Cleft Lip and PalatePhase 4NCT04771156
Ketorolac in Palatoplasty
A Phase 4 study testing Ketorolac in people with Cleft Lip and Palate, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Ketorolac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2021to 1 Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral
Who cannot join
- Syndromic Cleft Palate patients
- Previous palatoplasty
- Major unrepaired cardiac malformation
- History of GI complications (GI Bleed, Gastric Ulceration)
- History of Renal disorder
- History of coagulopathy (As contraindication to NSAID use)
- Feeding tube dependency
- Patients whose parents refuse to consent to randomization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tien Do, DO contact
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Matthew R Greives, MD,MS,FACS, 713-500-7275, Matthew.R.Greives@uth.tmc.edu
Tien Do, DO, Tien.Do@uth.tmc.edu
About this study
Official title: Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.
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
- Conditions
- Cleft Lip and Palate
- Being tested
- Ketorolac, Placebo
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
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
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (Ketorolac) | Experimental | Not described Receives: Drug: Ketorolac |
| Control Group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of oral intake
This will be measured in mL's of fluids
Measured: from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 7 days post discharge
Time to first oral intake
Measured: within 24 hours post surgery
Number of participants with Post-operative bleeding that requires either transfusion or Unplanned return to Operating Room
Measured: 24 hours and 48 hours after surgery
Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents)
Measured: 7 days post surgery
Number of participants who need narcotic prescription at discharge
Measured: at discharge(24-48 hours post surgery)
Renal function measured in mL/kg of urine output
Measured: 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
Measured: 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start17 Sep 2021
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Greives, The University of Texas Health Science Center, Houston
- Investigators
- Matthew R Grieves, MD,MS,FACS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771156
- Sponsor's protocol ID
- HSC-MS-21-0044
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2021
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.
- ClinicalTrials.gov ID
- NCT04771156
- Acronym / sponsor ID
- HSC-MS-21-0044
- Conditions
- Cleft Lip and Palate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (Ketorolac) | Experimental | Drug: Ketorolac |
| Control Group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral
Key exclusion criteria (8 listed)
- Syndromic Cleft Palate patients
- Previous palatoplasty
- Major unrepaired cardiac malformation
- History of GI complications (GI Bleed, Gastric Ulceration)
- History of Renal disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacKetorolac 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 | Drug | Experimental group (Ketorolac) |
| Placebo0.9% 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. | Drug | Control Group |
Primary outcome
Volume of oral intake
Time frame: from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery
This will be measured in mL's of fluids
10 secondary outcomes
Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
Time frame: immediately upon arrival at PACU
Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
Time frame: 24 hours post surgery
Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale
Time frame: 48 hours post surgery
Pain as assessed by the Faces scale
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
Time frame: 30 days post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tien Do, DO contact
Matthew R Grieves, MD,MS,FACS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac in people with Cleft Lip and Palate, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew R Greives, MD,MS,FACS ((713) 500-7275, Matthew.R.Greives@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of oral intake (time frame: from arrival to Post-Anesthesia Care Unit (PACU) to 24 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.