A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants

PHASE4CompletedINTERVENTIONAL
Enrollment

643

Participants

Timeline

Start Date

October 23, 2006

Primary Completion Date

June 30, 2018

Study Completion Date

June 30, 2018

Conditions
Inguinal Hernia
Interventions
DRUG

Regional Anesthesia

Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.

DRUG

General Anesthesia

Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.

Trial Locations (30)

3052

Royal Children's Hospital, Parkville

3144

Cabrini Hospital, Malvern

3165

Monash Medical Centre, Clayton

3806

Casey Hospital, Berwick

5006

Adelaide Women's and Children's Hospital, North Adelaide

6008

Princess Margaret Hospital, Perth

16147

G. Gaslini Children's Hospital, Genoa

19104

Children's Hospital of Philadelphia, Philadelphia

20100

'Vitore Buzzi' Children's Hospital, Milan

24100

Ospedali Riuniti Di Bergamo, Bergamo

37212

Vanderbilt Children's Hospital, Nashville

52242

The University of Iowa Hospital, Iowa City

60614

Children's Memorial Hospital, Chicago

75235

Children's Medical Center of Dallas, Dallas

80045

The Children's Hospital Denver, Aurora

98105

Seattle Children's Hospital, Seattle

02115

Children's Hospital Boston, Boston

03756

Dartmouth-Hitchcock Medical Center, Lebanon

05401

Vermont Children's Hospital at Fletcher Allen Health Care, Burlington

H3H 1P3

Montreal Children's Hospital, Montreal

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

9700 RB

Universitair Medisch Centrum Groningen, Groningen

Unknown

Wilhelmina Children's Hospital; University Medical Centre Utrecht, Utrecht

Starship Children's Health, Auckland

BT12 6BE

Royal Belfast Hospital for Sick Children, Belfast

B4 6NH

Birmingham Children's Hospital, Birmingham

BS2 8BJ

Bristol Royal Hospital for Children, Bristol

G3 8SJ

Royal Hospital for Sick Children, Glasgow

L12 2APS

Royal Liverpool Children's Hospital, Liverpool

S10 2TS

Sheffield Children's Hospital, Sheffield

Sponsors
All Listed Sponsors
collaborator

Royal Children's Hospital

OTHER

collaborator

Royal Hospital for Sick Children

OTHER

collaborator

Murdoch Childrens Research Institute

OTHER

collaborator

Food and Drug Administration (FDA)

FED

lead

Boston Children's Hospital

OTHER