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NCT Number: NCT04771156

Ketorolac in Palatoplasty

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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Key information

Conditions

Cleft Lip and Palate Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Matthew R Greives, MD,MS,FACS

CONTACT

[email protected]

713-500-7275

Tien Do, DO

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral

Exclusion criteria

  • 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

Treatment and study plan

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

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale

    Time frame: immediately upon arrival at PACU

    This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome

  2. Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale

    Time frame: 24 hours post surgery

    This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome

  3. Pain as assessed by the Faces, Legs, Activity, Cry, Consolability (FLACC) scale

    Time frame: 48 hours post surgery

    This scale has 5 questions and each is scored from 0-2,higher number indicating a worse outcome

  4. Pain as assessed by the Faces scale

    Time frame: 7 days post discharge

    Subjective assessment of discomfort by parent, scored from 1-10, higher number indicating a worse outcome

  5. Time to first oral intake

    Time frame: within 24 hours post surgery

  6. 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

  7. Amount of Post-operative narcotic usage (recorded in Morphine milligram Equivalents)

    Time frame: 7 days post surgery

  8. Number of participants who need narcotic prescription at discharge

    Time frame: at discharge(24-48 hours post surgery)

  9. Renal function measured in mL/kg of urine output

    Time frame: from arrival to PACU to discharge (24-48 hours post surgery)

  10. Number of participants with post operative complications

    Time frame: 30 days post surgery

    post operative complications include,Unplanned return to OR, ER or unplanned clinic visit , Infection, Fever

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew R Greives, MD,MS,FACS

CONTACT

[email protected]

(713) 500-7275

Tien Do, DO

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2021
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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