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The purpose of this study is to see if the addition of IV Ketorolac to usual care multi-modal pain therapy compared to usual care will improve oral intake post-operatively
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group (Ketorolac) | Experimental |
| |
| Control Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | Ketorolac 0.5mg/kg will be administered intra-operatively at the conclusion of the case and 3 more doses scheduled every 8 hours in the first 24 hours post-operatively for a total of 4 doses of Ketorolac |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of oral intake | This will be measured in mL's of fluids | from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale | This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome | immediately upon arrival at PACU |
| Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale |
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Inclusion Criteria:
-Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew R Greives, MD,MS,FACS | Contact | (713) 500-7275 | Matthew.R.Greives@uth.tmc.edu | |
| Tien Do, DO | Contact | Tien.Do@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matthew R Grieves, MD,MS,FACS | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | 0.9% Normal Saline will be administered intra-operatively at the conclusion of the case and 3 more doses scheduled every 8 hours in the first 24 hours post-operatively for a total of 4 doses of normal saline. |
|
This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome |
| 24 hours post surgery |
| Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale | This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome | 48 hours post surgery |
| Pain as assessed by the Faces scale | Subjective assessment of discomfort by parent, scored from 1-10, higher number indicating a worse outcome | 7 days post discharge |
| Time to first oral intake | within 24 hours post surgery |
| Number of participants with Post-operative bleeding that requires either transfusion or Unplanned return to Operating Room | 24 hours and 48 hours after surgery |
| Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents) | 7 days post surgery |
| Number of participants who need narcotic prescription at discharge | at discharge(24-48 hours post surgery) |
| Renal function measured in mL/kg of urine output | from arrival to PACU to discharge (24-48 hours post surgery) |
| Number of participants with post operative complications | post operative complications include,Unplanned return to OR, ER or unplanned clinic visit , Infection, Fever | 30 days post surgery |
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006571 | Heterocyclic Compounds |