Dexmedetomidine vs Placebo for Pediatric Cleft Palate Repair

NCT02915042 | Withdrawn Phase 4

• 1 other identifier: H-34431
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cleft Palate

Keywords

Pain; dexmedetomidine; postoperative

Outcome Measures

Primary Outcomes (2)

• Postoperative pain control

  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.

  24 hours

• Opioid consumption

  Opioid consumption is measured in mean morphine equivalent dose in mcg/kg, this will be integrated with the pain scores.

  24 hours

Secondary Outcomes (4)

• The number of children with FLACC scores greater than 4

  24 hours

• Time to first rescue analgesia

  24 hours

• Respiratory depression

  24 hours

• Postoperative vomiting

  24 hours

Study Arms (2)

Experimental group

EXPERIMENTAL

Intervention group 1: pre-operative administration of IV dexmedetomidine 1mcg/kg

Drug: Dexmedetomidine

Placebo group

PLACEBO COMPARATOR

Intervention group 2: placebo

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Analgesic Efficacy

Also known as: Precedex

Experimental group

Placebo DRUG

Saline placebo

Also known as: Saline

Placebo group

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients between 6mo to 8 years of age scheduled to undergo primary or secondary cleft repair.

You may not qualify if:

• Patients with significant cognitive impairment
• Patients with various syndromes known to be associated with difficult airways(e.g. Goldenhar's syndrome, Treacher- Collins, Trisomy 13 or 18, Pierre Robin, etc.)
• Have a prior history of allergy, hypersensitivity or contraindication to any drug used for anesthesia including opioids (morphine, fentanyl, hydrocodone) and inhalation agents(i.e. children with susceptibility to malignant hyperthermia)
• Have a history of congenital bleeding diathesis(e.g. hemophilia) or any active clinically significant bleeding, impaired renal or hepatic function
• Children with heart failure, heart block, ventricular dysfunction, cardiomyopathy, myocarditis or congenital heart disease where cardiac output is rate dependent and relies on A-V synchrony (e.g. single ventricle). Children with well controlled atrial or ventricular septal defects, patent ductus arteriosus, repaired coarctation of the aorta will qualify if they have no cardiac rhythm or hypertension problems.
• Children with uncontrolled hypertension, intracranial vascular malformations, Moya Moya disease or intracranial hypertension.
• Any child who has received an investigational drugs within 30 days before study drug administration.
• Inability of the parent or legal guardian to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board) and agree to abide by the study restrictions.
• Be otherwise unsuitable for the study, in the opinion of the Investigator.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Related Publications (20)

• Kelly LE, Rieder M, van den Anker J, Malkin B, Ross C, Neely MN, Carleton B, Hayden MR, Madadi P, Koren G. More codeine fatalities after tonsillectomy in North American children. Pediatrics. 2012 May;129(5):e1343-7. doi: 10.1542/peds.2011-2538. Epub 2012 Apr 9.

  PMID: 22492761 BACKGROUND

• Mason KP, Lerman J. Review article: Dexmedetomidine in children: current knowledge and future applications. Anesth Analg. 2011 Nov;113(5):1129-42. doi: 10.1213/ANE.0b013e31822b8629. Epub 2011 Aug 4.

  PMID: 21821507 BACKGROUND

• Pickard A, Davies P, Birnie K, Beringer R. Systematic review and meta-analysis of the effect of intraoperative alpha(2)-adrenergic agonists on postoperative behaviour in children. Br J Anaesth. 2014 Jun;112(6):982-90. doi: 10.1093/bja/aeu093. Epub 2014 Apr 11.

  PMID: 24727829 BACKGROUND

• Sun Y, Lu Y, Huang Y, Jiang H. Is dexmedetomidine superior to midazolam as a premedication in children? A meta-analysis of randomized controlled trials. Paediatr Anaesth. 2014 Aug;24(8):863-74. doi: 10.1111/pan.12391. Epub 2014 Mar 26.

  PMID: 24666837 BACKGROUND

• Schnabel A, Reichl SU, Poepping DM, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of intraoperative dexmedetomidine for acute postoperative pain in children: a meta-analysis of randomized controlled trials. Paediatr Anaesth. 2013 Feb;23(2):170-9. doi: 10.1111/pan.12030. Epub 2012 Oct 9.

  PMID: 23043461 BACKGROUND

• Olutoye OA, Glover CD, Diefenderfer JW, McGilberry M, Wyatt MM, Larrier DR, Friedman EM, Watcha MF. The effect of intraoperative dexmedetomidine on postoperative analgesia and sedation in pediatric patients undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Aug;111(2):490-5. doi: 10.1213/ANE.0b013e3181e33429. Epub 2010 Jul 7.

  PMID: 20610555 BACKGROUND

• Petroz GC, Sikich N, James M, van Dyk H, Shafer SL, Schily M, Lerman J. A phase I, two-center study of the pharmacokinetics and pharmacodynamics of dexmedetomidine in children. Anesthesiology. 2006 Dec;105(6):1098-110. doi: 10.1097/00000542-200612000-00009.

  PMID: 17122572 BACKGROUND

• Potts AL, Anderson BJ, Warman GR, Lerman J, Diaz SM, Vilo S. Dexmedetomidine pharmacokinetics in pediatric intensive care--a pooled analysis. Paediatr Anaesth. 2009 Nov;19(11):1119-29. doi: 10.1111/j.1460-9592.2009.03133.x. Epub 2009 Aug 25.

  PMID: 19708909 BACKGROUND

• Mason KP, Robinson F, Fontaine P, Prescilla R. Dexmedetomidine offers an option for safe and effective sedation for nuclear medicine imaging in children. Radiology. 2013 Jun;267(3):911-7. doi: 10.1148/radiol.13121232. Epub 2013 Feb 28.

  PMID: 23449958 BACKGROUND

• Tobias JD, Gupta P, Naguib A, Yates AR. Dexmedetomidine: applications for the pediatric patient with congenital heart disease. Pediatr Cardiol. 2011 Dec;32(8):1075-87. doi: 10.1007/s00246-011-0092-8. Epub 2011 Sep 10.

  PMID: 21909772 BACKGROUND

• Chen ZF, Chen YK, Guo Y, Jiang H. [Effect of dexmedetomidine on emergence agitation after oral and maxillofacial surgery]. Shanghai Kou Qiang Yi Xue. 2013 Dec;22(6):698-701. Chinese.

  PMID: 24469137 BACKGROUND

• Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.

  PMID: 20705788 BACKGROUND

• Nour C, Ratsiu J, Singh N, Mason L, Ray A, Martin M, Hassanian M, Uhler J, Applegate RL 2nd. Analgesic effectiveness of acetaminophen for primary cleft palate repair in young children: a randomized placebo controlled trial. Paediatr Anaesth. 2014 Jun;24(6):574-81. doi: 10.1111/pan.12393. Epub 2014 Apr 2.

  PMID: 24697925 BACKGROUND

• Kayyal TA, Wolfswinkel EM, Weathers WM, Capehart SJ, Monson LA, Buchanan EP, Glover CD. Treatment effects of dexmedetomidine and ketamine on postoperative analgesia after cleft palate repair. Craniomaxillofac Trauma Reconstr. 2014 Jun;7(2):131-8. doi: 10.1055/s-0034-1371446. Epub 2014 Feb 28.

  PMID: 25045418 BACKGROUND

• Berde CB, Sethna NF. Analgesics for the treatment of pain in children. N Engl J Med. 2002 Oct 3;347(14):1094-103. doi: 10.1056/NEJMra012626. No abstract available.

  PMID: 12362012 BACKGROUND

• Lonnqvist PA, Morton NS. Postoperative analgesia in infants and children. Br J Anaesth. 2005 Jul;95(1):59-68. doi: 10.1093/bja/aei065. Epub 2005 Jan 21. No abstract available.

  PMID: 15668207 BACKGROUND

• Mason KP, Zurakowski D, Zgleszewski S, Prescilla R, Fontaine PJ, Dinardo JA. Incidence and predictors of hypertension during high-dose dexmedetomidine sedation for pediatric MRI. Paediatr Anaesth. 2010 Jun;20(6):516-23. doi: 10.1111/j.1460-9592.2010.03299.x. Epub 2010 Apr 14.

  PMID: 20412458 BACKGROUND

• Mascha EJ, Turan A. Joint hypothesis testing and gatekeeping procedures for studies with multiple endpoints. Anesth Analg. 2012 Jun;114(6):1304-17. doi: 10.1213/ANE.0b013e3182504435. Epub 2012 May 3.

  PMID: 22556210 BACKGROUND

• Dai F, Silverman DG, Chelly JE, Li J, Belfer I, Qin L. Integration of pain score and morphine consumption in analgesic clinical studies. J Pain. 2013 Aug;14(8):767-77.e8. doi: 10.1016/j.jpain.2013.04.004. Epub 2013 Jun 3.

  PMID: 23743256 BACKGROUND

• Farag E, Atim A, Ghosh R, Bauer M, Sreenivasalu T, Kot M, Kurz A, Dalton JE, Mascha EJ, Mounir-Soliman L, Zaky S, Ali Sakr Esa W, Udeh BL, Barsoum W, Sessler DI. Comparison of three techniques for ultrasound-guided femoral nerve catheter insertion: a randomized, blinded trial. Anesthesiology. 2014 Aug;121(2):239-48. doi: 10.1097/ALN.0000000000000262.

  PMID: 24758775 BACKGROUND

Related Links

• Medical staff resource

MeSH Terms

Conditions

Cleft Palate; Pain

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Chris D. Glover, MD

  Baylor College of Medicine - Texas Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Chris Darrel Glover Assistant Professor Anesthesiology Texas Children's Hospital Baylor College of Medicine

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 26, 2016
• Study Start: December 31, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share