Intrauterine accessories (IUDs) are safe and awful able bearing control.1 Despite this, they were activated by alone 7.2% of reproductive-aged women in the United States from 2011 to 2013.2 One barrier to application IUDs may be the acumen of affliction complex with placement.3–6
The American College of Obstetricians and Gynecologists recommends demography over-the-counter affliction medication afore IUD placement; however, no specific medication is recommended.7 Methods that accept been advised accommodate nonsteroidal antiinflammatory drugs (NSAIDs), misoprostol, and bounded anesthetics. Despite the use of these medications in practice, few studies accept apparent benefit.8–12 Nonsteroidal antiinflammatory drugs, however, may advice abate pain. Articulate naproxen sodium taken 1 hour afore IUD acclimation may abatement affliction with placement.13,14 However, cat-and-mouse 1 hour may not be accessible in a active clinic.
Intramuscular ketorolac has an admission of analgesia at about 30 minutes. It is a almighty acerb acerbic NSAID. It is adumbrated for concise abstinent astute affliction and is generally acclimated in the postoperative setting.15 The acute aftereffect is at 1–2 hours with a 4- to 6-hour continuance of analgesia.16 In studies of assimilation curettage, use of ketorolac accustomed a abatement in acetaminophen claim postoperatively but no aberration in affliction ascendancy amid ketorolac and ibuprofen.17,18
Ketorolac may be advantageous in the dispensary ambience accustomed its quicker admission of activity compared with articulate medications. This abstraction was advised to appraise whether administering intramuscular ketorolac 30 account afore IUD acclimation would aftereffect in a abridgement in affliction array compared with placebo injection.
This was a randomized, double-blind, placebo-controlled trial. It was accustomed by the University of California San Diego institutional assay board. Application took abode at the University of California San Diego Women’s Bloom Clinics, which is allotment of an burghal bookish institution. Clinicians included obstetrics and gynecology first-, second-, third-, and fourth-year association as able-bodied as accessory physicians.
Women who were acceptable for the abstraction included those ages 18–50 years, nulliparous or multiparous, English- or Spanish-speaking, and those presenting for either levonorgestrel or TCu 380A IUD. Women were afar if they were pregnant, had any diagnosed abiding affliction issues (including fibromyalgia, endometriosis, dysmenorrhea, annoyed bowel syndrome, interstitial cystitis), had taken any affliction medications aural 6 hours of enrollment, had misoprostol aural 24 hours of enrollment, had a history of above-mentioned intrauterine accessory insertion, had a accepted abhorrence or contraindication to NSAIDs, or had any accepted contraindications to IUD placement.
Participants underwent a accord by accomplished registered nurses or by the aboriginal author. They active a accounting accord accustomed by the University of California San Diego institutional assay board, which was accessible in English and Spanish. A application log-tracked patients who were approached and beneath accord or were disqualified for participation.
Patients were randomized to accept either ketorolac 30 mg (1-mL volume) or placebo bang of accustomed acrid (1-mL volume). Bang was into the aerial alien division of the gluteus muscle. A timer was acclimated to adviser back 30 account was completed. The clinicians started the IUD acclimation action anon afterwards the timer alarmed. Time amid abstraction medication administering and IUD acclimation was not recorded.
Randomization was stratified by parity, nulliparous compared with multiparous, with a block admeasurement of four and a one-to-one allocation ratio. The randomization allocation arrangement was computer-generated with a accidental cardinal architect by a statistician not contrarily complex in the study. Accumulation appointment was buried in sealed, numbered, and blurred envelopes opened alone by the dispensary assistant administering the abstraction drug. Clinicians and participants were addled to accumulation allocation. Back available, a addled dispensary agents affiliate administered abstraction forms during the advance of the procedure. However, accustomed assay and dispensary agents limitations, the majority of participants were administered abstraction forms by the unblinded nurse.
The primary aftereffect of absorption was affliction akin abstinent on a beheld analog calibration from 0 cm (no pain) to 10 cm (worst affliction possible) for IUD placement. Accessory outcomes were affliction levels abstinent at six added time points: 1) abstraction biologic administration, 2) speculum placement, 3) tenaculum placement, 4) uterine sounding, 5) 5 account afterwards IUD placement, and 6) 15 account afterwards IUD placement. We additionally abstinent advancing affliction afore abstraction biologic administration. Participants apparent their affliction array anon afterwards anniversary action step. Of note, participants did not accept any analgesic abettor for tenaculum placement.
A postprocedural check was completed by anniversary bloom affliction provider and participant. The bloom affliction provider check calm advice including akin of training, the blazon of IUD placed, the purpose of the IUD placement, uterine position, and any complications. Anniversary accommodating accustomed a check at the 15-minute postprocedure time point, which adjourned for accessible adverse furnishings from the abstraction biologic (including nausea, ing, heartburn, blackout or drowsiness, and bang armpit pain), affliction from the bang compared with affliction with the procedure, all-embracing achievement with the procedure, and admiration for any added affliction medication. Abstraction participants were offered acetaminophen at the 15-minute postprocedure time point (after all beheld analog calibration affliction array were assessed) as added affliction medication and as accession brand of affliction control. We chose acetaminophen because it was readily accessible in our clinic, would not blemish the participant’s adeptness to drive, and was safe to booty with ketorolac. At the cessation of the study, participants were compensated with a allowance card. Charts were advised at a afterwards date to actuate if participants alleged the dispensary aural 24 hours of acceptance to appeal stronger affliction medications.
The ability adding was based on antecedent studies assessing affliction ascendancy with IUD acclimation application a 10-cm (100 mm) beheld analog scale.12,19 A clinically cogent aberration in beheld analog calibration affliction account has been authentic as 1.3–2.0 cm.20,21 Application a accepted aberration of 2.7 cm and a clinically cogent affliction aberration of 2.0 cm, to admission 80% ability with a 5% α absurdity rate, 57 participants were needed.20 To acquiesce allowance for missing abstracts and participants who may discontinue, we planned to recruit about 66 participants with 33 per arm. All abstracts admission was performed alert to ensure accuracy.
The abstracts were analyzed based on an intention-to-treat analysis. For our statistical analysis, we activated the affliction array (continuous variables) for course and they were begin to accept a nonnormal distribution. Therefore, affliction array were compared application the Wilcoxon rank-sum test. We additionally performed a subgroup assay by parity, which was absitively on a priori. For demographics and questionnaires, the χ2 assay was acclimated to analyze absolute variables and the t assay or Wilcoxon rank-sum assay was acclimated to analyze connected variables. Statistical analyses were performed application PASW Statistics 18 and SAS 9.4 software.
Participants were enrolled from July 2012 until March 2014. A absolute of 110 patients were approached for eligibility. Thirty-four of the patients approached to participate were afar because they did not accommodated admittance belief (the majority had a above-mentioned IUD or had taken affliction medications afore the visit). Nine patients beneath to participate for affidavit including not absent to delay and abhorrence of injections. A absolute of 67 participants were randomized with 33 participants allocated to the ketorolac arm and 34 participants allocated to the placebo arm (Fig. 1). All patients randomized accustomed the assigned abstraction drug, underwent acknowledged IUD placement, and completed the study.
There were no differences in baseline demographics including age, anatomy accumulation index, gravidity, parity, race, education, accepted feeding, and above-mentioned history of cone biopsy or a bend electrosurgical excisional action of the cervix. The majority of patients in both groups were either Caucasian or Hispanic. Almost all patients had abounding aerial academy (Table 1).
Median affliction array for all participants were compared amid placebo and ketorolac groups for the primary and accessory outcomes of affliction scores. There was no aberration in advancing affliction amid the two groups (4.4 compared with 3.5 cm, P=.31) or for affliction with abstraction biologic bang (1.0 compared with 0.6 cm, P=.33). Uterine aural (5.0 compared with 4.3 cm, P=.64) and IUD acclimation (5.2 compared with 3.6 cm, P=.99) had the accomplished affliction array afterwards a aberration amid the two groups. There was additionally no aberration for speculum or tenaculum placement. There was a abatement in affliction array at 5 account afterwards IUD acclimation (2.2 compared with 0.3 cm, P≤.001) as able-bodied as at 15 account afterwards IUD acclimation (1.6 compared with 0.1 cm, P≤.001). After-effects for all patients are categorical in Table 2 and Figure 2.
In our subgroup analysis, nulliparous patients (n=16, with eight in anniversary arm) had a abatement in average affliction array with uterine aural (8.4 compared with 6.0 cm, P=.04) and IUD acclimation (8.1 compared with 5.4 cm, P=.02). There was no aberration in affliction array at 5 account afterwards acclimation (3.7 compared with 2.7 cm, P=.32) but there was a abatement at 15 account afterwards acclimation (4.8 compared with 1.8 cm, P=.02). For multiparous patients, there was a abatement in affliction array at 5 account (1.3 compared with 0.1 cm, P≤.001) and 15 account (1.3 compared with 0.0 cm, P≤.001). Of note, average pains array for IUD acclimation were college in the nulliparous subgroup compared with the multiparous subgroup (8.1 compared with 3.7 cm in the placebo arm and 5.4 compared with 2.5 cm in the ketorolac arm) (Table 2).
The postprocedure actor check appear few accessory adverse furnishings from abstraction biologic administering and no aberration amid the two groups. The majority of patients acquainted that the affliction from the bang was “not as bad” as affliction from IUD acclimation (71% compared with 81%). However, 22% in the placebo accumulation and 18% in the ketorolac accumulation appear the affliction was aloof as bad as the IUD acclimation procedure. The majority of patients were actual annoyed or annoyed with their action (90% compared with 93%) and would acclaim IUD acclimation to a acquaintance (85% compared with 91%). There were no statistically cogent differences in these findings, although the abstraction was not powered to appraise these outcomes (Table 3).
The postprocedure bloom affliction provider check appear that at 15 account afterwards IUD placement, decidedly added participants in the placebo accumulation accustomed acetaminophen compared with the ketorolac accumulation (52% compared with 21%, P=.02). No above adverse contest from IUD acclimation were appear by clinicians. There were no differences for blazon of IUD placed (levonorgestrel-releasing or TCu 380A), purpose of IUD acclimation (contraception or menorrhagia), uterine position (anteverted, midpositioned, or retroverted), charge for cervical aborticide (two patients per group), and akin of bloom affliction provider assuming the action (Table 4). On assay of cyberbanking medical records, no participants alleged to appeal stronger affliction medications aural 24 hours of enrollment. Of note, the abstraction was not powered to ascertain a aberration for any of these categories.
In our all-embracing assay we did not acquisition a abatement in affliction array for IUD placement. However, this abstraction was not powered to ascertain a aberration beneath than 2.0 cm. The abstraction does abutment intramuscular ketorolac for abbreviating affliction afterwards IUD placement. This was accustomed with lower affliction array and beneath acetaminophen claim at 15 account afterwards placement.
Nulliparous participants showed a abatement in affliction for uterine aural and IUD placement. However, these after-effects charge be interpreted with caution. The abstraction was not powered for subgroup assay by adequation or added subgroups such as IUD type. A P amount acclimation may advance to a nonsignificant aftereffect for uterine aural and a ambiguous cogent aftereffect for IUD placement. In addition, accustomed the baby sample admeasurement of 16 participants, the after-effects may be the aftereffect of adventitious and may not be generalizable. A balloon powered for subgroup assay may analyze the furnishings of ketorolac.
Although ketorolac has a acute aftereffect at 1–2 hours, we chose to abstraction it at the time of onset, 30 minutes. This was a added astute delay time for our active clinic. This may accept contributed to affliction abridgement acclaimed alone afterwards the IUD action was completed. We did not chase participants accomplished 15 account to abbreviate dispensary breeze interruptions. Although this is a abstraction limitation, compared with added NSAID trials, we did authenticate a postprocedural benefit.
Many of the articulate NSAID trials are bound by abbreviate time to IUD acclimation and abridgement of aftereffect affliction scores. Ibuprofen was administered up to 45 account afore acclimation in three of four trials, so there may not accept been acceptable time for analgesic effect. Affliction afterwards acclimation was not evaluated in these trials. Jensen et al did not beam a aberration during or afterwards acclimation with ibuprofen 1–4 hours afore placement. However, postprocedural affliction was evaluated 4–6 hours afterwards placement, back the ibuprofen may not accept been therapeutic.19,22–24 Naproxen sodium at 550 mg reduces affliction with Multiload Cu 375 IUD placement, although aftereffect affliction array were not evaluated. Of note, this balloon was appear afterwards the alpha of the present trial.13 A balloon of 300 mg naproxen sodium with the Dalkon Shield IUD did not abate affliction with placement, but did abate affliction medication claim postprocedure.14 Naproxen sodium may accept accustomed ability because acceptable time was accustomed for admission of analgesia. Trials anon comparing ability of naproxen, ibuprofen, and ketorolac in a procedural ambience are not available, so it is cryptic if there is a physiologic base for the differences observed.
The backbone of this abstraction is that it is a double-blind, randomized, placebo-controlled trial. Ketorolac is a almost bargain medication, costing about $1 per dose. It can be abounding in clinics. It has a delay time of 30 account compared with 1 hour for articulate NSAIDs with analgesia abiding 4–6 hours. Bang affliction array were considerately low compared with IUD acclimation pain. However, 20% of patients appear their bang armpit affliction afterwards 15 account was aloof as bad as their IUD placement.
There are limitations to this study. Agents administering abstraction forms were unblinded to analysis allocation because of bound assay personnel. This may accept resulted in a bent against a benign effect. However, participants apparent their own affliction account with abstraction agents alone captivation up the beheld analog calibration forms. This helped to absolute abeyant bias. Accession limitation is that ketorolac may not be accessible in all clinics. Back it is given, a bloom affliction provider charge be accessible to administrate the injection.
Patient achievement was aerial behindhand of analysis allocation, acceptable because IUD acclimation is a abbreviate action and all participants had acknowledged placement. Affliction array were college at 15 account compared with 5 account for the nulliparous ascendancy group, the acumen for which is cryptic but may be the aftereffect of added endometrial affliction from the IUD absent an NSAID effect. We did not accomplish ultrasound appraisal to affirm IUD placement, although it may accept been accessible to analyze a baby cardinal of IUD embedment cases.
The accustomed ability of ketorolac in this abstraction is encouraging. However, it is bound by the charge for a potentially aching intramuscular bang and an in-clinic 30-minute delay time. An articulate medication such as naproxen sodium taken afore dispensary accession may be added practical. Added studies on the ability of naproxen sodium during and afterwards IUD acclimation would be helpful. Ultimately, we achievement abbreviating affliction associated with IUD acclimation can advice admission appliance of this awful able contraceptive method.
Obstetrics & Gynecology126(1):29-36, July 2015.
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