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Oral Ketorolac for Pain Relief During IUD Insertion

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.
ClinicalTrials.gov Identifier: NCT03031795
Recruitment Status : Completed
First Posted : January 26, 2017
Results First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
OhioHealth

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Contraception
Interventions Drug: Ketorolac
Drug: Placebo
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental Placebo
Hide Arm/Group Description

ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement

Ketorolac: Oral Tablet

look alike placebo

Placebos

Period Title: Overall Study
Started 35 36
Completed 35 35
Not Completed 0 1
Arm/Group Title Ketorolac Placebo Total
Hide Arm/Group Description Experimental group Control group Total of all reporting groups
Overall Number of Baseline Participants 35 36 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 71 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
 100.0%
36
 100.0%
71
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 36 participants 71 participants
31.9  (6.7) 30.7  (8.9) 31.3  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 71 participants
Female
35
 100.0%
36
 100.0%
71
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/ethnicity Number Analyzed 35 participants 36 participants 71 participants
White
27
  77.1%
22
  61.1%
49
  69.0%
Black
5
  14.3%
10
  27.8%
15
  21.1%
Hispanic
0
   0.0%
1
   2.8%
1
   1.4%
Asian
1
   2.9%
1
   2.8%
2
   2.8%
Other
2
   5.7%
2
   5.6%
4
   5.6%
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 35 participants 36 participants 71 participants
35
 100.0%
36
 100.0%
71
 100.0%
1.Primary Outcome
Title Pain Before, During and After IUD Placement
Hide Description Pain before, during and after IUD placement on a 0 (no pain) to 10 (worst possible) scale. Higher score mean a worse outcome.
Time Frame Before, during and after IUD placement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Placebo
Hide Arm/Group Description:
Experimental group
Placebo group
Overall Number of Participants Analyzed 35 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pain expected during the procedure 4.1  (2.2) 4.5  (2.4)
Pre-procedure pain rating 0.4  (1.0) 0.7  (1.5)
Tenaculum placement 2.7  (2.2) 3.2  (2.4)
Uterine sounding 3.3  (2.9) 4.2  (2.9)
Deployment of the IUD 4.2  (2.9) 5.7  (2.9)
Overall pain rating during the procedure 3.6  (2.9) 4.9  (2.7)
Level of pain 10 minutes post procedure 1.1  (1.5) 2.5  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketorolac, Placebo
Comments A 2 point difference was used to power the study. This is consistent with previous definitions of a clinically meaningful reductions in pain and provides a visually meaningful change on the 0-10 numerical rating scale with anchors at every other point, for example moving from “very severe” (8) to “severe pain” (6) or from “moderate pain” (4) to “mild pain” (2).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments The a priori threshold for statistical significance was set at < 0.05 for each row comparison with no adjustment for multiple comparisons.
Method Wilcoxon rank sum test
Comments [Not Specified]
Time Frame 45 minutes prior and up to 10 minutes post IUD placement
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Placebo
Hide Arm/Group Description

ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement

Ketorolac: Oral Tablet

look alike placebo

Placebos

All-Cause Mortality
Experimental Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/36 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/36 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: John O. Elliott PhD, MPH Research Specialist Medical Education
Organization: OhioHealth
Phone: 614-566-3643
Responsible Party: OhioHealth
ClinicalTrials.gov Identifier: NCT03031795     History of Changes
Other Study ID Numbers: OH1-13-00503
First Submitted: November 30, 2016
First Posted: January 26, 2017
Results First Submitted: September 13, 2017
Results First Posted: September 26, 2018
Last Update Posted: September 26, 2018