NCT01165814

Brief Summary

Oral naproxen might be more efficacious for post-cesarean pain-control and have better side-effects profile than oral tramadol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable 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

August 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2010

Completed
Last Updated

July 20, 2010

Status Verified

July 1, 2010

Enrollment Period

2.6 years

First QC Date

July 18, 2010

Last Update Submit

July 19, 2010

Conditions

PainCesarean Section

Keywords

Pain control after cesarean section

Outcome Measures

Primary Outcomes (1)

  • Pain Score

Secondary Outcomes (1)

  • Side effects

Study Arms (4)

Tramadol at fixed intervals

ACTIVE COMPARATOR
Drug: Naproxen Tramadol

Tramadol on request

ACTIVE COMPARATOR
Drug: Naproxen Tramadol

Naproxen at fixed intervals

ACTIVE COMPARATOR
Drug: Naproxen Tramadol

Naproxen on request

ACTIVE COMPARATOR
Drug: Naproxen Tramadol

Interventions

Naproxen TramadolDRUG
Naproxen at fixed intervalsNaproxen on requestTramadol at fixed intervalsTramadol on request

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patients after cesarean section

You may not qualify if:

  • emergent CS
  • hypersensitivity to drug
  • drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 18, 2010

First Posted

July 20, 2010

Study Start

August 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 20, 2010

Record last verified: 2010-07

Locations

IL(1)