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Completed

NCT Number: NCT01595282

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

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 names: Toradol

Ibuprofen

Drug

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Planned Parenthood League of Massachusetts

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage: a Randomized Clinical Trial.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 10, 2012
Registry last updated
Jul 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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