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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Drug: Ketorolac Drug: Ibuprofen Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage: a Randomized Clinical Trial.
Study Start Date : June 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

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Arms and Interventions
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Arm Intervention/treatment
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)
 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
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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595282


Locations
United States, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Society of Family Planning
Investigators
Principal Investigator: Principal Investigator, MD, MPH Planned Parenthood League of Massachusetts
More Information
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Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT01595282     History of Changes
Other Study ID Numbers: 2011-p-000259
First Posted: May 10, 2012    Key Record Dates
Results First Posted: July 2, 2014
Last Update Posted: July 2, 2014
Last Verified: June 2014

Keywords provided by Planned Parenthood League of Massachusetts:
pain
suction curettage

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action