Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair

Loma Linda University (LLU)

Status: Completed

Conditions: Cleft Palate

Treatments: Drug: Opioid only; Drug: Ofirmev®; Drug: Oral acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT01500109

5110257

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 5 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups, including a placebo group

Ofirmev®

Experimental group

Description:

Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev® will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.

Treatment:

Drug: Ofirmev®

Oral acetaminophen

Active Comparator group

Description:

Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev® (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.

Treatment:

Drug: Oral acetaminophen

Opioid only

Placebo Comparator group

Description:

This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.

Treatment:

Drug: Opioid only