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Trial record 46 of 476 for:    KETOROLAC

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

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: NCT01664559
Recruitment Status : Completed
First Posted : August 14, 2012
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Lynn Ngo, University of California, San Diego

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
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo With 1cc Normal Saline IM Toradol, 30mg in 1cc IM
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 34 33
Completed 34 33
Not Completed 0 0
Arm/Group Title Placebo With 1cc Normal Saline IM Toradol, 30mg in 1cc IM Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 34 33 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 33 participants 67 participants
27.3  (5.4) 26.6  (5.1) 26.9  (5.3)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Female participants
Number Analyzed 34 participants 33 participants 67 participants
34 33 67
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 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  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 34 participants 33 participants 67 participants
27.6  (5.7) 27.3  (5.8) 27.4  (5.7)
Gravidity  
Median (Inter-Quartile Range)
Unit of measure:  Pregnancies
Number Analyzed 34 participants 33 participants 67 participants
1
(1 to 2)
1
(1 to 2)
1
(1 to 2)
Parity  
Median (Inter-Quartile Range)
Unit of measure:  Pregnancies
Number Analyzed 34 participants 33 participants 67 participants
1
(1 to 1)
1
(1 to 2)
1
(1 to 1)
Currently breastfeeding   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
15 15 30
[1]
Measure Description: 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 participants
0 3 3
Level of education   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 33 participants 67 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]
Measure Description: 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.
1.Primary Outcome
Title VAS (Visual Analogue Scale) Measurement of Pain
Hide Description The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.
Time Frame Pain with IUD placement, measured immediately after placement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo With 1cc Normal Saline IM Toradol, 30mg in 1cc IM
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 34 33
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
5.2
(1.2 to 7.4)
3.6
(1.5 to 6.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Pain Scores at Other Time Points During and After IUD Placement
Hide Description

The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.

  1. Prior to injection of study drug, anticipated pain
  2. Pain from study drug injection, measured immediately after injection
  3. Pain from speculum insertion, measured immediately after insertion
  4. Pain with tenaculum placement, measured immediately after placement
  5. Pain with uterine sounding, measured immediately after removal of the sound
  6. Pain at 5 minutes after placement of the intrauterine device
  7. Pain at 15 minutes after placement of the intrauterine device
Time Frame immediately after each step (see description)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo With 1cc Normal Saline IM Toradol, 30mg in 1cc IM
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 34 33
Median (Inter-Quartile Range)
Unit of Measure: cm
Anticipated pain
4.4
(1.4 to 6.5)
3.5
(1.0 to 6.8)
Pain with injection
1.0
(0.4 to 2.8)
0.6
(0.2 to 1.3)
Speculum insertion
2.6
(0.6 to 3.7)
1.5
(0.4 to 3.8)
Tenaculum placement
3.9
(2.6 to 5.7)
2.5
(1.1 to 6.4)
Uterine sounding
5.0
(2.5 to 7.5)
4.3
(1.7 to 7.2)
5 min after procedure
2.2
(0.8 to 3.9)
0.3
(0 to 1.3)
15 min after procedure
1.6
(0.4 to 3.6)
0.1
(0 to 0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 1) Anticipated pain
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 2) pain with injection
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 3) speculum insertion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 4) tenaculum placement
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 5) uterine sounding
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 6) 5 min after placement
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 7) 15 min after placement
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Nulliparous Patients - Subgroup Analysis
Hide Description

The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.

  1. Prior to injection of study drug, anticipated pain
  2. Pain from study drug injection, measured immediately after injection
  3. Pain from speculum insertion, measured immediately after insertion
  4. Pain with tenaculum placement, measured immediately after placement
  5. Pain with uterine sounding, measured immediately after removal of the sound
  6. Pain at 5 minutes after placement of the intrauterine device
  7. Pain at 15 minutes after placement of the intrauterine device
Time Frame immediately after each step (see description)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo With 1cc Normal Saline IM Toradol, 30mg in 1cc IM
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 8 8
Median (Inter-Quartile Range)
Unit of Measure: cm
1) Anticipated pain
2.8
(0.8 to 5.4)
3.6
(2.0 to 5.5)
2) Pain with injection
1.8
(0.7 to 3.4)
1.2
(0.8 to 2.7)
3) Speculum insertion
2.3
(1.0 to 4.5)
1.5
(0.3 to 3.1)
4) Tenaculum placement
6.3
(3.7 to 7.3)
4.3
(2.2 to 7.1)
5) Uterine sounding
8.4
(6.6 to 9.2)
6.0
(3.9 to 6.7)
6) Pain with IUD placement
8.1
(7.4 to 9.0)
5.4
(5.0 to 7.4)
7) 5 min after placement
3.7
(2.3 to 4.8)
2.7
(1.5 to 3.3)
8) 15 min after placement
4.8
(3.0 to 6.9)
1.8
(0.2 to 3.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 1) anticipated pain
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 2) pain with injection
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 3) speculum insertion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 4) tenaculum placement
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 5) uterine sounding
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 6) IUD placement
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 7) 5 min after placement
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments 8) 15 min after placement
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Post-insertion Patient Questionnaire
Hide Description

Questions assessed in multiple choice format:

  1. Side effects
  2. injection site pain
  3. overall satisfaction with IUD insertion experience
  4. would they still recommend IUD placement to a friend?
  5. significant pain for which they desired acetaminophen prior to leaving the office?
Time Frame assessed at 15 minutes after IUD insertion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo With 1cc Normal Saline IM Toradol, 30mg in 1cc IM
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 34 33
Measure Type: Number
Unit of Measure: participants
Reported side effects 12 8
Injection site pain - just as bad/worse than IUD 8 6
Satisfied or very satisfied with overall IUD proc 30 31
Recommend IUD to a friend 28 30
Desires additional pain medication 16 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments Reported side effects (nausea, vomiting, dyspepsia, headache, dizziness, drowsiness, injection site itchiness, swelling or pain)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value > 0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments Injection site pain (just as bad or worse than IUD procedure)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments Satisfied or very satisfied with IUD placement procedure
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments Would recommend IUD placement to a friend
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments Desires additional pain medication
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Post-insertion Provider Questionnaire
Hide Description

The provider will be asked to fill out a multiple choice format questionnaire:

  1. what level training are you?
  2. which IUD was inserted?
  3. what was the purpose of IUD placement?
  4. what was the position of the uterus?
  5. did the IUD placement process require cervical dilation?
  6. were you able to complete the IUD insertion?
  7. was there bleeding from the cervix that required more than 5 min to control?
  8. were there any major complications with the IUD insertion?
  9. did the patient take tylenol prior to leaving the office?
Time Frame Immediately after IUD placement, on average within 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo With 1cc Normal Saline IM Toradol, 30mg in 1cc IM
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 34 33
Measure Type: Number
Unit of Measure: participants
Level of training - PGY1 2 5
Level of training - PGY2 2 13
Level of training - PGY3 3 6
Level of training - PGY4 5 6
Level of training - Attending 1 3
IUD type - levonogestrel 22 28
IUD type - copper 12 2
Purpose of IUD - contraception 33 32
Purpose of IUD - AUB 1 1
Position of uterus - anteverted 19 20
Position of uterus - retroverted 6 5
Position of uterus - midpositioned 9 8
Cervical dilation needed 2 2
Able to complete the IUD placement 34 33
Significant bleeding 0 2
Major complications 0 0
Took acetaminophen prior to leaving the office 17 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments Level of training, PGY 1, 2, 3, 4 and Attending
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments IUD type (levonorgestrel or copper)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments Purpose of IUD (contraception or heavy menstrual bleeding)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments Position of uterus (anteverted, retroverted, midpositioned)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments Need for cervical dilation
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments Able to complete the IUD insertion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments Significant bleeding
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments Major complications
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo With 1cc Normal Saline IM, Toradol, 30mg in 1cc IM
Comments Took acetaminophen prior to leaving the office
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo With 1cc Normal Saline IM Toradol, 30mg in 1cc IM
Hide Arm/Group Description

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

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

All-Cause Mortality
Placebo With 1cc Normal Saline IM Toradol, 30mg in 1cc IM
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo With 1cc Normal Saline IM Toradol, 30mg in 1cc IM
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo With 1cc Normal Saline IM Toradol, 30mg in 1cc IM
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/33 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lynn Ngo, Lead Study Coordinator/investigator
Organization: BWH
Phone: (617)732-8798
EMail: llngo@partners.org
Layout table for additonal information
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