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Trial record 41 of 465 for:    KETOROLAC

Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage

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ClinicalTrials.gov Identifier: NCT01595282
Recruitment Status : Completed
First Posted : May 10, 2012
Results First Posted : July 2, 2014
Last Update Posted : July 2, 2014
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Planned Parenthood League of Massachusetts

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Ketorolac
Drug: Ibuprofen
Enrollment 94
Recruitment Details

Dates of recruitment period: June 2011-May 2012

Clinic: free-standing, outpatient health center

Pre-assignment Details  
Arm/Group Title Ketorolac Ibuprofen
Hide Arm/Group Description

Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)

Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure

Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo

Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure.

Period Title: Overall Study
Started 47 47
Completed 47 47
Not Completed 0 0
Arm/Group Title Ketorolac Ibuprofen Total
Hide Arm/Group Description

Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)

Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure

Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo

Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure.

Total of all reporting groups
Overall Number of Baseline Participants 47 47 94
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 47 participants 94 participants
26.4  (6.4) 25.3  (4.7) 25.9  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 94 participants
Female
47
 100.0%
47
 100.0%
94
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 94 participants
African American/Black 20 17 37
White 11 14 25
Asian 3 4 7
Multiracial 2 3 5
Other 11 9 20
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants 47 participants 94 participants
47 47 94
1.Primary Outcome
Title Immediate Post-procedure Pain Score
Hide Description The primary endpoint is subjects' immediate post-procedure pain score on a 21-point 0 to 100 scale, 0 = no pain and 100 = worst possible pain (in increments of five). This scale has been previously validated and used for research purposes, including for pain research evaluating suction curettage elsewhere and at our institution (Jensen 1986, Williamson 2004, Allen 2009).
Time Frame Immediately (within 1 minute) after suction and speculum removal
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ibuprofen
Hide Arm/Group Description:

Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)

Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure

Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo

Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure.

Overall Number of Participants Analyzed 47 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
52.3  (29.1) 56.2  (30.2)
2.Secondary Outcome
Title Pain Scores Immediately After Cervical Dilation
Hide Description 21-point 0 to 100 scale where 0 = no pain and 100 = worst possible pain (in increments of five)
Time Frame Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ibuprofen
Hide Arm/Group Description:

Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)

Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure

Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo

Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure.

Overall Number of Participants Analyzed 47 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
41.6  (27.72) 45.4  (28.54)
3.Secondary Outcome
Title Pain Scores 15 Minutes Post-procedure
Hide Description 21-point 0 to 100 scale, where 0 = no pain and 100 = worst possible pain (in increments of five)
Time Frame Fifteen minutes after the procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketorolac Ibuprofen
Hide Arm/Group Description:

Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)

Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure

Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo

Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure.

Overall Number of Participants Analyzed 47 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
22.3  (20.8) 15.0  (17.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketorolac Ibuprofen
Hide Arm/Group Description

Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)

Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure

Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo

Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure.

All-Cause Mortality
Ketorolac Ibuprofen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ketorolac Ibuprofen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/47 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketorolac Ibuprofen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/47 (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: Principal Investigator
Organization: PPLM
Phone: 617-616-1600
Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT01595282     History of Changes
Other Study ID Numbers: 2011-p-000259
First Submitted: May 19, 2011
First Posted: May 10, 2012
Results First Submitted: May 15, 2014
Results First Posted: July 2, 2014
Last Update Posted: July 2, 2014