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Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01664559
First Posted: August 14, 2012
Last Update Posted: December 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lynn Ngo, University of California, San Diego
Results First Submitted: July 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain Control With IUD Insertion
Interventions: Drug: Ketorolac
Drug: Normal Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo With 1cc Normal Saline IM

If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.

Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection

Toradol, 30mg in 1cc IM

If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.

Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume


Participant Flow:   Overall Study
    Placebo With 1cc Normal Saline IM   Toradol, 30mg in 1cc IM
STARTED   34   33 
COMPLETED   34   33 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo With 1cc Normal Saline IM

If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.

Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection

Toradol, 30mg in 1cc IM

If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.

Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume

Total Total of all reporting groups

Baseline Measures
   Placebo With 1cc Normal Saline IM   Toradol, 30mg in 1cc IM   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   33   67 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.3  (5.4)   26.6  (5.1)   26.9  (5.3) 
Gender, Customized 
[Units: Female participants]
 34   33   67 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   13   12   25 
Hispanic   4   2   6 
African American   14   12   26 
Asian or Pacific Islander   1   4   5 
Other   2   3   5 
Body mass index 
[Units: Kg/m2]
Mean (Standard Deviation)
 27.6  (5.7)   27.3  (5.8)   27.4  (5.7) 
Gravidity 
[Units: Pregnancies]
Median (Inter-Quartile Range)
 1 
 (1 to 2) 
 1 
 (1 to 2) 
 1 
 (1 to 2) 
Parity 
[Units: Pregnancies]
Median (Inter-Quartile Range)
 1 
 (1 to 1) 
 1 
 (1 to 2) 
 1 
 (1 to 1) 
Currently breastfeeding [1] 
[Units: Participants]
 15   15   30 
[1] Not all patients were breastfeeding so this number is not expected to add up to the overall number of baseline participants.
History of loop electrosurgical excision procedure 
[Units: Participants]
 0   3   3 
Level of education [1] 
[Units: Participants]
     
Less than high school   0   1   1 
High school graduate   7   4   11 
Some college   12   11   23 
College degree   7   6   13 
Graduate degree   7   11   18 
[1] One participant in the placebo arm did not answer the question about their education status, therefore the sum of the answers for this arm is different than the overall number of baseline participants.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   VAS (Visual Analogue Scale) Measurement of Pain   [ Time Frame: Pain with IUD placement, measured immediately after placement ]

2.  Secondary:   Pain Scores at Other Time Points During and After IUD Placement   [ Time Frame: immediately after each step (see description) ]

3.  Secondary:   Nulliparous Patients - Subgroup Analysis   [ Time Frame: immediately after each step (see description) ]

4.  Secondary:   Post-insertion Patient Questionnaire   [ Time Frame: assessed at 15 minutes after IUD insertion ]

5.  Secondary:   Post-insertion Provider Questionnaire   [ Time Frame: Immediately after IUD placement, on average within 1 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Lynn Ngo, Lead Study Coordinator/investigator
Organization: BWH
phone: (617)732-8798
e-mail: llngo@partners.org


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lynn Ngo, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01664559     History of Changes
Other Study ID Numbers: WRHR 5K12001259-12 - toradol
First Submitted: June 28, 2012
First Posted: August 14, 2012
Results First Submitted: July 22, 2015
Results First Posted: December 23, 2015
Last Update Posted: December 23, 2015