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

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02408302
• Other study ID #: CMC-13-0075-CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 31, 2015
• Last updated: April 8, 2015
• Start date: April 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2015
• Source: Carmel Medical Center
• Contact: Muriel Konopnicki
• Phone: 972-4-8250240
• Email: MurielKo2[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Months to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Children
• Conscious Sedation
• Dormicum

Intervention

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.

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (11)

American Academy of Pediatrics; American Academy of Pediatric Dentistry, Coté 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. — View 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. — View 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. Review. — View Citation

Krauss B, Green SM. Procedural sedation and analgesia in children. Lancet. 2006 Mar 4;367(9512):766-80. Review. — View Citation

Krauss B, Green SM. Sedation and analgesia for procedures in children. N Engl J Med. 2000 Mar 30;342(13):938-45. Review. — View 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. — View 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. — View Citation

Procacci P, Francini F, Zoppi M, Maresca M. Cutaneous pain threshold changes after sympathetic block in reflex dystrophies. Pain. 1975 Jun;1(2):167-75. — View 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. — View Citation

Wiznitzer M. Buccal midazolam for seizures. Lancet. 2005 Jul 16-22;366(9481):182-3. — View Citation

Wiznitzer M. Buccal midazolam is effective for acute treatment of seizures. J Pediatr. 2006 Jan;148(1):143. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time until sedation is achieved		1 hour	No
Primary	duration of sedation	time from achieving sedation until reaching full consciousness	4 hour	No
Primary	convenience of administration	described by the parent and the physician by a numerical rating scale (NRS) questionaire	15 minutes	No
Primary	efficacy of the sedation	described by the parent, nurse and physician by a NRS questionaire	4 hours	No