Pain relievers for children with acute middle ear infection (2023)

Review question

We wanted to find out if pain relievers are effective for relieving pain in children with acute middle ear infection (acute otitis media (AOM)) and which medications, alone or together, provide the most effective pain relief.

Background

Acute middle ear infection or AOM is one of the most common childhood infections. Ear pain due to middle ear infection and pressure building up behind the eardrum is the key symptom of AOM and central to children's and parents' experience of the illness. Because antibiotics provide only marginal benefits, pain relievers such as paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs) are considered the cornerstone of AOM management in children.

Search date

Our evidence is current to 19 August 2016.

Study characteristics

We included data from three trials of low to moderate risk of bias of 327 children with AOM. One trial (219 children) compared paracetamol versus ibuprofen versus a dummy drug in children with AOM. In this trial, all children also received antibiotic treatment and those with fever > 39 °C may have received paracetamol in addition to the studied treatments. Two other trials compared the effects of paracetamol versus ibuprofen versus ibuprofen plus paracetamol in children with fever and patients with respiratory tract infections, respectively. The authors of these two trials provided crude subgroup data on children with AOM (26 and 82 children, respectively).

Study funding sources

(Video) Middle Ear Infection (Acute Otitis Media) | Causes, Symptoms, Diagnosis, Treatment

In one trial, paracetamol, ibuprofen and a dummy drug were supplied by a pharmaceutical company (Ethypharm). No further details were provided about the role of this company in the design, conduct, analysis, or reporting of the trial. The other two trials were funded by governmental (non-commercial) grants. In one trial the drugs were purchased from and provided by two companies (Pfizer and DHP Investigational Medicinal Products) which had no role in the design, conduct, analysis, or reporting of the trial.

Key results

Very limited information was available to assess how useful painkillers are for relieving children's pain due to AOM. We found that both paracetamol and ibuprofen when used alone were more effective than a dummy drug in relieving ear pain at 48 hours (25% of children receiving a dummy drug had residual pain at 48 hours versus 10% in the paracetamol group and 7% in the ibuprofen group). The adverse events reported in the trials did not significantly differ between children treated with either paracetamol, ibuprofen or dummy drug, but this finding should be interpreted cautiously, given there were few participants, and infrequent occurrence of adverse events. We found insufficient evidence of a difference between paracetamol and ibuprofen in relieving short-term (at 24 hours, 48 to 72 hours and 4 to 7 days) ear pain in children with AOM. We could not draw any firm conclusions on the effects of ibuprofen plus paracetamol versus paracetamol alone in relieving ear pain in children with AOM mainly because of the very limited number of participants (very small sample size).

Quality of evidence

Evidence quality for ear pain relief at 48 hours for the comparisons paracetamol versus a dummy drug and ibuprofen versus a dummy drug was judged low (study limitations and questions about the applicability of evidence affected our confidence in the results); the quality of evidence for adverse events was judged very low (study limitations, small sample size and infrequent occurrence of adverse events affected our confidence in the results).

Evidence quality for ear pain relief at 48 to 72 hours for the comparison ibuprofen versus paracetamol was judged low (study limitations and questions about the applicability of evidence affected our confidence in the results); the quality of evidence for ear pain relief at 24 hours and four to seven days was judged very low (study limitations and very small sample size affected our confidence in the results).

Evidence quality for all outcomes in the trials comparing ibuprofen plus paracetamol versus paracetamol alone was very low (study limitations and very small sample size affected our confidence in the results).

Authors' conclusions:

Despite explicit guideline recommendations on its use, current evidence on the effectiveness of paracetamol or NSAIDs, alone or combined, in relieving pain in children with AOM is limited. Low quality evidence indicates that both paracetamol and ibuprofen as monotherapies are more effective than placebo in relieving short-term ear pain in children with AOM. There is insufficient evidence of a difference between ibuprofen and paracetamol in relieving short-term ear pain in children with AOM, whereas data on the effectiveness of ibuprofen plus paracetamol versus paracetamol alone were insufficient to draw any firm conclusions. Further research is needed to provide insights into the role of ibuprofen as adjunct to paracetamol, and other analgesics such as anaesthetic eardrops, for children with AOM.

(Video) How to manage your child’s ear infection

Read the full abstract...

Background:

Acute otitis media (AOM) is one of the most common childhood infectious diseases and a significant reason for antibiotic prescriptions in children worldwide. Pain from middle ear infection and pressure behind the eardrum is the key symptom of AOM. Ear pain is central to children's and parents' experience of the illness. Because antibiotics provide only marginal benefits, analgesic treatment including paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs) is regarded as the cornerstone of AOM management in children.

Objectives:

Our primary objective was to assess the effectiveness of paracetamol (acetaminophen) or NSAIDs, alone or combined, compared with placebo or no treatment in relieving pain in children with AOM. Our secondary objective was to assess the effectiveness of NSAIDs compared with paracetamol in children with AOM.

Search strategy:

We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 7, July 2016; MEDLINE (Ovid, from 1946 to August 2016), Embase (from 1947 to August 2016), CINAHL (from 1981 to August 2016), LILACS (from 1982 to August 2016) and Web of Science (from 1955 to August 2016) for published trials. We screened reference lists of included studies and relevant systematic reviews for additional trials. We searched WHO ICTRP, ClinicalTrials.gov, and the Netherlands Trial Registry (NTR) for completed and ongoing trials (search date 19 August 2016).

(Video) Acute Otitis Media (Causes, Pathophysiology, signs and symptoms, treatment and complications)

Selection criteria:

We included randomised controlled trials (RCTs) comparing the effectiveness of paracetamol or NSAIDs, alone or combined, for pain relief in children with AOM. We also included trials of paracetamol or NSAIDs, alone or combined, for children with fever or upper respiratory tract infections (URTIs) if we were able to extract subgroup data on pain relief in children with AOM either directly or after obtaining additional data from study authors.

Data collection and analysis:

Two review authors independently assessed methodological quality of the included trials and extracted data. We used the GRADE approach to rate the overall quality of evidence for each outcome of interest.

(Video) Middle Ear Infection (Otitis Media), Causes, SIgns and Symptoms, Diagnosis and Treatment.

Main results:

We included three RCTs (327 children) which were assessed at low to moderate risk of bias.

One RCT included 219 children with AOM, and used a three-arm, parallel group, double-blind design to compare paracetamol versus ibuprofen versus placebo. All children also received antibiotics and those with fever > 39 °C could have received paracetamol (30 mg to 60 mg) additionally to the studied treatments.

Another RCT involved 156 febrile children (26 of whom had AOM). The study design was a three-arm, parallel group, double-blind design and compared paracetamol versus ibuprofen versus ibuprofen plus paracetamol.

The third RCT included 889 children with respiratory tract infections (82 of whom had AOM). This study applied a 3 x 2 x 2 factorial, open-label design and compared paracetamol versus ibuprofen versus ibuprofen plus paracetamol. Study participants were randomised to one of the three treatment groups as well as two dosing groups (regular versus as required) and two steam inhalation groups (steam versus no steam).

Authors of two RCTs provided crude subgroup data on children with AOM. We used data from the remaining trial to inform comparison of paracetamol versus placebo (148 children) and ibuprofen versus placebo (146 children) assessments. Data from all included RCTs informed comparison of ibuprofen versus paracetamol (183 children); data from the two RCTs informed comparison of ibuprofen plus paracetamol versus paracetamol alone (71 children).

We found evidence, albeit of low quality, that both paracetamol and ibuprofen as monotherapies were more effective than placebo in relieving pain at 48 hours (paracetamol versus placebo: proportion of children with pain 10% versus 25%, RR 0.38, 95% CI 0.17 to 0.85; number needed to treat to benefit (NNTB) 7; ibuprofen versus placebo: proportion of children with pain 7% versus 25%, RR 0.28, 95% CI 0.11 to 0.70; NNTB 6). Very low quality evidence suggested that adverse events did not significantly differ between children treated with either paracetamol, ibuprofen or placebo.

We found insufficient evidence of a difference between ibuprofen and paracetamol in relieving ear pain at 24 hours (2 RCTs, 39 children; RR 0.83, 95% CI 0.59 to 1.18; very low quality evidence), 48 to 72 hours (3 RCTs, 183 children; RR 0.91, 95% CI 0.54 to 1.54; low quality evidence) and four to seven days (2 RCTs, 38 children; RR 0.74, 95% CI 0.17 to 3.23; very low quality evidence).

(Video) Middle Ear Infections in Children | Merck Manual Consumer Version Quick Facts

Data on the effectiveness of ibuprofen plus paracetamol versus paracetamol alone came from two RCTs that provided crude subgroup data for 71 children with AOM. The small sample provided imprecise effect estimates and we were consequently unable to draw any firm conclusions (very low quality evidence).

FAQs

What painkiller is best for ear infection? ›

Your doctor may advise the use of over-the-counter acetaminophen (Tylenol, others) or ibuprofen (Advil, Motrin IB, others) to relieve pain. Use the drugs as directed on the label. Use caution when giving aspirin to children or teenagers.

What is the best medicine for middle ear infection? ›

Here are some of the antibiotics doctors prescribe to treat an ear infection:
  • Amoxil (amoxicillin)
  • Augmentin (amoxicillin/potassium clavulanate)
  • Cortisporin (neomycin/polymxcin b/hydrocortisone) solution or suspension.
  • Cortisporin TC (colistin/neomycin/thonzonium/hydrocortisone) suspension.
26 Nov 2018

How do you treat a middle ear infection in a child? ›

How is an acute middle ear infection treated? Many doctors will prescribe an antibiotic, such as amoxicillin, to be taken over seven to 10 days. Your doctor also may recommend over-the-counter pain relievers such as acetaminophen or ibuprofen, or eardrops, to help with fever and pain.

Can I take Tylenol for middle ear infection? ›

Pain from ear infections can be treated with an OTC pain reliever. To treat the pain associated with ear infections, the AAP and the American Academy of Family Physicians recommend use of an over-the-counter (OTC) pain reliever—like TYLENOL® or MOTRIN®—as stand-alone treatment or in combination with antibiotics.

What can you do for extreme ear infection pain? ›

Here are options to try:
  1. Over-the-counter (OTC) pain and fever reliever. ...
  2. Warm compress. ...
  3. Rest. ...
  4. Saltwater gargle. ...
  5. Drying eardrops for an ear infection. ...
  6. Hydrogen peroxide. ...
  7. Home remedies used to treat related illnesses. ...
  8. Avoid using Q-tips for ear infection cleaning.

What helps ear pain in kids? ›

Caring for Ear Pain

Ear pain may be worse when lying down; so try to have child sit or sleep with head elevated. Warm compresses may help ease ear discomfort. (However, take care not to burn the skin). Acetaminophen or ibuprofen can be used to help discomfort; following instructions on label or given by physician.

Why is middle ear infection so painful? ›

Ear infections happen when viruses or bacteria get into the middle ear, the space behind the eardrum. When a child has an ear infection (also called otitis media), the middle ear fills with pus (infected fluid). The pus pushes on the eardrum, which can be very painful.

How painful is a middle ear infection? ›

Infection can cause: Earache – mild to severe pain in the ear or face or pulling at the ear and irritability in an infant. Fever – a high temperature might be the only symptom in babies or young children. Mild deafness – caused by fluid which builds up from the infection.

Can a child get over an ear infection without antibiotics? ›

Most ear infections go away without treatment. "If your child isn't in severe pain, your doctor may suggest a 'wait-and-see' approach coupled with over-the-counter pain relievers to see if the infection clears on its own," Tunkel says.

Is ibuprofen or Tylenol better for ear infection? ›

To best fight the pain associated with the infection, alternating Tylenol and Motrin is the best option for immediate relief. However, if the infection is bacterial as opposed to viral, antibiotics such as amoxicillin or ofloxacin will be the best option for fighting off the infection.

Is Tylenol or ibuprofen better for ear pain? ›

Ibuprofen basics

As the name suggests, it tends to be most helpful for discomfort that goes hand in hand with inflammation, which can include redness, swelling, heat, pain and/or loss of function at the site or source. That makes it a smart pick for pain such as: Back and neck pain. Earache.

Can I give my child Tylenol for ear pain? ›

One of the most common medications used to relieve ear pain is acetaminophen, including Infants' or Children's TYLENOL®. As with any medicine, ask your doctor or pediatrician which pain reliever is right for your child.

How can I get immediate relief from ear infection? ›

Nine home remedies for earache
  1. Over-the-counter medication. Share on Pinterest Anti-inflammatory drugs can help relieve the pain and discomfort. ...
  2. Heat. Heat from an electric heating pad or hot pack can reduce inflammation and pain in the ear. ...
  3. Cold. ...
  4. Ear drops. ...
  5. Massage. ...
  6. Garlic. ...
  7. Onions. ...
  8. Sucking.

How long does it take for a middle ear infection to stop hurting? ›

Treating middle ear infections

Most middle ear infections (otitis media) clear up within three to five days and don't need any specific treatment. You can relieve any pain and a high temperature using over the counter painkillers such as paracetamol and ibuprofen.

Should I go to the ER for severe ear pain? ›

Seek emergency care if you have any of the following symptoms: Pain in an ear with or without fever. Itching of the ear or ear canal. Loss of hearing or difficulty hearing in one or both ears.

How can I keep my child comfortable at night with the pain of an ear infection? ›

Warm compresses can provide some temporary pain relief. Moist heat is preferable, so use a clean washcloth dipped in warm water or a microwavable hot pack designed to be misted with water. Being mindful of the temperature, apply the compress over the ear for 10 to 15 minutes. This can be especially helpful at bedtime.

How do you sleep with a middle ear infection? ›

Sleep position

Rest with your head on two or more pillows, so your affected ear is higher than the rest of your body. Or if your left ear has an infection, sleep on your right side. Less pressure equals less ear pain. It could be effective, though a few inches may not make a big difference in pressure measurement.

What type of ear infection hurts the most? ›

Acute mastoiditis is infection of this bone, caused by prior acute otitis media. The symptoms include reddened and swollen skin over the mastoid, fever, discharge from the ear and intense pain. This is a serious condition.

What happens if your ear infection won't go away with antibiotics? ›

Call your healthcare provider during office hours if: The fever remains or comes back more than 48 hours after starting an antibiotic. Ear pain is not better after three days of taking an antibiotic. Ear pain is severe.

How do you drain fluid from your middle ear at home? ›

Tilt your head sideways, and rest your ear onto your cupped palm, creating a tight seal. Gently push your hand back and forth toward your ear in a rapid motion, flattening it as you push and cupping it as you pull away. Tilt your head down to allow the water to drain.

What is the difference between a middle ear infection and an inner ear infection? ›

Problems hearing out of the infected ear is more common in inner ear infections than in middle ear infections. Inner ear infections also may cause symptoms of nausea, vomiting, and dizziness, which usually are not symptoms of middle ear infections.

How long does it take for an ear infection to heal with antibiotics in kids? ›

Once on antibiotics, your child will get better in 2 or 3 days. Make sure you give your child the antibiotic as directed. The fever should be gone by 2 days (48 hours). The ear pain should be better by 2 days.

How long does it take for an ear infection to heal with antibiotics? ›

How Long Does It Take for an Ear Infection to Clear Up? Many mild ear infections will clear up in two or three days. If antibiotics are prescribed, the course is usually 10 days. However, fluid in the ear may linger for a few weeks even after the infection clears up.

How do you know if an ear infection is viral or bacterial? ›

If the ear infection goes away on its own within a week or so, you can assume it was caused by a virus. If it isn't improving after a week, it might be a bacterial infection and you should definitely seek medical treatment.

How do you rotate between Tylenol and ibuprofen? ›

How do you give acetaminophen and ibuprofen together? Doses of acetaminophen (e.g., Tylenol, Tempra) should be given at least four hours apart. Doses of ibuprofen (e.g., Advil, Motrin) should be given at least six hours apart. There are limits on how much of each medication can be given in a 24-hour period.

Does acetaminophen help ear pain? ›

The important immediate treatment is pain relief. A weight-based dose of acetaminophen (Tylenol) or ibuprofen (Motrin/Advil), sleeping upright, and a warm washcloth or heating pad over the ear usually helps within 30-45 minutes.

Which is better children's Tylenol or ibuprofen? ›

A few studies have suggested ibuprofen may be better than acetaminophen in helping to treat fevers over 102 – 103 F, while acetaminophen may be better for children who are also having stomach pain or upset, because ibuprofen can sometimes irritate the stomach.

Can we use painkiller for ear pain? ›

If your earache is caused by a middle ear infection, it's likely to get better on its own within 7 days and usually won't need antibiotics. Until the pain gets better, you can use simple pain relief medicines like paracetamol or ibuprofen.

Is paracetamol or ibuprofen better for ear infection? ›

We found insufficient evidence of a difference between ibuprofen and paracetamol in relieving ear pain at 24 hours (2 RCTs, 39 children; RR 0.83, 95% CI 0.59 to 1.18; very low quality evidence), 48 to 72 hours (3 RCTs, 183 children; RR 0.91, 95% CI 0.54 to 1.54; low quality evidence) and four to seven days (2 RCTs, 38 ...

What is the fastest way to relieve ear pain? ›

Here are 11 home remedies and over-the-counter treatments for earaches.
  1. Over-the-counter pain relievers. ...
  2. Cold or warm compresses. ...
  3. Olive oil. ...
  4. Naturopathic drops. ...
  5. Chiropractic treatment. ...
  6. Sleep without putting pressure on the ear. ...
  7. Neck exercises. ...
  8. Ginger.

Can painkiller stop ear pain? ›

If your earache is caused by a middle ear infection, it's likely to get better on its own within 7 days and usually won't need antibiotics. Until the pain gets better, you can use simple pain relief medicines like paracetamol or ibuprofen.

Will pain killers help ear ache? ›

How can I treat earache at home? You can ask your pharmacist about using over-the-counter painkillers such as paracetamol or ibuprofen to treat the pain. Children under the age of 16 should not take aspirin. Placing a warm flannel against the affected ear may also help relieve the pain.

Would ibuprofen help with ear pain? ›

The important immediate treatment is pain relief. A weight-based dose of acetaminophen (Tylenol) or ibuprofen (Motrin/Advil), sleeping upright, and a warm washcloth or heating pad over the ear usually helps within 30-45 minutes.

Does ibuprofen reduce ear inflammation? ›

Decongestants: These medicines (e.g., Sudafed, Afrin nasal spray) reduce swelling in the mucous membranes, which helps to open up passages to the ear and relieve symptoms. Pain relievers: OTC pain relievers like acetaminophen and ibuprofen can help with minor discomfort and inflammation.

How do you relieve ear pressure and pain? ›

Home remedies: Sometimes simply chewing gum can help as this can force the eustachian tubes to open as you're chewing and swallowing. To ease discomfort, you can try breathing in steam in the shower or with a humidifier or rinsing your nasal passages with saline.

What medicine gets rid of ear pain? ›

Antipyrine and benzocaine otic is used to relieve ear pain and swelling caused by middle ear infections. It may be used along with antibiotics to treat an ear infection. It is also used to help remove a build up of ear wax in the ear. Antipyrine and benzocaine are in a class of medications called analgesics.

How should I sleep with ear pain? ›

Sleep position

Rest with your head on two or more pillows, so your affected ear is higher than the rest of your body. Or if your left ear has an infection, sleep on your right side. Less pressure equals less ear pain. It could be effective, though a few inches may not make a big difference in pressure measurement.

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