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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01500109
Other study ID # 5110257
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2011
Est. completion date August 2014

Study information

Verified date June 2021
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this investigator-initiated study is to determine whether acetaminophen is an effective pain reliever for primary cleft palate repair in children and possesses opioid sparing effects. Additionally, the investigators will determine if patients who receive acetaminophen have less opioid related side-effects. The study will have three study groups based on whether the patient receives Ofirmev® and opioids (Fentanyl and Morphine), oral acetaminophen elixir and opioids (Fentanyl and Morphine), or opioids (Fentanyl and Morphine) alone. Total opioid (Fentanyl and Morphine) consumption will be tracked for the intraoperative period and 24 hours after surgery for all patients within the study and converted to morphine equivalents.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group 5 Months to 5 Years
Eligibility Inclusion Criteria: - Children 5 months to five years of age - ASA physical status I or II - primary cleft palate repair alone or in some combination with bilateral myringotomy with tympanostomy (BMT), alveoplasty, vomer flap, rhinoplasty, and or cleft lip repair.? Exclusion Criteria: - Repeat/revision cleft palate repair - Contraindications to acetaminophen administration (liver or renal dysfunction, allergy) - Chronic pain medications - Diagnosis of chronic pain syndrome - Contraindications to morphine (renal impairment, allergy) - Seizure disorders and/or taking anti-seizure medications - Contraindications to oral midazolam (liver dysfunction, allergy) - Allergy to local anesthetics

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oral acetaminophen
Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed.
Ofirmev®
Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed.
Opioid only
Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed.

Locations

Country Name City State
United States Loma Linda University Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid (Fentanyl and Morphine) Consumption The primary outcome measure of the study will be to measure opioid (Fentanyl and Morphine) consumption during the intraoperative period first postoperative 24 hours (measured in morphine equivalents). intraoperative period and first postoperative 24 hours
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