Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children
NCT ID: NCT02408302
Last Updated: 2015-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2015-04-30
2016-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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oral midazolam
oral midazolam 0.5-0.7 mg/kg maximum 10 mg. one dose only before the invasive procedure.
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.
intranasal midazolam
intranasal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure
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.
buccal midazolam
buccal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
5 Months
6 Years
ALL
No
Sponsors
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Carmel Medical Center
OTHER
Responsible Party
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Muriel Konopnicki
Head of Pediatric emergency room
Principal Investigators
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Muriel Konopnicki
Role: PRINCIPAL_INVESTIGATOR
Carmal Medical Center, Haifa, Israel
Locations
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Carmel Medical Center
Haifa, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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CMC-13-0075-CTIL
Identifier Type: -
Identifier Source: org_study_id
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