ARTICLES Vapor Rub, Petrolatum, and No Treatment for Children With Nocturnal Cough and Cold Symptoms AUTHORS: Ian M. Paul, MD, MSc,a,b Jessica S. Beiler, WHAT’S KNOWN ON THIS SUBJECT: There are few evidence- MPH,a Tonya S. King, PhD,b Edelveis R. Clapp, DO,a Julie based therapies for children with cold symptoms. Topical Vallati, LPN,a and Cheston M. Berlin Jr, MDa aromatic compounds are widely used to treat cold symptoms Departments of aPediatrics and bPublic Health Sciences, Penn without contemporary evidence to support this practice. State College of Medicine, Hershey, Pennsylvania KEY WORDS WHAT THIS STUDY ADDS: A vapor rub combination of camphor, cough, congestion, rhinorrhea, camphor, menthol, eucalyptus, menthol, and eucalyptus oils provided nocturnal symptom relief placebo, upper respiratory infection for children with cold symptoms. Children treated with vapor rub ABBREVIATIONS had improved sleep, as did their parents, when compared with URI—upper respiratory infection children given placebo or no treatment. OTC—over-the-counter VR—vapor rub This trial has been registered at www.clinicaltrials.gov (identifier NCT00743990). www.pediatrics.org/cgi/doi/10.1542/peds.2010-1601 abstract doi:10.1542/peds.2010-1601 Accepted for publication Aug 13, 2010 OBJECTIVE: To determine if a single application of a vapor rub (VR) or petrolatum is superior to no treatment for nocturnal cough, conges- Address correspondence to Ian M. Paul, MD, MSc, Department of Pediatrics, Penn State College of Medicine, HS83, 500 University tion, and sleep difficulty caused by upper respiratory tract infection. Drive, Hershey, PA 17033-0850. E-mail: [email protected] METHODS: Surveys were administered to parents on 2 consecutive PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). days—on the day of presentation when no medication had been given Copyright © 2010 by the American Academy of Pediatrics the previous evening, and the next day when VR ointment, petrolatum FINANCIAL DISCLOSURE: Dr Paul has been a paid consultant for ointment, or no treatment had been applied to their child’s chest and the Consumer Products Healthcare Association, McNeil Consumer Health Inc, the Procter and Gamble Company, Reckitt neck before bedtime according to a partially double-blinded random- Benckiser Healthcare International Ltd, and Novartis Consumer ization scheme. Health Inc; the other authors have indicated they have no financial relationships relevant to this article to disclose. RESULTS: There were 138 children aged 2 to 11 years who completed Funded by the National Institutes of Health (NIH). the trial. Within each study group, symptoms were improved on the second night. Between treatment groups, significant differences in improvement were detected for outcomes related to cough, conges- tion, and sleep difficulty; VR consistently scored the best, and no treat- ment scored the worst. Pairwise comparisons demonstrated the supe- riority of VR over no treatment for all outcomes except rhinorrhea and over petrolatum for cough severity, child and parent sleep difficulty, and combined symptom score. Petrolatum was not significantly better than no treatment for any outcome. Irritant adverse effects were more common among VR-treated participants. CONCLUSIONS: In a comparison of VR, petrolatum, and no treatment, parents rated VR most favorably for symptomatic relief of their child’s nocturnal cough, congestion, and sleep difficulty caused by upper re- spiratory tract infection. Despite mild irritant adverse effects, VR pro- vided symptomatic relief for children and allowed them and their par- ents to have a more restful night than those in the other study groups. Pediatrics 2010;126:000 PEDIATRICS Volume 126, Number 6, December 2010 1 Downloaded from www.aappublications.org/news by guest on September 24, 2021 Upper respiratory infections (URIs) termine if a single application of a va- criteria for enrollment were estab- are the most common acute illnesses por rub (VR) or petrolatum is superior lished. Only parents who answered at in the world,1 and symptoms caused by to no treatment for nocturnal cough, least “moderately often” for cough fre- these infections are disruptive for chil- congestion, and sleep difficulty caused quency and “moderately severe” for dren. The characteristic features of by URIs. We hypothesized that VR or stuffy nose (both equivalent to 4 points URIs are often adversely affected sleep petrolatum would be superior to no on the scale) on the basis of the previ- for both ill children and their parents treatment for relief of nocturnal symp- ous night’s symptoms were eligible. with an effect on subsequent daytime toms and that VR would be superior to After stratification for age (2–5 and activities. In addition to attempting to petrolatum. 6–11 years), each child was randomly improve their comfort, giving medica- assigned in a partially double-blinded tions to children before bed is often an METHODS fashion to 1 of 3 treatment groups: VR attempt by parents to improve their From October 2008 through February ointment (Vicks VapoRub, which con- own sleep and functioning during the 2010, patients were recruited from a tains camphor [4.8%], menthol [2.6%], subsequent day. university-affiliated pediatric practice and eucalyptus oil [1.2%] [Procter and Recent studies2,3 and guidelines4–7 in Hershey, Pennsylvania. Eligible pa- Gamble, Cincinnati, OH]); petrolatum have questioned the efficacy of many tients were aged 2 to 11 years with ointment (Equate 100% pure white pe- oral over-the-counter (OTC) treat- symptoms attributed to URIs charac- troleum jelly [Wal-Mart Inc, Benton- ments for URI symptoms. Clinicians terized by cough, congestion, and rhi- ville, AR]); and no treatment. For the 2 and parents have been left with limited norrhea that lasted 7 days or longer. groups that received an ointment, the therapeutic options to administer to Patients were excluded for signs or dose volume distributed was stratified children with these disruptive symp- symptoms of a more treatable disease according to age: 5 mL (2–5 years) and toms. Alternatives to oral medications (eg, asthma, pneumonia, laryngotra- 10 mL (6–11 years). The randomization are popular topical preparations that cheobronchitis, sinusitis, allergic rhi- sequence was constructed by a statis- contain menthol, camphor, and euca- nitis). They were also ineligible with a tician not affiliated with the study and lyptus oils and have been used in history of asthma, chronic lung dis- was used to assign treatment groups. adults and children for more than a ease, or a seizure disorder. Children All study parents were instructed on century.8–12 with seizure disorders were excluded routine care for children with URI, in- Commenting on camphor-containing because of the reported association of cluding hydration measures, saline products, in 1994 the American Acad- camphor with seizures, particularly af- nose spray use, and use of acetamino- emy of Pediatrics Committee on Drugs ter ingestions of toxic amounts.13 Fi- phen or ibuprofen as needed for com- wrote, “Since alternative agents exist nally, subjects were excluded if on the fort. Because nasal saline could affect for all indications for camphor ther- night before enrollment they used OTC some outcome measures, parents apy, other therapeutic agents that do or prescription medication that con- were asked to not use it within 1 hour not contain camphor should be consid- tained VR components, pseudoephed- of bedtime or throughout the night. ered.”13 The “alternative agent” for rine, phenylephrine, dextromethor- They were instructed not to administer cough and cold symptoms cited by the phan, guaifenesin, diphenhydramine, excluded OTC medications listed above Committee in 1994, dextromethor- brompheniramine, chlorpheniramine, to their child at any time after enroll- phan, was subsequently not recom- or honey. ment and to avoid giving them caffein- mended by that committee 3 years Subjective parental assessments of ated beverages within 4 hours of later in a policy statement on dextro- their child’s symptoms on the previous bedtime. methorphan use.4 Dextromethorphan night were assessed after informed To maintain investigator blinding, all continues not to be recommended,14 and consent was obtained through a mod- study groups received an opaque pa- therefore the question of whether clini- ified version of our previously used per bag that contained a glass speci- cians can recommend topical prepara- and validated questions15 by using a men cup filled with either ointment or tions containing camphor, menthol, and 7-point Likert scale (Fig 1). Trained no treatment. Given the aromatic and eucalyptus oil for URI symptoms in chil- study coordinators were responsible characteristic smell of VR, a series of dren requires reevaluation. for survey administration, and survey steps was required to maintain paren- With no contemporary evidence that responses ranged from most severe tal blinding. First, a second glass spec- supports or refutes the efficacy in chil- symptoms (7 points) to no symptoms imen cup labeled for parents was dren with URIs, this study sought to de- (1 point). Minimum symptom-severity placed in each bag. Although the par- 2 PAUL et al Downloaded from www.aappublications.org/news by guest on September 24, 2021 ARTICLES 1. How OFTEN did your child COUGH last night? □1 □2 □3 □4 □5 □6 □7 Not at all Moderately Very Often Often Often 2. How SEVERE was your child’s COUGH last night? □1 □2 □3 □4 □5 □6 □7 Not at all Moderately Very Severe Severe Severe 3. How SEVERE was your child’s STUFFY NOSE last night? □1 □2 □3 □4 □5 □6 □7 Not at all Moderately Very Severe Severe Severe 4. How SEVERE was your child’s RUNNY NOSE last night? □1 □2 □3 □4 □5 □6 □7 Not at all Moderately Very Severe Severe Severe 5. How much did last night’s cough and cold symptoms affect your CHILD’S ABILITY TO SLEEP? □1 □2 □3 □4 □5 □6 □7 Not at all A moderate Very much amount Much 6.