Transcript Clinical Pearls of Pain Management In Pregnancy

Clinical Pearls of Pain
Management In
Pregnancy
Nikki Eye, Pharm.D.
Clinical Pain Pharmacist
Avera McKennan Hospital
S
Objectives
S Discuss FDA classifications of medications in pregnancy
and lactation
S Review treatment options used for acute and chronic pain in
pregnant women
S Understand the effects of medications on mother, fetus, and
infant during and after pregnancy
Patient Case – Part 1
S MJ, a 27 year old female, presents with ERCP induced
pancreatitis. Her past medical history reports she is ~ 5 weeks
pregnant upon presentation. She recently had a laparoscopic
cholecystecotmy due to biliary stones which resulted in need for
additional follow up. During the ERCP, biliary sludge & stones
were removed along with a CBD stent placement. Post procedure,
patient complains of severe abdominal pain and is admitted to the
hospital for pain management. She was given PRN
Hydrocodone/APAP for pain after initial procedure. Orders for
NPO upon admit. What medications should be initiated at this
time??
What is “pain”??
“An unpleasant sensory and
emotional experience arising
from actual or potential tissue
damage or described in terms
of such damage”.
The International Association for the Study of Pain
-
Pain in pregnancy
S 85% of pregnant women use some type of medication
during pregnancy
S 1. Vitamins/supplements
S 2. Opioids
S More than 14% of American women take powerful narcotic
pain medications during pregnancy
FDA Drug Risk Classification
www.uspharmacist.com
New FDA Classification of medications
in Pregnancy and Lactation
S Three subsections with supporting statements
S Pregnancy
S Lactation
S Females and Males of Reproductive Potential
S Subheadings for “Pregnancy” and “Lactation”
S Risk summary
S Clinical considerations
S Data
Pregnancy
S Provide information relevant to the use of the drug in pregnant
women, such as dosing and potential risks to the developing fetus,
and will require information about whether there is a registry that
collects and maintains data on how pregnant women are affected
when they use the drug or biological product
Lactation
S Provide
information about using the drug while
breastfeeding, such as the amount of drug in breast milk and
potential effects on the breastfed child.
Females and Males of Reproductive Potential
S Includes information about pregnancy testing, contraception
and about infertility as it relates to the drug.
New FDA Classifications Labeling
www.fda.org
Pregnancy Exposure Registry
S Study that collects health information from pregnant
women taking medications
S Collection of data for infant also done
S Compared to women not taking medications
S Enrolling in a pregnancy exposure registry can help improve
safety information for medicines used during pregnancy and
can be used to update drug labeling
Journal of Pain
Recommendation
S Clinicians should counsel women of childbearing potential
about the risks and benefits of chronic opioid therapy
(COT) during pregnancy and after delivery. Clinicians
should encourage minimal or no use of COT during
pregnancy, unless potential benefits outweigh risks. If
chronic opioid therapy is used during pregnancy, clinicians
should be prepared to anticipate and manage risks to the
patient and newborn (strong recommendation, low-quality
evidence).
Teratology and Toxicity of Pain
Meds
S Minimize use of all medications and use non-
pharmacologic therapies
S Consider potential for harm to mother, fetus, and course of
pregnancy
S Protein binding, lipid solubility, speed of maternal metabolism,
& molecular weight
S Most critical period is during organogenesis (4th-10th week
of pregnancy)
Medications in Breast Feeding
S High lipid solubility, low molecular weight, minimal protein
binding, and unionized state cause secretion of medications
into breast milk
S Neonatal dose of most medications obtained through breast
feeding is 1-2% of maternal dose
Medications often used for Pain
during Pregnancy
S Acetaminophen
S
Caffeine
S NSAIDs
S
Triptans
S Opioids
S
Muscle relaxants
S Benzodiazepines
S
TCAs
S Steroids
S
SSRIs/SNRIs
S
Lidoderm
S
Ergot Alkaloids
S
Beta Blockers
Acetaminophen
S Analgesic effect without anti-inflammatory effects
S First line treatment
S Non-teratogenic
S Category B
S Safe in lactation
Non-Steroidal Anti-Inflammatory
Drugs
S Trigger labor
S Prolonged gestation and protracted labor
S Increased risk of peripartum hemorrhage
S Premature antenatal closure of the fetal ductus arteriosus
S Reversible oligohydramnios
Opioids
S Most opioids are classified as Category B or C by FDA
S No evidence to suggest relationship between exposure of
any opioid agonist or agonist-antagonists during pregnancy
and large categories of major/minor malformations
S Neonatal abstinence syndrome
S Excreted into breast milk
Benzodiazepines
S Among most frequently prescribed of all drugs and often
used as anxiolytics or muscle relaxants for chronic pain
S First trimester exposure have increased risk of congenital
malformations
S High coprevalence of alcohol and illicit drug use in patients
using Benzodiazepines
S Avoid during organogenesis, near time of delivery, and
during lactation
Steroids
S Most corticosteroids cross the placenta
S No increase in infant malformations
S Likely safe as steroid epidural therapy
S Lactation - < 1% of maternal prednisone dose appears in
infant
Ergot Alkaloids
S Used to treat migraine headaches
S Category X!!!
S SIGNIFICANT teratogenic risk
S Small doses
S Large doses = uterine contractions and abortions
S Lactation risk
S Neonatal convulsions
S Severe GI disturbances
Beta Blockers
S Used for the maintenance treatment of migraines
S No teratogenic effects
S Fetal effects
S Lactation
S Doses up to 240mg/day (propranolol) have shown minimal
effects on neonate
Caffeine
S Commonly used in combo to treat vascular headaches
S Category B
S 300mg/day limit (= 2 cups of coffee/day)
S High doses can cause fetal/newborn heart rate changes
S Lactation – little effect on infant if limit to 300mg/day
“Triptans”
S Used to terminate migraine headaches
S Sumatriptan (Imitrex) most studied
S Limited data in humans does not show any strong teratogenic
effects
S Labeled as Category C by FDA
S Lactation
S Not well studied
Muscle Relaxants
S Utilized for muscle pains and spasms
S Category B (flexeril) or C (baclofen)
S Should only be used if no alternative options available
S Lactation - unknown, avoid use if possible
Tricyclic Antidepressants
S Used to treat nerve pain
S No direct correlation with fetal malformations
S Possibility of fetal withdrawal symptoms
S Category C
S Lactation – limited data
Serotonin/Norepinepherine
Reuptake Inhibitor
S Cymbalta most widely known for pain management
S FDA approved for diabetic PN, GAD, MDD, Chronic
musculoskeletal pain and fibromyalgia
S No major congenital anomolies reported when used during
pregnancy however some adverse events noted in animals
S Category C
S Lactation – limited data but known to be excreted in the milk
Lidoderm Patches
S Used for musculoskeletal type pain
S Topical use therefore minimal system absorption
S Category B
S No congenital abnormalities or adverse events seen
S Non-narcotic option for chronic back pain
Patient Case Part 2
S MJ was given Fentanyl IVP 50-100 mcg q2hr for severe
pain. She had used ~ 450mcg in 24 hours and continues to
rate pain 8-10/10. Her lipase and amylase have started to
trend down slightly however, she continues to be NPO with
bowel rest at this time. What is the next step for treatment
of MJ’s pain?
Chronic Back Pain
S Nonpharmacologic modalities first line therapy
S Ice, heat, stretching, exercise/PT
S Pharmacologic options
S Acetaminophen
S Lidoderm patches/biofreeze
S Opioids
S Muscle relaxants
Abdominal Pain
S One of the toughest types of pain to treat
S Determine etiology of pain
S Nonpharmacologic intervention first line therapy
S Pharmacologic
S Acetaminophen
S SNRIs
S TCAs
Migraines
S Migraines onset is rare in pregnancy and occurs in ~3% of
patients – typically in 1st trimester
S Nonpharmacologic therapy first line
S Ice, heat, cool compress, acupuncture
S Pharmacologic treatment
S Acetaminophen
S Caffeine
S Triptans – do not use in 3rd trimester
S Beta Blockers
Patient Case – Part 3
S After initiation of a Fentanyl PCA 10mcg IV q10min PRN
along with IVP 50-100 mcg q2hr PRN patient utilized 11001300 mcg/day. She was ordered Lorazepam and Diazepam
PRN for use. Amylase and Lipase continue to be trending
down and plans for possible advancement of diet to liquids.
What should MJ utilize for home pain medications after
reviewing IV use?
Neonatal Abstinence Syndrome
(NAS)
S Neonatal withdrawal after intrauterine exposure to certain drugs
(illicit or prescription)
S Occurs with the abrupt cessation of the drug exposure at birth
S Most commonly seen with opioid exposure, but also seen after
exposure to sedatives, polysubstance abuse, and occasionally
barbiturates and alcohol
S Develops in 55-94% of drug-exposed infants
Symptoms of NAS
Neurological
•Irritability
•Increased wakefulness
•High-pitched cry
•Tremor
•Increased muscle tone
•Hyperactive deep
•tendon reflexes
•Frequent yawning
•Sneezing
•Seizures
Gastrointestinal
Autonomic
•Vomiting
•Diarrhea
•Dehydration
•Poor weight gain
•Poor feeding
•Uncoordinated and
•constant sucking
•Diaphoresis
•Nasal stuffiness
•Fever
•Mottling
•Temperature instability
•Piloerection
•Mild elevations in
•respiratory rate and blood
pressure
University of Iowa Children’s Hospital
Drug
Approximate time to onset of withdrawal
symptoms
Barbiturates
4-7 days but can range from 1-14 days
Cocaine
Usually no withdrawal signs but sometimes
neurobehavioral abnormalities (decreased
arousal and physiologic stress) occur at 48-60
hours
Alcohol
3-12 hours
Heroin
Within 24 hours
Marijuana
Usually no clinical withdrawal signs
Methadone
3 days but up to 5-7 days; rate of severity of
withdraw cannot be correlated to dose of
maternal methadone
Methamphetamines
Usually no withdrawal signs but sometimes
neurobehavioral abnormalities (decreased
arousal, increased physiologic stress, and poor
quality of movement) occur at 48-60 hours
Opioids
24-36 hours but can be up to 5-7 days
Sedatives
1-3 days
SSRIs
Several hours to several days—withdrawal
linked with 3rd trimester use
Medications to treat NAS
S Nonpharmacologic treatment
S First line treatment
S Morphine (0.05 mg/kg PO q4 hrs)
S Methadone (0.05 mg/kg PO every 12 hours)
S Buprenorphine
S 4.4 mcg/kg PO q8hr
S Clonidine
S 1 mcg/kg PO every 4 hours
Conclusions
S Very limited data to support the safety profile of pain
medications use during pregnancy
S Chronic opioid therapy should be maintained throughout
the entire pregnancy if patient has not weaned off
medications prior to conception or early into pregnancy
S Medications used for pain during pregnancy should be
determined on a case by case basis and benefits should be
weighed against risks
Questions
References
S
Rathmell JP, Viscomi CM, Ashburn MA. Management of non-obstetric pain during
pregnancy and lactation. Anesth Analg. 1997; 85:1074-87.
S
Keltman Pharmaceuticals Inc. Flexeril. Prescribing information. Available from:
http://www.drugs.com/pro/flexeril.html; 2010 [accessed 23.12.11].
S
Cassina M, Di Gianantonio E, Toldo I, Battistella PA, Clementi M. Migraine therapy during
pregnancy and lactation. Expert Opin Drug Saf. 2010; 9:937-48.
S
University of Iowa children’s Hospital. Protocol on Neonatal Abstinence Syndrome treatment
guidelines
S
Einarson A, Bozzo P, Taguchi N. Use of a fentanyl patch throughout pregnancy. J Obstet
Gynaecol Can. 2009;31(1):20.
References
S
Contag SA, Bushnell C. Contemporary management of migrainous disorders in pregnancy.
S
Ostgaard HC, Andersson GB, Karlsson K. Prevalence of back pain in pregnancy. Spine (Phila
Pa 1976). 1991; 16:549-52.
S
U.S. Food and Drug Administration. Summary of proposed rule on pregnancy and lactation
labeling. Available from:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling
/ucm093310.htm; 2009
S
Ives TJ, Tepper RS. Drug use in pregnancy and lactation. Prim Care. 1990; 17:623-45.
S
Kraft WK, et al. Sublingual Buprenorphine for the treatment of Neonatal Abstinence
Syndrome: a randomized trial. Pediatrics. 2008 Sep;122(3):e601-7
Curr Opin Obstet Gynecol. 2010; 22:437-45.