NCT00662987

Brief Summary

To determine whether a 3-day course of postoperative antibiotics is effective as a 7-day course in reducing pain and reducing time to resumption of normal diet and activity following pediatric tonsillectomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
Last Updated

April 21, 2008

Status Verified

April 1, 2008

Enrollment Period

1.7 years

First QC Date

April 17, 2008

Last Update Submit

April 17, 2008

Conditions

Tonsillectomy

Keywords

tonsillectomyantibiotics

Outcome Measures

Primary Outcomes (1)

  • analgesic use

    1 week

Secondary Outcomes (2)

  • time of resumption of normal diet

    1 week

  • time of resumption of normal activity

    1 week

Study Arms (2)

Group B

PLACEBO COMPARATOR

Received 3 days of amoxicillin followed by 4 days of placebo

Drug: 3 days of amoxcillin followed by 4 days of placebo

Group A

ACTIVE COMPARATOR

Received 7 days of amoxicillin

Drug: 7 days of amoxicillin

Interventions

7 days of amoxicillinDRUG

Received 7 days of amoxicillin (dosed 40mg/kg divided bid up to maximum daily dose of 800 mg)

Group A
3 days of amoxcillin followed by 4 days of placeboDRUG

3 days of amoxicillin (40 mg/kg divided bid up to maximum daily dose of 800 mg) followed by placebo

Group B

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • tonsillectomy with or without adenoidectomy
  • under the age of 18

You may not qualify if:

  • penicillin allergy
  • took antibiotics within 7 days of surgery
  • medical comorbidity requiring treatment with antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Related Publications (1)

  • Johnson PE, Rickert SM, Jones J. Duration-related efficacy of postoperative antibiotics following pediatric tonsillectomy: a prospective, randomized, placebo-controlled trial. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):984-7. doi: 10.1001/archoto.2009.146.

    PMID: 19841335DERIVED

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jacqueline Jones, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 21, 2008

Study Start

September 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

April 21, 2008

Record last verified: 2008-04

Locations

US(1)