Clinical Trial: Dexmedetomidine vs Placebo for Pediatric Cleft Palate Repair

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Randomized, Double-Blinded, Placebo Controlled Trial Using Single Dose Dexmedetomidine In The Treatment Of Pain In Patients Undergoing Cleft Palate Repair

Brief Summary: The primary objective of this study is to evaluate the efficacy of administering intravenous dexmedetomidine as a single preemptive dose to placebo in reducing the total 24 hour dose of opioids as measured on a weight adjusted morphine equivalent basis.

Detailed Summary:

The eligibility of the patient to participate in this study will be determined by the Investigator on the basis of the inclusion and exclusion criteria. Consent will be obtained from eligible patients only.

The following is the standard intraoperative anesthesia protocol utilized at Texas Children's Hospital for all children undergoing this procedure of cleft palate repair even if they are not part of the study: (1) Induction of anesthesia via a face mask with sevoflurane 6-8% and 70% N2O / 30% O2 (2) A peripheral IV will be inserted and glycopyrrolate 5-10 mcg/kg IV administered to dry oral secretions and reduce vagal responses. (3) Tracheal intubation using appropriate equipment in keeping with the clinical judgment of the anesthesia care provider. The protocol will permit the administration of propofol up to 3 mg/kg over 20-30 seconds to increase the depth of anesthesia prior to tracheal intubation if the Attending Anesthesiologist deems it necessary. (4) General anesthesia maintained with Sevoflurane/isoflurane with inhaled concentrations adjusted to keep blood pressure and heart rates within 20% of baseline. (5) Nitrous oxide will be discontinued and the lowest inspired oxygen concentration will be administered to reduce risks of airway fires while avoiding hypoxemia. (6) Fentanyl 1-2 mcg/kg administered at the start of the procedure with subsequent fentanyl 1 mcg/kg boluses as needed if the heart rate and blood pressure are increased per vital signs (HR and BP) variance greater than 20% of baseline (7) Dexamethasone 0.5 mg/kg IV. (8) Rocuronium 0.6 -1 mg/kg IV may be administered for paralysis if this is clinically indicated in the opinion of the Attending Anesthesiologist. (9) Local infiltration with 0.5% lidocaine with 1:200,000 epinephrine will be administered by the surgeon at the site of the palatoplasty in keeping with our current surgeon practice. (10) Ondans
Sponsor: Baylor College of Medicine

Current Primary Outcome:

• Postoperative pain control [ Time Frame: 24 hours ]
  Assessment of and clinical measurement that one treatment group will be better with postoperative pain management than the non-treatment group, which would be similar to published data for children undergoing this procedure. This will be measured in a mean pain score. There will be integrating of pain scores and morphine consumption.
• Opioid consumption [ Time Frame: 24 hours ]
  Opioid consumption is measured in mean morphine equivalent dose in mcg/kg, this will be integrated with the pain scores.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• The number of children with FLACC scores greater than 4 [ Time Frame: 24 hours ]
  FLACC Pain Scores
• Time to first rescue analgesia [ Time Frame: 24 hours ]
  Time in minutes to administration of first dose of rescue analgesia
• Respiratory depression [ Time Frame: 24 hours ]
  Patients with SPO2 less than 85%
• Postoperative vomiting [ Time Frame: 24 hours ]
  postoperative emesis

Original Secondary Outcome: Same as current

Information By: Baylor College of Medicine

Dates:
Date Received: September 23, 2016
Date Started: December 2016
Date Completion: December 2018
Last Updated: January 30, 2017
Last Verified: January 2017