Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children

Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children: A Prospective Randomized Control Study

Currently Midazolam sedation is the standard of care for minor invasive procedures in pediatric patients; its use is restricted to two routes of administration for this purpose oral and intranasal.

A third route of administration (buccal) is tested and approved for seizure management. In the investigators' study the researchers investigate the buccal route of administration versus oral or intranasal administration for sedation. The investigators' hypothesis is that buccal route of administration is more convenient than intranasal and better absorbed than oral.

Study Overview

• Status: Unknown
• Conditions: Children; Conscious Sedation; Dormicum
• Intervention / Treatment: Drug: Midazolam

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Muriel Konopnicki; Phone Number: 972-4-8250240; Email: MurielKo2@clalit.org.il

Study Locations

• Israel
  • Haifa, Israel
    • Carmel Medical Center
    • Contact: Muriel Konopnicki, MD; Phone Number: 972-4-8250240; Email: MurielKo2@clalit.org.il
    • Principal Investigator: Muriel Konopnicki, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 5 months to 6 years.
• need to undergo a minimal invasive procedure that requires light sedation.
• ASA (American Society of Anesthesiologists) I-II
• parent that can read, understand and sign an informed consent form

Exclusion Criteria:

• patients with life threatening conditions.
• patients with respiratory or cardiac chronic illnesses or ASA other than I-II.
• patients with traumatic injury for the nose or the oral cavity.
• patients that would not or cannot take the drug in the route picked in a randomized way.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: oral midazolam; oral midazolam 0.5-0.7 mg/kg maximum 10 mg. one dose only before the invasive procedure.	Drug: Midazolam; comparison between 3 routes of administration of the drug Midazolam used for sedation for minor procedures in pediatric population. the routes are oral intranasal and buccal.; Other Names: Dormicum
Active Comparator: intranasal midazolam; intranasal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure	Drug: Midazolam; comparison between 3 routes of administration of the drug Midazolam used for sedation for minor procedures in pediatric population. the routes are oral intranasal and buccal.; Other Names: Dormicum
Active Comparator: buccal midazolam; buccal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure	Drug: Midazolam; comparison between 3 routes of administration of the drug Midazolam used for sedation for minor procedures in pediatric population. the routes are oral intranasal and buccal.; Other Names: Dormicum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time until sedation is achieved		1 hour
duration of sedation	time from achieving sedation until reaching full consciousness	4 hour
convenience of administration	described by the parent and the physician by a numerical rating scale (NRS) questionaire	15 minutes
efficacy of the sedation	described by the parent, nurse and physician by a NRS questionaire	4 hours

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Investigators: Principal Investigator: Muriel Konopnicki, Carmal Medical Center, Haifa, Israel

Publications and helpful links

General Publications

• American Academy of Pediatrics; American Academy of Pediatric Dentistry, Cote CJ, Wilson S; Work Group on Sedation. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: an update. Pediatrics. 2006 Dec;118(6):2587-602. doi: 10.1542/peds.2006-2780.
• Godwin SA, Caro DA, Wolf SJ, Jagoda AS, Charles R, Marett BE, Moore J; American College of Emergency Physicians. Clinical policy: procedural sedation and analgesia in the emergency department. Ann Emerg Med. 2005 Feb;45(2):177-96. doi: 10.1016/j.annemergmed.2004.11.002. No abstract available.
• Krauss B, Green SM. Sedation and analgesia for procedures in children. N Engl J Med. 2000 Mar 30;342(13):938-45. doi: 10.1056/NEJM200003303421306. No abstract available.
• Krauss B, Green SM. Procedural sedation and analgesia in children. Lancet. 2006 Mar 4;367(9512):766-80. doi: 10.1016/S0140-6736(06)68230-5.
• Procacci P, Francini F, Zoppi M, Maresca M. Cutaneous pain threshold changes after sympathetic block in reflex dystrophies. Pain. 1975 Jun;1(2):167-175. doi: 10.1016/0304-3959(75)90100-1.
• American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology. 2002 Apr;96(4):1004-17. doi: 10.1097/00000542-200204000-00031. No abstract available.
• Shavit I, Feraru L, Miron D, Weiser G. Midazolam for urethral catheterisation in female infants with suspected urinary tract infection: a case-control study. Emerg Med J. 2014 Apr;31(4):278-80. doi: 10.1136/emermed-2012-202088. Epub 2013 Feb 22.
• McErlean M, Bartfield JM, Karunakar TA, Whitman MC, Turley DM. Midazolam syrup as a premedication to reduce the discomfort associated with pediatric intravenous catheter insertion. J Pediatr. 2003 Apr;142(4):429-30. doi: 10.1067/mpd.2003.62.
• Lane RD, Schunk JE. Atomized intranasal midazolam use for minor procedures in the pediatric emergency department. Pediatr Emerg Care. 2008 May;24(5):300-3. doi: 10.1097/PEC.0b013e31816ecb6f.
• Wiznitzer M. Buccal midazolam is effective for acute treatment of seizures. J Pediatr. 2006 Jan;148(1):143. doi: 10.1016/j.jpeds.2005.12.008. No abstract available.
• Wiznitzer M. Buccal midazolam for seizures. Lancet. 2005 Jul 16-22;366(9481):182-3. doi: 10.1016/S0140-6736(05)66884-5. No abstract available.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Estimate): April 9, 2015
• Last Update Submitted That Met QC Criteria: April 8, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: CMC-13-0075-CTIL