Ketorolac in Palatoplasty
ConditionCleft Lip and Palate
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6+
SponsorThe University of Texas Health Science Center, Houston
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Syndromic Cleft Palate patients
Previous palatoplasty
Major unrepaired cardiac malformation
History of GI complications (GI Bleed, Gastric Ulceration)
Trial design
Design model
Parallel
Treatments tested in this trial
Ketorolac
DrugKetorolac 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
Drug0.9% 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.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Experimental group (Ketorolac)Experimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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 PACU2
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 surgery3
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 surgery4
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 dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov