NCT01636700

Brief Summary

The purpose of this study is to evaluate the analgesic effect and IL-6 after tramadol infiltration or intravenous for tonsillectomy.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

July 28, 2015

Status Verified

February 1, 2014

Enrollment Period

2.8 years

First QC Date

July 5, 2012

Last Update Submit

July 27, 2015

Conditions

Postoperative Pain

Keywords

Tramadol infiltrationAnalgesic effectSerum IL-6

Outcome Measures

Primary Outcomes (1)

  • Analgesic effect

    24 hours

Study Arms (2)

tramadol infiltration

ACTIVE COMPARATOR

infiltration of tramadol 2mg/kg

Drug: Tramadol 2mg/kg

Saline solution

PLACEBO COMPARATOR

Infiltration of saline

Drug: Saline solution

Interventions

Tramadol 2mg/kgDRUG

2mg/kg

Also known as: Opioid
tramadol infiltration
Saline solutionDRUG

saline solution- 1 dose

Also known as: Placebo
Saline solution

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy

You may not qualify if:

  • coagulopathy,
  • cancer,
  • hepatic or renal alteration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, São Paulo, 04044020, Brazil

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

TramadolAnalgesics, OpioidSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsNarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Rioko K Sakata

    Universidade Federal de São Paulo

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pain Clinic Director

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 10, 2012

Study Start

October 1, 2011

Primary Completion

July 1, 2014

Study Completion

October 1, 2014

Last Updated

July 28, 2015

Record last verified: 2014-02

Locations

BR(1)