Not Yet RecruitingPhase 3ACTRN12616001078448

A trial to compare the quality of induction using two different premedication combinations in children with Autism Spectrum Disorder (ASD) undergoing surgery.

Premedication and preparation for children with Autism Spectrum Disorder: A multi-centre randomised, blinded trial to determine the quality of induction using combination of low dose clonidine and midazolam versus placebo plus high dose of midazolam as premedication.


Sponsor

Murdoch Children Research Institute (MCRI)

Enrollment

114 participants

Start Date

Sep 3, 2016

Study Type

Interventional

Conditions

Summary

this trial aims to improve the experiences of children with ASD having an operation in Royal Dental hospital and the Royal Children's Hospital . The participants will be selected from operating list and a preparation package will be sent after verbal consent. on the day of operation if the child requires premedication, they are randomised to clonidine plus midazolam at lower doses vs. placebo plus standard dose of midazolam. the primary end point is the quality of induction as measured by Almanrader scale.


Eligibility

Sex: Both males and femalesMin Age: 4 YearssMax Age: 16 Yearss

Inclusion Criteria1

  • Diagnosed with ASD , between the ages of 4-16 years, ASA 1 or 2, No contraindication to premedication. Any type of operation is permitted. They are scheduled to undergo surgery.

Exclusion Criteria1

  • ASA 3 or 4, cardiac/ respiratory conditions that exclude the use of sedation, obesity with weight more than 95% for age or BMI >30 (whatever is lower), previous intolerance or allergy to either medication or formulation component, Gastrointestinal disorders that affect absorption.

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Interventions

Children with ASD who require premedication for operation and have received the preparation package, will be randomised to either placebo (water) plus standard dose of midazolam or low doses of cloni

Children with ASD who require premedication for operation and have received the preparation package, will be randomised to either placebo (water) plus standard dose of midazolam or low doses of clonidine plus midazolam. The intervention group will be given clonidine 3mcg/kg, 60 minutes before the operation and midazolam 0.3 mg/kg, 30 minutes before the operation. The maximum dose of clonidine is 250 mcg and maximal dose of midazolam is 12 mg. The standard of care group will receive water (placebo) 60 minutes before the operation and 0.5 mg of midazolam 30 minutes before the operation. the maximum dose of midazolam is 20 mg. All medication will be given orally. The preparation package includes a face mask to practice, information re trial and how to prepare and distract the child, baseline information about the child and 3 booklets to choose from in order to prepare children for operation. these booklets are social stories that are for children with different level of understanding and the standard hospital booklet. The social stories are prepared by chief investigator (Dr Taghizadeh). The hospital booklet is written by Marieke Mitchell and is called "Going to hospital, what will it be like?". Social story are very commonly used in the educational setting and multiple studies support their use. The concept of social story was developed by Carol Gray (Gray and Garand, 1993) in order to explain social situations to children with ASD and to teach them the appropriate responses that are expected of them. Gary suggested a specific combination of directive, perspective and descriptive sentences. Parents may choose any booklet that they find helpful to their child. The preparation package is sent 7-10 days before the operation.


Locations(2)

The Royal Dental Hospital of Melbourne - Carlton

VIC, Australia

The Royal Childrens Hospital - Parkville

VIC, Australia

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ACTRN12616001078448