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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

Tracking Information
First Submitted Date  ICMJE May 19, 2011
First Posted Date  ICMJE May 10, 2012
Results First Submitted Date  ICMJE May 15, 2014
Results First Posted Date  ICMJE July 2, 2014
Last Update Posted Date July 2, 2014
Study Start Date  ICMJE June 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2014)
Immediate Post-procedure Pain Score [ Time Frame: Immediately (within 1 minute) after suction and speculum removal ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
Immediate Post-procedure Pain Score [ Time Frame: Immediately (within 1 minute) after suction and speculum removal ]
The primary endpoint is subjects' immediate post-procedure pain score on a 21-point 0 to 100 scale (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).
Change History Complete list of historical versions of study NCT01595282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2014)
  • Pain Scores Immediately After Cervical Dilation [ Time Frame: Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula ]
    21-point 0 to 100 scale where 0 = no pain and 100 = worst possible pain (in increments of five)
  • Pain Scores 15 Minutes Post-procedure [ Time Frame: Fifteen minutes after the procedure ]
    21-point 0 to 100 scale, where 0 = no pain and 100 = worst possible pain (in increments of five)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
  • Pain Scores Immediately After Cervical Dilation [ Time Frame: Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula ]
    21-point 0 to 100 scale (in increments of five)
  • Pain Scores 15 Minutes Post-procedure [ Time Frame: Fifteen minutes after the procedure ]
    21-point 0 to 100 scale (in increments of five)
  • Change in Subjective pain score [ Time Frame: immediately after cervical dilation, immediately after the procedure, and 15 minutes after the procedure ]
    We will measure pain on a subjective scale of "no pain, mild pain, moderate pain or severe pain."
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage
Official Title  ICMJE Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage: a Randomized Clinical Trial.
Brief Summary

The aim of this study is to compare the effect of pre-procedural ketorolac to ibuprofen on immediate post-procedural pain scores in patients undergoing first trimester suction curettage with local anesthesia only.

Our primary hypothesis is that IM ketorolac compared to oral ibuprofen will result in an approximate 30% reduction in pain scores on a 21-point numerical rating scale immediately after the procedure.

Secondary hypotheses include:

  • Pain scores on the 21-point scale will also be significantly lower in the ketorolac group immediately after cervical dilation and 15 minutes post-procedure.
  • Fewer patients in the ketorolac group will rate their pain as "severe" on a subjective pain rating scale.
  • Patients in the ketorolac group will be more satisfied with their pain control.
  • Side effects will be similar between groups.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: 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
    Other Name: Toradol
  • Drug: 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.
Study Arms  ICMJE
  • Experimental: Ketorolac
    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)
    Intervention: Drug: Ketorolac
  • Active Comparator: Ibuprofen
    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
    Intervention: Drug: Ibuprofen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2012)
94
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women age 18 or older seeking suction curettage at Planned Parenthood League of Massachusetts (PPLM)
  • Gestational age less than or equal to 11+6, confirmed by ultrasound
  • Eligible for suction curettage according to PPLM protocols
  • Choice of local anesthesia

Exclusion Criteria:

  • Choice of IV sedation for pain control
  • Hypersensitivity to NSAIDs or lidocaine
  • Contraindications to NSAIDs:

Active renal disease Active hepatic disease Gastric ulcer disease or gastritis Long-term NSAID or aspirin use Bleeding disorder

  • NSAIDs taken < 8 hours prior to procedure
  • Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)
  • Long-term narcotic use
  • Unable or unwilling to complete required study procedures
  • Previous participation in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595282
Other Study ID Numbers  ICMJE 2011-p-000259
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Planned Parenthood League of Massachusetts
Study Sponsor  ICMJE Planned Parenthood League of Massachusetts
Collaborators  ICMJE Society of Family Planning
Investigators  ICMJE
Principal Investigator: Principal Investigator, MD, MPH Planned Parenthood League of Massachusetts
PRS Account Planned Parenthood League of Massachusetts
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP