A Phase 4 interventional study of Ketorolac and Placebo in Cleft Lip and Palate, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment
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
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 74 is above the median of 30 across 116 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Ketorolac
Drug: Placebo
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
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.
Volume of oral intake
This will be measured in mL's of fluids
Time frame: from arrival to Post-Anesthesia Care Unit (PACU) to 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
Time frame: immediately upon arrival at PACU
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
Time frame: 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
Time frame: 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
Time frame: 7 days post discharge
Time to first oral intake
Time frame: within 24 hours post surgery
Number of participants with Post-operative bleeding that requires either transfusion or Unplanned return to Operating Room
Time frame: 24 hours and 48 hours after surgery
Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents)
Time frame: 7 days post surgery
Number of participants who need narcotic prescription at discharge
Time frame: at discharge(24-48 hours post surgery)
Renal function measured in mL/kg of urine output
Time frame: 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
Time frame: 30 days post surgery
Plan to share: No
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Studies of the drug tested here: Ketorolac
The University of Texas Health Science Center, Houston →