Clinical trial NCT02408302: Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children
Official title: Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children: A Prospective Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dormicum
Conscious Sedation
Children
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 90
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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.

Primary outcomes:
measure: time until sedation is achieved
timeFrame: 1 hour
measure: duration of sedation
timeFrame: 4 hour
measure: convenience of administration
timeFrame: 15 minutes
measure: efficacy of the sedation
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmal Medical Center, Haifa, Israel
name: Muriel Konopnicki
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.