong family history of CVD (at least one parent, biological aunt/ uncle, or sibling with myocardial infarction or stroke aged <60 years)
Duration of diabetes > 20 years

Exclusion Criteria:

eGFR < 45 ml/min/1.73m2
woman of childbearing age not on effective contraception
Pregnancy and/or lactation
Acute coronary syndrome or Stroke/Transient Ischaemic Attack within the last three months
NYHA stage 3 or 4 heart failure
Significant hypoglycaemia unawareness
Impaired cognitive function/ unable to give informed consent
Previous carotid surgery/ inability to capture adequate carotid images
Estimated glomerular filtration < 45ml/min/1.73m^2 (MDRD)
Gastroparesis
History of lactic acidosis
Other contraindications to metformin (hepatic impairment, known hypersensitivity to metformin, acute illness such as dehydration, severe infection, shock, acute cardiac failure or suspected tissue hypoxia)
Any coexistent life threatening condition including prior diagnosis of cancer within two years
History of alcohol problem or drug abuse
Intervention: Metformin
Trial phase: Not Applicable
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Patients receiving metformin and insulin therapy.
Eligibility criteria:
Inclusion Criteria:

ALL patients on induction chemotherapy who develop transient hyperglycemia(definition of transient hyperglycemia: random blood glucose > 200 mg/dL x 2)
Adequate renal function (serum Cr < 1.5 mg/dL in males, < 1.2 mg/dL in females)
Adequate hepatic function (AST < 5x upper limit of normal)

Exclusion Criteria:

Patients with known diagnosis of diabetes or those that are already on oral hypoglycemic agents or insulin
Allergy to metformin or any component of the formulation
Patients with pancreatitis (lipase level > 300 Units/L)
Patients with active infection (positive blood culture within 48 hours of study registration)
Patients with hemodynamic instability (PICU status, need for vasopressors within 48 hours of study entry)
Elevated hemoglobin A1c (greater than 6.0%)
Intervention: Cisplatin
Trial phase: Phase 3
ATC code: L01XA01
SMILES: Cl[Pt]Cl.N.N
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Subjects with limited stage SCLC treated sequentially with cisplatin.

Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies
Eligibility criteria:
Inclusion Criteria: Competent adult English speaking subjects

With limited stage SCLC who have completed standard of care treatment who are responders with no evidence of disseminated disease other than CNS metastasis,
With recurrent disseminated SCLC after standard of care treatment with symptoms related to central tumor obstruction,
With recurrent limited stage SCLC with mediastinal/hilar recurrence not previously treated with intratumoral cisplatin

Exclusion Criteria:

Subjects who do not meet the inclusion criteria
Subjects who, in the opinion of the investigator, are at risk undergoing a bronchoscopy
Intervention: Perflutren
Trial phase: Phase 4
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 219
Group description: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)

3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)
Eligibility criteria:
Inclusion Criteria:

Be a female diagnosed by x-ray mammography (performed within 90 days prior to the study procedure) as having a solid breast mass or abnormal area without a mass.
Be scheduled for a biopsy (core / excisional / lumpectomy) of the mass or region of abnormality or for mastectomy within 30 days after this study procedure.
Be at least 18 years of age.
Be medically stable.
If a female of child-bearing potential, must have a negative pregnancy test.
Have signed Informed Consent to participate in the study.

Exclusion Criteria:

Males
Females who are pregnant or nursing.
Patients whose breast lesion is unequivocally a cyst by unenhanced US.
Patients currently on chemotherapy or with other primary cancers requiring systemic treatment.
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
Patients on life support or in a critical care unit.
Patients with unstable occlusive disease (eg, crescendo angina)
Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
Patients with uncontrolled congestive heart failure (NYHA Class IV)
Patients with recent cerebral hemorrhage.
Patients with clinically significant and unstable renal and/or liver disease (eg, transplant recipients in rejection)
Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
Patients with known hypersensitivity to perflutren
Patients who have received any contrast medium (X-ray, MRI, CT, of US) in the 24 hours prior to the research US exam
Patients with cardiac shunts.
Patients with congenital heart defects.
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.
Patients with confirmed or suspected liver lesions.
Patients with respiratory distress syndrome.
Patients who have had excisional biopsy/lumpectomy of the current area of interest within the past 6 weeks.
Intervention: Latanoprost
Trial phase: Phase 2
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: One drop at 8.00pm.
Eligibility criteria:
Inclusion Criteria:

Untreated bilateral newly diagnosed patients with primary open angle glaucoma

Exclusion Criteria:

Any ocular hypertension other than chronic open angle glaucoma
Intervention: Fingolimod
Trial phase: Phase 3
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 162
Group description: Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
Eligibility criteria:
Inclusion Criteria:

Patients with relapsing remitting Multiple Sclerosis
Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.

Exclusion Criteria:

Patients with MS other than relapsing remitting MS
Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.

Patients who have been treated with:

systemic corticosteroids or immunoglobulins within 1 month prior to baseline;
immunosuppressive medications within 3 months prior to baseline;
monoclonal antibodies within 3 months prior to baseline;
cladribine, mitoxantrone or alemtuzumab at any time.
Uncontrolled diabetes mellitus at screening
Diagnosis of macular edema during Screening Phase
Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
Patients who have received total lymphoid irradiation or bone marrow transplantation.
Patients with certain cardiovascular conditions and/or findings in the screening ECG
Patients with certain liver conditions
Pregnant confirmed by a positive pregnancy test t or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Fingolimod
Trial phase: Phase 3
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
Eligibility criteria:
Inclusion Criteria:

Patients must:

Have relapsing remitting multiple sclerosis
Have been on treatment with natalizumab for at least 6 months prior to screening and discontinuation is an option.

Exclusion Criteria:

Patients with:

History of chronic immune disease
Crohn's disease
Certain cancers
Uncontrolled diabetes
Certain eye disorders
Negative for varicella-zoster virus IgG antibodies
Certain hepatic conditions
Low white blood cell count
On certain immunosuppressive medications or heart medications
Resting heart rate less than 45 bpm.
Certain heart conditions or certain lung conditions
Inability to undergo MRI scans

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 45
Group description: Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.

Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c
Eligibility criteria:
Inclusion Criteria:

Children 5 months to five years of age
ASA physical status I or II
primary cleft palate repair alone or in some combination with bilateral myringotomy with tympanostomy (BMT), alveoplasty, vomer flap, rhinoplasty, and or cleft lip repair.?

Exclusion Criteria:

Repeat/revision cleft palate repair
Contraindications to acetaminophen administration (liver or renal dysfunction, allergy)
Chronic pain medications
Diagnosis of chronic pain syndrome
Contraindications to morphine (renal impairment, allergy)
Seizure disorders and/or taking anti-seizure medications
Contraindications to oral midazolam (liver dysfunction, allergy)
Allergy to local anesthetics