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

NCT02408302 | Unknown Phase 4

• 1 other identifier: CMC-13-0075-CTIL
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dormicum; Conscious Sedation; Children

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

oral midazolam

ACTIVE COMPARATOR

oral midazolam 0.5-0.7 mg/kg maximum 10 mg. one dose only before the invasive procedure.

Drug: Midazolam

intranasal midazolam

ACTIVE COMPARATOR

intranasal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure

Drug: Midazolam

buccal midazolam

ACTIVE COMPARATOR

buccal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure

Drug: Midazolam

Interventions

Midazolam DRUG

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.

Also known as: Dormicum

buccal midazolam; intranasal midazolam; oral midazolam

Eligibility Criteria

• Age: 5 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical Center

Haifa, Israel

Location

Related Publications (11)

• 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.

  PMID: 10738053 BACKGROUND

• 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.

  PMID: 16517277 BACKGROUND

• 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.

  PMID: 17142550 BACKGROUND

• 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.

  PMID: 1235980 BACKGROUND

• 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.

  PMID: 11964611 BACKGROUND

• 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.

  PMID: 15671976 BACKGROUND

• 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.

  PMID: 23435653 BACKGROUND

• 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.

  PMID: 12712062 BACKGROUND

• 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.

  PMID: 18496113 BACKGROUND

• 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.

  PMID: 16440479 BACKGROUND

• 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.

  PMID: 16023491 BACKGROUND

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Muriel Konopnicki

  Carmal Medical Center, Haifa, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muriel Konopnicki

CONTACT

972-4-8250240; MurielKo2@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric emergency room

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 3, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 9, 2015

Record last verified: 2015-03

Locations

IL (1)