NCT00405262

Brief Summary

The efficacy of three postoperative pain management regimens will be compared in patients undergoing Lefort I osteotomy or alveolar cleft repair with Iliac crest bone grafts (ICBG) to determine the best way of managing postoperative pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for phase_3 postoperative-pain

Timeline
Completed

Started May 2006

Typical duration for phase_3 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

August 20, 2013

Status Verified

August 1, 2013

Enrollment Period

2.4 years

First QC Date

November 28, 2006

Last Update Submit

August 19, 2013

Conditions

Postoperative Pain

Keywords

PediatricsPostoperative Analgesiaorthopedic surgeryIliac Crest Bone GraftOsteotomycleft palate

Outcome Measures

Primary Outcomes (2)

  • Pain, assessed with a numerical analog system

    As soon as the patient is able to respond appropriately and then approximately every 4 hours for 48 hours

  • Patient satisfaction score

    24 hours

Secondary Outcomes (9)

  • Morphine consumption

    Every 4 hours

  • Total number of episodes of nausea, vomiting, and pruritis

    48 hours

  • Doses of all anti-emetics

    48 hours

  • Heart rate and respiratory rate variables

    48 hours

  • Time to first ambulation

    Time determined by outcome

  • +4 more secondary outcomes

Study Arms (3)

1

ACTIVE COMPARATOR
Drug: Ketorolac

2

EXPERIMENTAL
Drug: Bupivacaine

3

EXPERIMENTAL
Drug: ketorolac + bupivacaine

Interventions

KetorolacDRUG

0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter

1
BupivacaineDRUG

0.2 mL•kg-1 (lean body mass) bolus of bupivacaine 0.25% with epinephrine 1:200 000 will be injected through the IC catheter at the end surgery before the patient's trachea is extubated to detect intravascular injection. An infusion of the same solution will be started at 0.1 mL•kg-1•hour-1 (lean body mass) for 24 hours.

2
ketorolac + bupivacaineDRUG

0.2 mL•kg-1 (lean body mass) bolus of bupivacaine 0.25% with epinephrine 1:200 000 will be injected through the IC catheter at the end surgery before the patient's trachea is extubated to detect intravascular injection. An infusion of the same solution will be started at 0.1 mL•kg-1•hour-1 (lean body mass) for 24 hours. For ketorolac, patients will receive 0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter

3

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Alveolar bone graft patients age 10-13 years of age
  • Lefort I osteotomy patients needing ICBG age 14 to 20 years
  • able to operate a patient-controlled analgesia (PCA) device

You may not qualify if:

  • Allergy, sensitivity or contraindication to any non-steroidal anti-inflammatory drugs
  • Allergy, sensitivity or contraindication to morphine
  • History of gastric ulcer or bleeding diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • Hayes JA, Forrest CR, Walsh W, Petroz GC, Adeli K, Bissonnette B. Continuous bupivacaine infusion post-iliac crest bone graft harvesting in pediatric cleft surgery: role and comparison with ketorolac. Cleft Palate Craniofac J. 2011 Sep;48(5):532-7. doi: 10.1597/10-148. Epub 2010 Nov 23.

    PMID: 21091369DERIVED

MeSH Terms

Conditions

Pain, PostoperativeCleft Palate

Interventions

KetorolacBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsJaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMouth AbnormalitiesMouth DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jason Hayes, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 30, 2006

Study Start

May 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

August 20, 2013

Record last verified: 2013-08

Locations

CA(1)